Treatment Trials

48 Clinical Trials for Various Conditions

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RECRUITING
Inhalational or Intravenous Anesthesia During Surgery for Patients With Colon Cancer, VIVA Study
Description

This trial evaluates how inhalational anesthesia (drawn in through the lungs) and total intravenous anesthesia (TIVA) (through a needle in a vein in the arm) change the body's ability to recover from surgery or whether they impact the immune system immediately after surgery in patients with colon cancer. It is unknown whether these types of anesthesia change recovery from surgery or change the chances cancer comes back following surgery. This study may help researchers learn how different types of anesthesia affect recovery from colon cancer surgery.

RECRUITING
Total Intravenous Anesthesia (TIVA)/Sevoflurane Initiated Intravenous Anesthesia (SIIVA) in Pediatric Patients
Description

Because Propofol is the primary "anesthetic agent," and inhalational agents remain in trace quantities at the end of the procedure Sevoflurane initiated intravenous anesthesia (SIIVA) or not present at all Total intravenous anesthesia (TIVA) it is likely that different criteria may be predictive of extubation success in these patients compared to inhalational anesthesia.

Conditions
COMPLETED
Impact of Total Intravenous Anesthesia Following Cancer Surgery, TIVACS Study
Description

This phase II trials studies the impact of total intravenous anesthesia (TIVA) following cancer surgery. Surgery and the anesthesia delivered causes physiologic stress and trauma resulting in immune suppression. TIVA is an alternative method of general anesthesia that has several benefits over volatile inhalation agents such as reducing nausea, vomiting, and opioid consumption, and promotes earlier return of bowel function following surgery. In addition, TIVA is less immunosuppressive than inhalational agents and has been shown to decrease cancer cell proliferation, migration, and metastasis formation. Giving TIVA during cancer-directed abdominal surgery may decrease the immunosuppressive state in the peri-surgical period.

COMPLETED
Efficacy and Safety of a Single Syringe Total Intravenous Anesthesia With Propofol and Remifentanil: A Prospective Cohort Study
Description

The purpose of this prospective observational study was to evaluate the efficacy and safety of single syringe TIVA with propofol and remifentanil. The primary outcome for efficacy was a processed EEG (pEEG) index within the recommended range for general anesthesia for the duration of the maintenance anesthetic. The primary outcome measure for safety was intraoperative administration of vasopressors. We hypothesized that the pEEG index would be within the recommended range for over 90% of the duration of the maintenance anesthetic. We hypothesized that vasopressor use would be consistent with other anesthetic types using potent inhaled agents.

Conditions
ENROLLING_BY_INVITATION
Total Intravenous Anesthesia With Propofol vs. General Anesthesia in Outpatient Shoulder Arthroscopic Surgeries
Description

This study is comparing total intravenous anesthesia with propofol with a regional nerve block against general anesthesia with a regional nerve block on the primary endpoint of time to meet discharge criteria.

COMPLETED
Optiflow THRIVE for Delivery of Oxygen to Patients During Total Intravenous Anesthesia While Undergoing Radiology Procedures
Description

This trial studies how well Optiflow THRIVE works in delivering oxygen to patients during total intravenous anesthesia while undergoing radiology procedures. The Optiflow THRIVE is an oxygen administration device that delivers high-flow and humidified oxygen through the nose. The Optiflow THRIVE device may improve oxygen delivery and reduce breathing complications.

COMPLETED
Total Intravenous Anesthesia in Sinus Surgery
Description

Utilization of total intravenous anesthesia (TIVA) has been proposed as a method to improve visualization during endoscopic sinus surgery (ESS), largely due to its physiologic decrease in cardiac output without the peripheral smooth muscle relaxation and resultant vasodilation associated with inhaled anesthetics. This may be especially important in cases of advanced inflammatory sinus disease, when visualization may be most compromised. The goal of this study is to improve clinical practice paradigms by evaluating the use of TIVA versus inhaled anesthetic for maintenance of anesthesia in ESS for advanced paranasal sinus disease.

