Treatment Trials

40 Clinical Trials for Various Conditions

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COMPLETED
Real-time Decision Support for Postoperative Nausea and Vomiting (PONV) Prophylaxis
Description

The purpose of this study is to determine how automated recommendations are best presented to optimize the adherence to guidelines on prophylaxis for nausea and vomiting after surgery.

COMPLETED
A Study of Vestipitant (GW597599) in the Treatment of Breakthrough Postoperative Nausea and Vomiting (PONV)
Description

This study will evaluate single IV doses of Vestipitant (GW597599) compared to 4 mg IV ondansetron for treating breakthrough postoperative nausea and vomiting (PONV) after failure of PONV prophylaxis with a regimen that includes 4 mg IV ondansetron.

COMPLETED
Pilot Study to Assess Palonosetron Versus Ondansetron as Rescue Medication in Subjects That Develop Postoperative Nausea and Vomiting (PONV) in the Postanesthesia Care Unit (PACU)
Description

The purpose of this study is to investigate palonosetron versus ondansetron as rescue medication in subjects that develop postoperative nausea and vomiting (PONV) in the Postanaesthesia Care Unit (PACU).

UNKNOWN
Oral Aprepitant and Lower Dose Dexamethasone Versus Aprepitant Alone for Preventing Postoperative Nausea and Vomiting (PONV) After Elective Laparoscopic Surgeries
Description

The combination of aprepitant and lower dose dexamethasone is superior to aprepitant alone with respect to the proportion of patients with a complete response (no vomiting and no use of rescue therapy) during 24 hours after the placement of last suture/staple.

Conditions
COMPLETED
Prevention of Postoperative Nausea and Vomiting (PONV) in Surgical Patients
Description

This study will compare two different drug regimens (oral dronabinol versus intravenous ondanseteron) for the prevention of post-operative nausea and vomiting (PONV).

COMPLETED
Implementing a Nurse-Driven Aromatherapy Protocol to Decrease the Effect of Postoperative Nausea and Vomiting
Description

This is a quality improvement project that aims to assess the effect of nurse-driven administration of essential oil aromatherapy on postoperative nausea and vomiting (PONV) in patients while in the post-anesthesia care unit (PACU) after general anesthesia.

COMPLETED
A Study of TAK-951 to Stop Adults Getting Nausea and Vomiting After Planned Surgery
Description

Some adults are at a higher risk of feeling sick (nausea) or being sick (vomiting) after they have surgery. In this study, these adults will have planned surgery. The main aim of this study is to learn if TAK-951 stops these adults from getting nausea or vomiting after surgery. This will be compared with another medicine called ondansetron. Another aim is to check for side effects from the study medicines. Before surgery, the study doctor will check who can take part in this study. Those who can take part will be picked for either Treatment Group A or Treatment Group B by chance. * Treatment Group A: Just before surgery, participants will receive a placebo slowly through a vein (infusion). Just before the end of the surgery, they will receive TAK-951 as an injection under the skin. * Treatment Group B: Just before surgery, participants will receive ondansetron slowly through a vein (infusion). Just before the end of the surgery, they will receive a placebo as an injection under the skin. In this study, a placebo will look like TAK-951 but will not have any medicine in it. Participants will not know which study medicines they received, or in which order, nor will their study doctors or surgeons. This is to help make sure the results are more reliable. Participants will stay in the hospital for 24 hours after their surgery so that the study doctors can check for nausea and vomiting. The study doctors will also check for side effects from the study medicines. Participants will visit the hospital for a check-up 14 days later.

COMPLETED
Aprepitant Versus Ondansetron in Preoperative Triple-therapy Treatment of Nausea and Vomiting
Description

This study is being done to determine the efficacies of two preventative drug combinations for postoperative nausea and vomiting in patients undergoing neurosurgery. The aim of this study is to compare the efficacy of using aprepitant instead of ondansetron in combination with dexamethasone and promethazine for post-operative nausea and vomiting prophylaxis. By completing this comparison study investigators will determine the most efficacious drug combination which will allow us to enhance the overall comfort and satisfaction of neurosurgical patients in the immediate postoperative period.

COMPLETED
Casopitant (Oral) And ZOFRAN To Prevent Postoperative Nausea And Vomiting In Women
Description

This study is being conducted to see if adding GW679769 (casopitant) to ZOFRAN will significantly decrease the number of patients who experience nausea and vomiting after surgery.

