RECRUITING

Effect of TEAS on PONV After Spinal Surgery

Conditions

PONV Transcutaneous Electrical Acupoint Stimulation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The proposed research will utilize electroacupuncture, a type of needleless acupuncture that uses electrostimulation, in a randomized, double blind study, to evaluate the incidence of post-operative nausea and vomiting (PONV) in patients undergoing spinal surgeries with the transcutaneous electrical acupoint stimulation (TEAS) compared to patients without TEAS.

Official Title

The Effect of Transcutaneous Electric Acupoint Stimulation on Post-operative Nausea and Vomiting After Spinal Surgery

Quick Facts

Study Start:2018-08-01

Study Completion:2024-12-20

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03187535

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Male and female patients , 18 or older * American Society of Anesthesiologists (ASA) classification I or II or III * Undergoing elective spinal surgery expected to last no more than four hours (from induction of anesthesia to extubation). * Capable and willing to consent	* Neuraxial (intrathecal or epidural) block * Significant ongoing history of vestibular disease or dizziness * Nausea or vomiting within 24 hours prior to surgery, use of antiemetic or emetogenic drugs within 3 days of surgery * Documented alcohol or substance abuse within 3 months before the surgery * Limb abnormalities such as burn and amputation. * Poorly controlled diabetes mellitus (fasting plasma glucose \>126 mg/dL or \<70 mg/dL) * Implantation of metal/electrical devices, such as nerve stimulator, cardiac pacemaker, cardioverter, defibrillator and internal hearing aids * Rash, local infection, keloid, any dermatologic condition that could interfere with the acupoint stimulation area * Documented alcohol or substance abuse within 3 months before surgery * Presence of clinically diagnosed major psychiatric condition such as bipolar disorder, uncontrolled major depression, or schizophrenia * Chemotherapy or radiation therapy within 7 days before surgery * Investigational product use within 3 months prior surgery * Any condition, which in the opinion of the investigator would make subject ineligible for participation in the study (history of unstable cardiovascular, pulmonary, renal, hepatic, seizures) * Special population (prisoners, pregnant and lactating women)

Inclusion Criteria

Exclusion Criteria

* Male and female patients , 18 or older
* American Society of Anesthesiologists (ASA) classification I or II or III
* Undergoing elective spinal surgery expected to last no more than four hours (from induction of anesthesia to extubation).
* Capable and willing to consent

* Neuraxial (intrathecal or epidural) block
* Significant ongoing history of vestibular disease or dizziness
* Nausea or vomiting within 24 hours prior to surgery, use of antiemetic or emetogenic drugs within 3 days of surgery
* Documented alcohol or substance abuse within 3 months before the surgery
* Limb abnormalities such as burn and amputation.
* Poorly controlled diabetes mellitus (fasting plasma glucose \>126 mg/dL or \<70 mg/dL)
* Implantation of metal/electrical devices, such as nerve stimulator, cardiac pacemaker, cardioverter, defibrillator and internal hearing aids
* Rash, local infection, keloid, any dermatologic condition that could interfere with the acupoint stimulation area
* Documented alcohol or substance abuse within 3 months before surgery
* Presence of clinically diagnosed major psychiatric condition such as bipolar disorder, uncontrolled major depression, or schizophrenia
* Chemotherapy or radiation therapy within 7 days before surgery
* Investigational product use within 3 months prior surgery
* Any condition, which in the opinion of the investigator would make subject ineligible for participation in the study (history of unstable cardiovascular, pulmonary, renal, hepatic, seizures)
* Special population (prisoners, pregnant and lactating women)

Contacts and Locations

Study Contact

Juan Fiorda, MD, PhD

CONTACT

614-293-3559

juan.fiorda@osumc.edu

Alberto Uribe, MD

CONTACT

614-293-3559

alberto.uribe@osumc.edu

Principal Investigator

Sergio Bergese, MD

PRINCIPAL_INVESTIGATOR

The Ohio State University Wexner Medical Center

Study Locations (Sites)

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210

United States

Collaborators and Investigators

Sponsor: Jyoti Pandya

Sergio Bergese, MD, PRINCIPAL_INVESTIGATOR, The Ohio State University Wexner Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-08-01

Study Completion Date2024-12-20

Study Record Updates

Study Start Date2018-08-01

Study Completion Date2024-12-20

Terms related to this study

Keywords Provided by Researchers

Transcutaneous Electrical Acupoint Stimulation

Additional Relevant MeSH Terms

PONV