COMPLETED
A Novel Method for Capturing the Visual Evoked Potential During Spine Surgery Under Total Intravenous Anesthesia
Description

Spine surgery in the prone position (which involves lying face down) is associated with various visual changes, ranging from temporary changes in acuity (or sharpness) to permanent blindness. Known risk factors include low blood count (anemia) and long surgical times in the prone position under general anesthesia. While blindness is a rare outcome of this surgery, it is devastating and incompletely prevented by controlling known risk factors. Thus, improved monitoring and detection of visual injury during surgery is necessary. The purpose of this study is to determine whether a novel, non-invasive monitoring device can reliably record visual responses during spine surgery. The first phase of this study is completed and involved patients undergoing microdiscectomy surgery. The second phase of this study involves patients undergoing single-level lumbar spine decompression/fusion surgery.

COMPLETED
Dexmedetomidine vs Propofol TIVA (Total Intravenous Anesthesia) and Interscalene Block
Description

The standard hospital procedure calls for the patient to undergo Interscalene block under ultrasound with or without nerve stimulation guidance prior to going to operating room (OR). The block utilizes a 40 ml mixture of 0.5% Ropivacaine and Lidocaine 1.5%. At this time the patient receives preliminary sedation with Midazolam 1mg IV and Fentanyl 50 mcg IV. The participant is then brought to the OR and prolonged sedation is initiated, randomly using either Dexmedetomidine or Propofol. The primary objective of the present study is to use Dexmedetomidine for sedation, and compare the outcomes with Propofol sedation. The investigators will enroll 50 patients for this study. Our hypothesis is that Dexmedetomidine will cause fewer episodes of intermittent apnea, and reduced need for supplemental medication for sedation, compared to Propofol

Conditions
TERMINATED
Correlation of Bispectral Index Score and Total Intravenous Anesthesia (TIVA)
Description

General Anesthesia is usually produced by an intravenous agent and then maintained with a breathing agent till the surgery is completed. However, there is a recent trend to produce and maintain general anesthesia solely with an intravenous agent, such as propofol, in view of its advantages. This delivery method is called Total Intravenous Anesthesia (TIVA). The depth of general anesthesia can be measured by an anesthetic depth monitoring device called Bispectral Index (BIS). The use of BIS to determine the depth of anesthesia has been well established whenever a breathing agent is used to maintain general anesthesia. However, the validity of using BIS with TIVA has not been adequately investigated. This study will compare the BIS values at different doses of TIVA in order to establish any correlation between the two. If such a correlation is established, BIS monitoring can safely be recommended to determine anesthetic depth under TIVA.

TERMINATED
Total Intravenous Anesthesia (TIVA) vs. Inhaled Anesthesia for Endoscopic Sinus Surgery.
Description

The purpose of this study is to compare total intravenous anesthesia to inhaled anesthesia in endoscopic sinus surgery for chronic sinusitis. The investigators will compare bleeding during surgery, duration of surgery, blood flow to the nose and other parameters. The investigators hypothesize that total intravenous anesthesia decreases bleeding and improves the view during surgery.

WITHDRAWN
Intravenous Anesthesia Versus Anesthesia With Volatile Agents in Elective Craniotomy for Tumors
Description

If the anesthetic regimen can influence the serum level of inflammatory cytokines and if the levels of cytokines are related to the incidence of post operative complications, these complications may be a function of the anesthetic method. In an effort to find the best anesthetic regimen for patients undergoing craniotomy for intracranial tumors, the researchers will compare the effect of volatile anesthetic with that of total intravenous anesthesia (TIVA) on cytokine levels. The researchers will also compare the composite incidence of some common major post-operative complications after craniotomy for intracranial malignancy.

Conditions
COMPLETED
Combination of Magnesium and Lidocaine for the Pretreatment of Pain That is Caused by the Injection of Propofol
Description

Since the introduction of propofol into routine anesthesia practice, the phenomena of pain on injection has plagued anesthesia providers. Propofol, an unstable phenol, triggers the release of bradykinin on injection. This release causes a painful burning sensation in the patient at the site of injection. Anesthesia providers have attempted a large number of remedies to prevent this pain on injection. Previously explored ideas include injecting propofol into larger veins, warming of the hand with hot packs, and intravenous pretreatment with numerous other medications. Currently, pretreatment with lidocaine is commonly administered to prevent propofol injection pain. No studies to date have looked at the combination of lidocaine and magnesium in a single syringe for the pretreatment of pain on injection caused by propofol. In addition, the administration protocols that have been studied thus far do not mirror clinical practice at the University of Wisconsin. The investigators propose studying the use of magnesium and lidocaine in a single syringe for pretreatment of propofol related pain on injection.