COMPLETED
The Effects of Hypercapnia, Supplemental Oxygen, and Dexamethasone on Surgical Wound Infection
Description

The investigators will test the hypotheses that mild hypercapnia and supplemental oxygen reduce wound infection risk in patients undergoing colon resection. The investigators will simultaneously test the hypothesis that low-dose dexamethasone (a common treatment for postoperative nausea and vomiting) does not increase infection risk.

RECRUITING
Study of Intravenous Amisulpride for Prophylaxis of Post-operative Nausea and Vomiting (PONV) in Pediatric Patients
Description

Randomized, double-blind, pediatric trial of amisulpride for prophylaxis of post operative nausea and vomiting

COMPLETED
Dose-ranging Study of APD405 in Post-operative Nausea and Vomiting (PONV)
Description

To assess the efficacy and safety of different doses of APD405 in the prevention of post-operative nausea and vomiting (PONV) in adult patients at moderate to high-risk of PONV. Patients must be undergoing elective surgery under general anaesthesia (hysterectomy (any surgical technique), cholecystectomy (any surgical technique) or "other" elective surgery scheduled to last at least one hour from induction of anaesthesia), requiring at least one overnight stay in hospital, and have at least 2 of the following risk factors for PONV: Past history of PONV and/or motion sickness; Non-smoking status; Female gender; Planned opiate use for post-operative analgesia.

COMPLETED
Intraoperative Acupoint Stimulation to Prevent Post-Operative Nausea and Vomiting (PONV)
Description

The goal of this clinical research study is to learn if light electrical stimulation to the wrist area during surgery is feasible in women having breast surgery.

COMPLETED
Decreasing the Incidence of Post-Operative Nausea and Vomiting (PONV) in Bariatric Patients
Description

The study drug, Aprepitant, is currently used to control chemotherapy induced nausea and vomiting and is also approved for post-operative nausea and vomiting. The investigators' evaluation of it in morbidly obese patients will demonstrate its ability to control nausea and vomiting post-operatively in this subset of patients.

Conditions
COMPLETED
A Study of Kytril (Granisetron) in the Prevention of Post-Operative Nausea and Vomiting (PONV) in Pediatric Subjects Undergoing Tonsillectomy or Adenotonsillectomy
Description

This 2 arm study will evaluate the efficacy and safety of a single intravenous injection of Kytril in preventing postoperative nausea and vomiting (PONV) in children. Patients will be randomized to receive a single dose of either 20 micrograms or 40 micrograms Kytril intravenously (iv) 15 minutes prior to the end of surgery with general anesthesia for tonsillectomy or adenotonsillectomy. The anticipated time on study treatment is \<3 months, and the planned sample size was 170 patients.

RECRUITING
Opioid Sparing Anesthesia Care for Pediatric Patients Having Tonsil Surgery
Description

This is a prospective, randomized, controlled, non-inferiority study of patients undergoing tonsil surgeries at Boston Children's Hospital Waltham. The overall aim is to evaluate the efficacy of an opioid anesthetic plan (morphine, ketorolac, and acetaminophen versus an opioid sparing anesthetic plan (dexmedetomidine, ketorolac and acetaminophen) for perioperative analgesia and recovery time in patients undergoing tonsillectomies and tonsillotomies at Boston Children's Hospital Waltham. Secondary measures include rescue opioids administered in post-anesthesia care unit (PACU), re-operation secondary to bleeding, emergence delirium, post-operative nausea and vomiting, intraoperative hemodynamics, intraoperative vasopressor administration, and length of procedure.

COMPLETED
Comparison of Oral Aprepitant and Transdermal Scopolamine for Preventing Postoperative Nausea and Vomiting
Description

Recent evidence suggests multiple drug therapy is superior to single agents. The study compares the incidence of nausea, vomiting, need for rescue medication, prolonged PACU time, and unplanned hospital admission in patients with high risk for PONV treated with oral aprepitant with or without transdermal scopolamine preoperatively.

Conditions
WITHDRAWN
Transdermal Nicotine in Female Patients at High Risk for Post Operative Nausea and/or Vomiting (PONV)
Description

The purpose of this study is to see if the nicotine patch reduces post operative nausea and/or vomiting (PONV) among non-smoking patients who are at high risk of PONV.

