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Acupuncture for Postoperative Nausea and Vomiting

N/A

Recruiting

Research Sponsored by Baylor College of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

American Society of Anesthesiology Physical Status I, II or III

Patients scheduled to undergo laparoscopic cholecystectomy at Harris Health System Ben Taub Hospital

Timeline

Screening 3 weeks

Treatment Varies

Follow Up postoperative: 0-1 hours, 1-6 hours, 6-12 hours, 12-24 hours

Awards & highlights

Study Summary

This trial tests if acupuncture reduces nausea/vomiting after laparoscopic surgery when combined with drugs.

Who is the study for?

This trial is for patients aged 18-64 who are scheduled for laparoscopic gallbladder removal at Ben Taub Hospital and have a moderate risk of complications from surgery. It's not for those with communication barriers, mental health issues, planned open surgery, kidney problems or allergies to anesthesia.Check my eligibility

What is being tested?

The study tests if acupuncture on specific points during surgery can reduce nausea and vomiting after the operation. This is in addition to standard drugs given for these symptoms. Patients will be compared to see if acupuncture offers extra benefits over medication alone.See study design

What are the potential side effects?

Acupuncture may cause minor side effects like slight bleeding or bruising where needles are inserted, dizziness, or rare allergic reactions. The procedure is generally considered safe when performed by trained professionals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My overall health is good to moderately impaired.

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I am scheduled for a gallbladder removal surgery at Ben Taub Hospital.

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I am between 18 and 64 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ postoperative: 0-1 hours, 1-6 hours, 6-12 hours, 12-24 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~postoperative: 0-1 hours, 1-6 hours, 6-12 hours, 12-24 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and postoperative: 0-1 hours, 1-6 hours, 6-12 hours, 12-24 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of postoperative nausea and vomiting

Secondary outcome measures

Postoperative pain

Total opioids used

Side effects data

From 2013 Phase 1 & 2 trial • 104 Patients • NCT01305811

Serious unexpected

Pain on needling

100%

80%

60%

40%

20%

Study treatment Arm

Bi-Weekly Acupuncture

Wait List

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: AcupunctureExperimental Treatment1 Intervention

Group Acupuncture: Points PC 6 bilaterally, LI 4 bilaterally, and Yin Tang will be needled using Seirin L Type 0.25 X 40 mm needles. MH 6 is located 2 cun (a traditional Chinese unit of length) above the wrist crease in between the tendons of palmaris longus and flexor carpi radialis. LI 4 is in the middle of first and second metacarpal bones. Yin Tang is located between the eyebrows. All needles will be removed once skin closure begins, and before emergence and extubation.

Group II: ControlActive Control1 Intervention

No acupuncture treatment provided

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Acupuncture

2011

Completed Phase 3

~1240

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Baylor College of MedicineLead Sponsor

1,001 Previous Clinical Trials

6,002,112 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any open positions available to enrollees for this experiment?

"Affirmative, according to the information available on clinicaltrials.gov this trial is searching for participants. It was first posted on October 9th 2023 and has been updated since then with a target of 300 patients being admitted from 1 location."

Answered by AI

Does this trial extend to individuals over 45 years of age?

"This clinical trial has an age range of 18 to 64, encompassing the eligibility requirements."

Answered by AI

How many participants are currently being recruited for this trial?

"Affirmative. According to the data available on clinicaltrials.gov, this medical experiment is currently sourcing volunteers. It was first posted on October 9th 2023 and has been updated recently as of that same date. 300 participants are being recruited from a single location."

Answered by AI

Who meets the prerequisites for taking part in this experiment?

"The medical trial seeks 300 individuals aged 18-64 who are diagnosed with gallstones and have an American Society of Anesthesiology Physical Status I, II or III. All participants must be scheduled to receive laparoscopic cholecystectomy at Harris Health System Ben Taub Hospital."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Acupuncture for Prevention of Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy

Jaime Ortiz 2023. "Acupuncture for Prevention of Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05975385.