RECRUITING
Inhalational Anesthesia vs TIVA in Endoscopic Tympanoplasty
Description

This study aims to prospectively compare surgical field quality and intraoperative blood loss between general inhalational anesthesia to total intravenous anesthesia (TIVA) alone in subjects undergoing endoscopic ear surgery. A secondary objective is to compare rates of emergence delirium and total recovery time between the two groups.

COMPLETED
Markers of Alzheimers Disease and Cognitive Outcomes After Perioperative Care
Description

This study will examine the hypothesis that changes in the cognition (i.e. thinking and memory) after anesthesia and surgery are correlated with changes in markers of Alzheimers Disease in the fluid around the brain and spinal cord (i.e. cerebrospinal fluid, or CSF), and/or changes in brain connectivity. The investigators will also examine whether different types of anesthesia have different effects on these CSF markers of Alzheimers disease, or different effects on thinking and memory after anesthesia and surgery, or differential effects on the correlation between cognitive changes and CSF marker changes.

COMPLETED
Remifentanil Propofol Infusion in Pediatric Spinal Surgery
Description

Total intravenous anesthesia(TIVA) is a commonly used anesthetic technique. Although TIVA can be accomplished with a variety of drug combinations, infusions of Propofol and Remifentanil are often used with dosage adjusted manually by the anesthesia provider.The pharmacokinetics of these drugs are well understood, and that knowledge has led to the development of computer controlled infusion pumps that can administer the drugs based upon pharmacokinetic models. Computer controlled infusion schemes automatically adjust the drug administration based upon pharmacokinetic models which typically dictate a tapering infusion scheme. When one considers the dosage of a computer controlled infusion it is obvious that manually imitating a similar scheme may be difficult.This study will evaluate manually controlled infusion schemes using the models built into the Applied Medical Visualizations (Medvis) display and compare the manual dosage schemes to the predicted effect site concentrations and pharmacodynamic effect.

Conditions
COMPLETED
Susceptibility of Motor-Evoked Potentials to Varying Targeted Blood Levels of Dexmedetomidine
Description

Reduction of the spinal cord injuries during scoliosis surgery is a major goal of the anesthesia and surgical team. Despite improvement in scoliosis surgery over the years, the development of neurological deficits remains the most feared complication of spine surgery. During scoliosis surgery it is very important to monitor the spinal cord to detect spinal cord injury with surgical manipulation. Continuous or intermittent intraoperative electrophysiological monitoring (neuron-monitoring) is used routinely during these procedures to provide the surgeon with information concerning the integrity of neurological structures at risk. All neuron-monitoring modalities are affected by the anesthetic regimen used. Of the various intravenous anesthetic drugs, the combination of propofol, remifentanil and dexmedetomidine appear to impact neuron-monitoring the least. The current anesthetic practice is to use the three drugs in combination at doses that do not depress the signals but there is no data relating targeted dexmedetomidine and propofol blood levels to neuron-monitoring signals. The lack of data results in wide variability in dosing with consequent variability in patient response. Hypothesis: Clinically relevant blood levels of dexmedetomidine will affect the amplitude of transcranial motor-evoked potentials (TcMEP) either independently or by interaction with propofol in a dose dependent manner.

Conditions
TERMINATED
Intravenous Versus Inhalational Anesthesia in Parkinson's Disease
Description

Parkinson's disease is a common progressive degenerative disease affecting 3% of all patients over the age of 65. Given their age and frailty, these patients frequently require surgical procedures with general anesthesia. However, after surgery, patients with Parkinson's disease have longer hospital stays and a greater chance of not returning to independent living compared to age-matched controls (Berman MF, unpublished data). In part, this is due to a higher rate of post-operative delirium, which had an incidence of 60% in this population in one study. There is anecdotal evidence from neurologists specializing in movement disorder suggesting that there is also significant deterioration in parkinsonian motor symptoms and cognition lasting for months or years following surgery and anesthesia. The basis for this deterioration is unknown. We hypothesize that these problems are caused by particular medications used during inhaled anesthesia for surgical procedures.