COMPLETED
Exogenous Sex Hormones and PONV
Description

This study aims to investigate the rates of postoperative nausea and vomiting in transgender patients on hormone therapy compared to cisgender patients undergoing the same procedures (hysterectomy, orchiectomy, augmentation mammoplasty).

COMPLETED
Acupuncture and Acupressure for Postoperative Nausea and Vomiting in Children Undergoing Outpatient Middle Ear Surgery
Description

The specific aim of this study is to determine the incidence of post-operative nausea and vomiting (PONV) in the pediatric population undergoing outpatient middle ear surgery.

COMPLETED
Guanfacine for PONV and Pain After Sinus Surgery
Description

Postoperative nausea and vomiting (PONV) and pain are the most common causes of Post Anesthesia Care Unit (PACU) discharge delay, with untreated PONV occurring in 20-30% of post-surgical patients. The effect of guanfacine (GF) administration on pain and nausea scores will be assessed with two groups. One group will receive 1 mg of GF to take orally and the other group will receive a similar appearing placebo (containing no drug) to take orally.

COMPLETED
Study of APD421 as PONV Treatment (Prior Prophylaxis)
Description

Double-blind, randomised, parallel-group, placebo-controlled, adaptive, seamless, dose-selecting study to compare the efficacy of APD421 to placebo as treatment of established PONV, in patients who have had prior PONV prophylaxis.

COMPLETED
Granisetron Transdermal Patch for Prevention of Postoperative Nausea and Vomiting
Description

The objective of the study is to evaluate the efficacy and safety of adding transdermal preparation of granisetron (Sancuso ®) to the current postoperative nausea and vomiting (PONV) standard prophylaxis regimen with dexamethasone and ondansetron in patients with the previous history of severe, particularly delayed and/or post-discharge, PONV and undergoing surgical procedure under general anesthesia. The specific aims of the study include: 1. efficacy of the investigated therapy in prevention of PONV up to 120 hours after surgery 2. incidence and seriousness of the observed side effects 3. ability of patients to self-administer preoperatively and maintain the investigated patch during the perioperative period 4. level of satisfaction with the preoperative PONV prophylaxis.

COMPLETED
Study of APD421 as PONV Treatment (no Prior Prophylaxis)
Description

Double-blind, randomised, parallel-group, placebo-controlled, adaptive, seamless, dose-selecting study to compare the efficacy of APD421 to placebo as treatment of established PONV, in patients who have not had prior PONV prophylaxis.

COMPLETED
Phase II Dose-ranging Study of APD421 in PONV
Description

To assess the efficacy and safety of different doses of APD421 in the prevention of post-operative nausea and vomiting (PONV) in adult patients at moderate to high-risk of PONV. Patients must be undergoing elective surgery under general anaesthesia (hysterectomy (any surgical technique), cholecystectomy (any surgical technique) or "other" elective surgery scheduled to last at least one hour from induction of anaesthesia), requiring at least one overnight stay in hospital, and have at least 2 of the following risk factors for PONV: Past history of PONV and/or motion sickness; Non-smoking status; Female gender; Planned opiate use for post-operative analgesia.

COMPLETED
Effect of Intraoperative Anesthetic Management on Postoperative Nausea and Vomiting in Bariatric Surgery
Description

Morbidly obese patients are at high risk for Postoperative Nausea and Vomiting (PONV) after surgery and general anesthesia. The results of our observational study indicate that 42.7% of patients require medication to treat PONV in the first 24 hours after bariatric surgery despite our aggressive perioperative approach with triple prophylaxis. Common risk factors for PONV are the use of intraoperative narcotics and anesthetic gases. Preliminary results of multimodal postoperative analgesia in the first 24 hours lead to a reduction of narcotic consumption, desaturations and use of antiemetic medication. Our study hypothesis is that different types of anesthetics reduce PONV further. Patient would be randomly assigned to receive either our current intraoperative management or a narcotic free, total intravenous general anesthetic (TIVA). The investigators hope to improve patients' satisfaction by reducing PONV in the postoperative period.

COMPLETED
Combination Antiemetic Regimen for Prevention of PONV in Breast Surgery Patients
Description

The purpose of this study is to compare the efficacy of the use of oral aprepitant in combination with intravenous ondansetron and dexamethasone with the efficacy provided by the use of oral aprepitant and dexamethasone for preventing vomiting during the first 24-48 hours after breast surgery.

