Cholecystitis, AcuteNCT05975385
Acupuncture for Prevention of Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy
A study testing Acupuncture in people with Cholecystitis, Acute and Cholelithiasis, run by Baylor College of Medicine at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Cholecystitis, Acute, Cholelithiasis, Nausea, Postoperative
- What is being tested?
- Acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Oct 2023to 10 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acupuncture For Prevention Of Postoperative Nausea And Vomiting In Patients Undergoing Laparoscopic Cholecystectomy - A Randomized Controlled Trial
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.
- Conditions
- Cholecystitis, Acute, Cholelithiasis, Nausea, Postoperative, Vomiting, Postoperative, Pain, Postoperative
- Being tested
- Acupuncture
- Medical subject headings
- Cholecystitis, Acute, Cholelithiasis, Postoperative Nausea and Vomiting, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureDevice
Acupuncture at points points PC 6 bilaterally, LI 4 bilaterally, and Yin Tang
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture | Experimental | 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. Receives: Device: Acupuncture |
| Control | No intervention | No acupuncture treatment provided |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative nausea and vomiting
Incidence of nausea and vomiting after surgery
Measured: Postoperative: 0-1 hours, 1-6 hours, 6-12 hours, 12-24 hours
Secondary outcomes (2)
Postoperative pain
Pain on scale 1-10 measured on arrival to PACU, discharge from PACU and at 24 hours post surgery
Measured: 24 hours
Total opioids used
Total opioid given, converted to oral morphine equivalents
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2023
- Study start9 Oct 2023
- Primary completion16 Jan 2026
- Study completion10 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cholecystitis, AcuteStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial. Group 1 - Acupuncture Group 2 - No acupuncture
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jaime Ortiz, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05975385
- Sponsor's protocol ID
- H-53767
- Status last verified
- Jan 2026
- First submitted
- 26 Jul 2023
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture For Prevention Of Postoperative Nausea And Vomiting In Patients Undergoing Laparoscopic Cholecystectomy - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05975385
- Acronym / sponsor ID
- H-53767
- Conditions
- Cholecystitis, Acute, Cholelithiasis, Nausea, Postoperative, Vomiting, Postoperative, Pain, Postoperative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- 9 Oct 2023 (actual)
- Primary completion
- 16 Jan 2026 (actual)
- Study completion
- 10 Feb 2026 (actual)
- First posted
- 3 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial. Group 1 - Acupuncture Group 2 - No acupuncture
| Arm | Type | Receives |
|---|---|---|
| Acupuncture | Experimental | Device: AcupunctureGroup 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. |
| Control | No intervention | –No acupuncture treatment provided |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupunctureAcupuncture at points points PC 6 bilaterally, LI 4 bilaterally, and Yin Tang | Device | Acupuncture |
Primary outcome
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
2 secondary outcomes
Postoperative pain
Time frame: 24 hours
Total opioids used
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Cholecystitis, Acute
Not yet recruitingObservational study
SnapChole: An International, Time-Bound Prospective Platform Study of Management Strategies and Outcomes in Acute Calculous Cholecystitis
Cholecystitis, Acute
Not yet recruiting
Percutaneous Drainage Versus EUS-guided Gallbladder Drainage in Poor Surgical Patients With Cholecystitis
Cholecystitis, Acute
RecruitingObservational study
Influence of Gut Microbiome in Gallstone Disease
Gall Stone, Gall Stones, Common Bile Duct
Recruiting
Repeat Biliary Point of Care Ultrasound for Detecting Early Acute Cholecystitis
Cholecystitis, Acute, Biliary Diseases
Not yet recruiting
Implementation of RICA (ERAS) Guidelines in Grade II Acute Cholecystitis Undergoing Early Laparoscopic Cholecystectomy
Cholecystitis, Acute, Cholecystectomy, Laparoscopic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture in people with Cholecystitis, Acute and Cholelithiasis, run by Baylor College of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postoperative nausea and vomiting (time frame: Postoperative: 0-1 hours, 1-6 hours, 6-12 hours, 12-24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2026.