UNKNOWN
Evaluation of Second Esmarch Application on Intravenous Regional Anesthesia Effectiveness
Description

Intravenous regional anesthesia is a commonly used technique in the outpatient setting for short hand and upper extremity cases, such as carpal tunnel release or trigger finger release. The technique requires a tourniquet, Esmarch bandage, an intravenous line, and lidocaine. It can be performed and learned easily. The technique is safe and easy to perform, and it provides adequate anesthesia for short cases; however, there are still some cases in which adequate anesthesia is not achieved. One of the possible reasons for failure is that the local anesthetic (lidocaine) does not properly exit the veins to reach the interstitial space (where many nerves are located) to provide the nerve block. In this study, the investigators hypothesize that after application of lidocaine to the intravenous system, application of external pressure through the skin will facilitate tissue penetration and improve the block. The only research procedure being done is a re-application of the Esmarch bandage; all other procedures are Standard of Care.

COMPLETED
Cognitive Effects of Inhalational Versus Intravenous General Anesthesia in the Elderly
Description

The purpose of this research is to determine if post-operative cognition will be better if the general anesthesia for surgery is done with an inhaled (gas through a breathing tube) or intravenous (medicine injected in the IV) general anesthetic technique.

COMPLETED
Virtual Reality in the Operating Room
Description

This is a randomized, controlled trial designed to investigate whether the use of virtual reality immersive relaxation during hand/arm operations can allow for a relaxing operating room experience for patients while potentially reducing anesthesia requirements.

RECRUITING
Does Style of Pre-sedation Instructions Improve Patient Outcomes in Ambulatory Anesthesia for Oral and Maxillofacial Surgery?
Description

This randomized controlled trial aims to evaluate the impact of a brief guided visualization exercise on anesthesia-related outcomes in oral and maxillofacial surgery in patients scheduled for ambulatory anesthesia in the oral and maxillofacial surgery clinic. Researchers will compare these patients, who will receive the guided visualization exercise in addition to standardized pre-operative instructions, to patients who will only receive the standardized pre-operative instructions. The following outcomes will be measured for both groups: * A seven-point Anesthesia Experience Survey * Face-Legs-Activity-Cry-Consolability (FLACC) scores at three points in time during the anesthetic - during local anesthesia, during surgery, and fifteen minutes after surgery has concluded * Amount of medications used during the sedation * Length of sedation

RECRUITING
Total Intravenous Versus Inhalational Anesthesia- A Geriatric Anesthesia Study
Description

Traditionally, general anesthesia is maintained with inhalational anesthesia (GAS), but there is a gap in knowledge regarding whether intravenous anesthesia (IV) can prevent deleterious postoperative outcomes in the geriatric surgical population. The goal of this clinical trial is to determine whether intravenous anesthesia (IV) leads to a decreased incidence of postoperative delirium (POD), postoperative cognitive dysfunction (POCD), and functional decline, and improved patient-reported outcomes (PROs) in older adults undergoing non-cardiac surgery when compared to the standard inhalational anesthesia (GAS). This single-center, 1:1 randomized, double-blind (patient \& outcome assessor) clinical trial will compare inhalational vs. intravenous anesthesia on POD, POCD, functional status, patient-reported outcomes (PROs), and blood-based biomarkers in older patients undergoing elective, inpatient, non-cardiac surgery. Upon enrollment, 260 women and men ≥ 70 years undergoing elective noncardiac surgery under general anesthesia will be randomized to 2 groups: TIVA or GAS.

COMPLETED
Nitrous Oxide Versus Intravenous Sedation for Anesthesia
Description

This study is a multi-site, double-blinded, randomized, non-inferiority clinical trial of inhaled nitrous oxide with oxygen (N2O/O2) versus intravenous (IV) sedation, with fentanyl and midazolam, for pain management in adult women having a pregnancy termination procedure between 12 and 16 weeks gestational age.

TERMINATED
Intravenous Sedation Versus General Anesthesia in Patients Undergoing Minor Gynecologic Surgery
Description

The use of deep sedation may improve the quality of recovery of patients undergoing minor gynecologic procedures. These patients may also have shorter hospital stays and potentially lower healthcare costs. Additionally, the use of deep sedation for second trimester pregnancy termination may be associated with less bleeding, a smaller decrease in perioperative hemoglobin and better quality of recovery.