COMPLETED
Aprepitant With Dexamethasone Versus Ondansetron With Dexamethasone for PONV Prophylaxis in Patients Having Craniotomy
Description

We hypothesize that the combination of aprepitant with dexamethasone will provide significantly improved prophylaxis against Postoperative nausea and vomiting compared with the combination of ondansetron and dexamethasone, in patients undergoing craniotomy under general anesthesia.

WITHDRAWN
Aprepitant PO vs Ondansetron IV for Prevention of Postoperative Nausea and Vomiting
Description

Postoperative nausea and vomiting (PONV) persists as one of the more common complications of surgery. Although rarely life-threatening, it is the postoperative outcome that is most unfavorable to patients, even more undesirable than pain. Orthognathic surgery corrects conditions of the jaws and face related to structure, growth, sleep apnea, bad bite, or congenital malformations. The bones of the face and jaws are cut and placed in a new position. There is a high rate of PONV in orthognathic surgery (56%). It is particularly challenging to the patient as their jaws are kept closed together with wires or elastic bands. Nausea in a patient with restricted mouth opening can be psychologically unnerving and puts them at risk for fluid in their lungs. Gan and colleagues showed a higher efficacy of aprepitant over ondansetron in preventing PONV and nausea severity after open abdominal surgery. From this study, the FDA approved the use of aprepitant for PONV prevention in patients \>18 years of age. Gan suggested further investigation in different populations. Our randomized, double-blind, prospective study will compare the efficacy of aprepitant PO versus ondansetron IV in a high risk setting for PONV: adolescents undergoing orthognathic surgery. Our study will involve 200 consecutive, adolescent patients (ages 15-25) who will undergo at least a Le Fort 1 osteotomy (upper jaw surgery) under general anesthesia and require hospital admission for at least one night. We will exclude patients who are currently taking medications that have interactions with aprepitant (pimozide, terfenadine, astemizole, cisapride), those who have a known vomiting disorder such as bulimia, and those who have vomited for any reason within 24 hours of surgery. The procedure will be performed by 5 surgeons and general anesthesia will be administered by 3 anesthesiologists at one institution. A study coordinator, who will not be involved in the treatment, will create the randomization schedule in order to ensure blindness. The patients will be randomized to either of two groups: 1) aprepitant 40 mg PO 2) ondansetron 4 mg IV. Appropriate verbal and written consent will be obtained by the priniciple investigator or surgeon. On the day of the procedure, all patients will receive a pill (aprepitant or aprepitant placebo) at least 1 hour prior to induction of anesthesia and an IV infusion (ondansetron or saline) over 2-5 minutes prior to intubation. The timing and doses of medications will be consistent with manufacturer's recommendations. An established protocol will ensure every patient will receive the same anesthetic regiment. Patient's fluid status will be closely monitored and hydrated appropriately according to known fluid balance calculations. Efficacy will be assessed based on criteria set by Gan et al and will be based on the presence/absence of a vomiting episode, use of rescue medication and subjective evaluation of nausea. Patients will be monitored continuously in the PACU and on the hospital floor by the caring team (nurse, resident, anesthesiologist, surgeon) for any emetic episode or use of rescue therapy. An emetic episode is defined as an act of vomiting (oral expulsion of stomach contents) or retching (non-productive vomiting). Nausea will be assessed at intervals of 0, 2, 6, 24 hours after surgery with T0 being time of extubation. Patients will rate nausea on a 11-point verbal rating scale, with 0 being "not nausea" to 10 being "the worst nausea." Rescue medication will be offered if the patient has more than one episode of vomiting or retching, if the patient has nausea lasting longer than 15 minutes, or if the patient requests it for established nausea or vomiting.

COMPLETED
Aprepitant for PONV Prophylaxis in Outpatient Plastic Surgery
Description

Hypothesis: Aprepitant plus ondansetron is more effective than ondansetron plus placebo for prevention of postoperative emesis in patients at moderate-to-high risk for PONV for up to 48 hours after surgery. Specific Aim: To determine the incidence of PONV during the first 48 hours after surgery; in patients who have received aprepitant plus ondansetron versus ondansetron plus placebo for up to 48 hours after surgery.