CompletedPhase 4

The Effect of Hyoscine-n-butylbromide on Nausea and Pain in Laparoscopic Cholecystectomy

Turkey (Türkiye)134 participantsStarted 2020-11-15

Plain-language summary

The goal of this randomized double blind study is to compare the effects of hyoscine-n-butylbromide, and ondansetron on postoperative nausea-vomiting, and pain in patients who underwent laparoscopic cholecystectomy.The main questions it aims to answer are: 1\. Is antiemetic properties of hyoscine-n-butylbromide effective after laparoscopic cholecyctectomy? 1\. Does hyoscine-n-butylbromide have valuable effects on postoperative pain after laparoscopic cholecyctectomy? Participants will be the paients undergoing laparoscopic cholecyctectomy. The patients participating in the study were randomized into two groups as Group-HBB, and Group-O. After the gallbladder removed, IV infusion of 1000 mg paracetamol, and 1.5 mg/kg tramadol will administered to the patients. 20 mg hyoscine-n-butylbromide in 100 ml saline will administered to the patients in Group-HBB, and 4 mg ondansetron infusion in 100 ml saline will be administered to the patients in Group-O. Postoperative nausea and vomitting score and pain intensity and rescue drugs will be recorded in postoperative 24 hours.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: ASA score of 1-2 who undergoing laparoscopic cholecystectomy 18-65 years of age Exclusion Criteria: * Patients who are allergic to the drugs used in the study, have an ASA score of 3-4, congestive heart failure or arrhythmia, motion sickness, central nervous system pathology, glaucoma, prostate hypertrophy, and a body mass index above 35, and used antihistamines will not included in the study

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

postoperative nausea and vomiting

Timeframe: 15th, and 30th minutes and at the 3rd, 6th, 12th, and 24th hours.

Postoperative pain

Timeframe: 15th, and 30th minutes and at the 3rd, 6th, 12th, and 24th hours.

Trial details

NCT IDNCT06927817

SponsorSaglik Bilimleri Universitesi

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-11-15

View on ClinicalTrials.gov More Cholecystitis trials