COMPLETED
Perioperative Intravenous Lidocaine or Epidural Anesthesia on Outcomes in Complex Spine Surgery
Description

The purpose of this study is determine if epidural anesthesia administered after surgery or lidocaine administered during surgery will decrease inflammation after spinal surgery and decrease the need for post operative pain medication compared to intravenous patient controlled analgesia. Participants undergoing spine surgery will be randomized into one of two groups; - A.) General Anesthesia and postoperative Patient Controlled Analgesia and placebo IV infusion. B.) General Anesthesia plus perioperative intravenous lidocaine infusion, and post operative Patient Controlled Analgesia.

Conditions
COMPLETED
Jet Injection of 1% Buffered Lidocaine Versus Topical ELA-Max for Anesthesia Prior to Intravenous (IV) Catheterization in Children
Description

This trial is a comparison of the anesthetic effectiveness of J-Tip needle-free jet injection of 1% buffered lidocaine to the anesthetic effectiveness of topical 4% ELA-Max for peripheral intravenous catheter (PIV) insertion. The researchers hypothesize that the jet injection of lidocaine will provide superior anesthesia to the ELA-Max prior to PIV insertion.

Conditions
COMPLETED
Local Anesthetics for Pain Reduction Prior to IV Line Placement
Description

The purpose of this study is to compare the pain level felt by patients when receiving placement of a peripheral intravenous catheter (IV line) following the administration of a local anesthetic. The local anesthetics tested will be lidocaine, buffered lidocaine, and bacteriostatic normal saline. Lidocaine is commonly used as a premedication for reducing the pain upon insertion of peripheral IV lines. However, due to its acidic nature, the lidocaine itself may cause pain upon administration. To help counter this discomfort, pharmacies can "buffer" the lidocaine using sodium bicarbonate, which increases the pH to a neutral value, resulting in less pain. Bacteriostatic normal saline has also been used for local anesthesia with peripheral IV placement, particularly in patients with a lidocaine allergy, as it contains benzyl alcohol which acts as a local anesthetic. There are minimal reports from the literature that directly compare patient reported pain of all three agents to one another, although studies do exist that have compared buffered lidocaine versus lidocaine and buffered lidocaine versus bacteriostatic normal saline. To address this comparison gap, the following research questions need to be asked: which anesthetic agent is the superior premedication for reducing the amount of pain upon administration of the local anesthetic itself and for the pain associated with the peripheral insertion of the catheter? The hypothesis of the investigators is that there is not a significant difference in the degree of pain scales between the anesthetic agents to justify the pharmacoeconomic costs associated with compounding buffered lidocaine. The primary outcome measured in this study will be the level of pain reported by the patient upon administration of the local anesthetic and upon insertion of the peripheral intravenous catheter. A secondary outcome includes a pharmacoeconomic analysis that will look specifically at the cost-savings of using one agent over the other and will take into account the daily time allocated to pharmacy technicians and pharmacists for compounding and verifying buffered lidocaine.

RECRUITING
Trajectories of Recovery After Intravenous Propofol Versus Inhaled VolatilE Anesthesia Trial
Description

The investigators will conduct a 12,500-patient randomized multi-center trial to determine (i) which general anesthesia technique yields superior patient recovery experiences in any of three surgical categories ((a) major inpatient surgery, (b) minor inpatient surgery, (c) outpatient surgery) and (ii) whether TIVA confers no more than a small (0.2 %) increased risk of intraoperative awareness than INVA in patients undergoing both outpatient and inpatient surgeries

COMPLETED
Comparison of Two Intravenous Drug Combinations for Ambulatory Oral & Maxillofacial Surgery
Description

The purpose of this pilot study was to compare two commonly employed intravenous drug combinations; I) nitrous oxide, midazolam, fentanyl, and ketamine and II) the same combination with substitution of propofol for ketamine, for use during wisdom teeth extraction. Measures of recovery, amnesia testing 20 minutes after induction and after completion of recovery tests, patient satisfaction, and surgeon satisfaction will be evaluated. The data from this pilot study will be used to obtain preliminary estimates of effect sizes and to select primary and secondary endpoints for the design of a larger scale and more definitive trial of the two anesthetic approaches.