New wash may ease pain and nausea after gallbladder surgery
NCT ID NCT06632184
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether adding the anti-nausea drug ondansetron to a standard saline wash during gallbladder surgery can better control pain and nausea afterward. Forty adults having their gallbladder removed will be randomly assigned to receive either a plain saline wash or one with ondansetron. The goal is to see if the drug helps reduce discomfort and improve recovery in the first 24 hours.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2025
- Expected to finish
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Mar 2026
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a government body.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 60 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Eligible participants will be adult patients scheduled for elective laparoscopic cholecystectomy at the study site. To ensure a homogeneous sample appropriate for this pilot trial, strict inclusion and exclusion criteria have been defined. Inclusion criteria Patients meeting all the following criteria will be considered for enrollment: 1. Aged between 18 and 60 years. 2. American Society of Anesthesiologist (ASA) physical status classification I or II. 3. Scheduled for elective laparoscopic cholecystectomy due to symptomatic cholelithiasis, resolved choledocholithiasis post-endoscopic retrograde cholangiopancreatography (ERCP), or gallbladder polyp. 4. Placement of a ¾-inch Penrose drain in the subhepatic cavity as part of the standardized surgical technique, to allow evacuation of residual CO2, residual lavage fluid, and close monitoring for possible postoperative bleeding or bile leakage. 5. Intraoperative surgical difficulty assessed as Grade I, II or III according to the Nassar scale 6. Ability to provide written, informed consent Exclusion Criteria Patients presenting with any of the following will be excluded: 1. Confirmed pregnancy or lactation 2. Intraoperative findings of Nassar Grade IV, suspected gallbladder cancer, scleroatrophic gallbladder, or cirrhosis 5\. Use of NSAIDs within 24 hours prior to surgery, or chronic use of NSAIDs, opioids, immunosuppressants, chemotherapy, or anticoagulants. 6\. Known allergies to ondansetron, acetaminophen, diclofenac sodium, buprenorphine or tramadol 7\. Significant cardiac disease (e.g., heart failure, arrhythmias, pacemaker dependency) 8\. Obesity Grade IV (Body Mass Index ≥ 50 kg/m2) 9\. History of recurrent vertigo or motion sickness Elimination Criteria Patients who meet inclusion criteria but experience the following intraoperative events will be eliminated from the final per-protocol analysis: significant bleeding or bile duct injury requiring re-intervention, conversion to open surgery, or a total operative time exceeding 80 minutes.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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General Hospital No. 89 of the Mexican Social Security Institute (IMSS)
Guadalajara, Jalisco, 44190, Mexico
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Two-Drug combo tested to stop Post-Surgery nausea
- Can a cold pack on the neck calm Post-Surgery nausea?
- Nerve block before or after surgery: which timing better blocks pain?
- Can a simple injection replace opioids after gallbladder surgery?
- Could a stick of gum ease post-surgery nausea and get bowels moving again?