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OpenTrials
Completed

NCT Number: NCT05975385

Acupuncture for Prevention of Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy

The purpose is to find out if intraoperative acupuncture performed by needling PC 6 and LI4 point bilaterally, and Yin Tang point will help reduce the incidence postoperative nausea and vomiting in patients undergoing laparoscopic cholecystectomy when added to a prophylactic regimen consisting of ondansetron and dexamethasone. The hypothesis is that the addition of this acupuncture treatment to ondansetron and dexamethasone given for prophylaxis will help reduce the incidence of postoperative nausea and vomiting in patients undergoing laparoscopic cholecystectomy when compared to patients receiving ondansetron and dexamethasone without acupuncture.

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Key information

Conditions

Cholecystitis, Acute Biliary Tract Diseases Cholecystitis Cholelithiasis Digestive System Diseases Gallbladder Diseases Nausea Nausea, Postoperative Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Nausea and Vomiting Signs and Symptoms Signs and Symptoms, Digestive Vomiting Vomiting, Postoperative

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ben Taub Hospital

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient ages 18-64
  • American Society of Anesthesiology Physical Status I, II or III
  • Patients scheduled to undergo laparoscopic cholecystectomy at Harris Health System Ben Taub Hospital

Exclusion criteria

  • Scheduled open cholecystectomy - excluded due to increased levels of pain in open procedures
  • Renal dysfunction (Serum Cr > 1.2) - excluded due to potential altered metabolism of anesthetic and perioperative medications
  • Allergy to any of the standard anesthetic agents
  • Patient inability to properly communicate with investigators (language barrier, dementia, delirium, psychiatric disorder)
  • Patient or surgeon refusal

Treatment and study plan

acupuncture

Device

Acupuncture at points points PC 6 bilaterally, LI 4 bilaterally, and Yin Tang

Primary outcomes

  1. Incidence of postoperative nausea and vomiting

    Time frame: Postoperative: 0-1 hours, 1-6 hours, 6-12 hours, 12-24 hours

    Incidence of nausea and vomiting after surgery

Secondary outcomes

  1. Postoperative pain

    Time frame: 24 hours

    Pain on scale 1-10 measured on arrival to PACU, discharge from PACU and at 24 hours post surgery

  2. Total opioids used

    Time frame: 24 hours

    Total opioid given, converted to oral morphine equivalents

Sponsors and collaborators

Lead sponsor

Baylor College of Medicine

Other

Registry information

Official study title

Acupuncture For Prevention Of Postoperative Nausea And Vomiting In Patients Undergoing Laparoscopic Cholecystectomy - A Randomized Controlled Trial

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Aug 3, 2023
Registry last updated
Mar 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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