A Phase 4 interventional study of hyoscine-n-butylbromide, ondansetron and • hyoscine-n-butylbromide • ondansetron in Cholecystitis, Pain and Nausea, sponsored by Saglik Bilimleri Universitesi. Completed at 1 site in Turkey. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-17.
Sponsored by Saglik Bilimleri Universitesi · Phase 4, Interventional, and Prevention
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:
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.
After obtaining the informed consent form from the patients, a total of 134 patients undergoingt laparoscopic cholecystectomy surgery will be inclueded in the study. The patients participating in the study will be randomized into two groups as Group-HBB, and Group-O by the closed envelope method. The patients will be blinded to groups they belonged to. Routine peripheral oxygen saturation, noninvasive blood pressure, electrocardiography, and bispectral index (BIS) monitoring will be performed.. BIS-guided 2-2.5mg/kg propofol, and 2mcg/kg fentanyl intravenously, and 0.6mg/kg rocuronium injection will be administered. In order to maintain the BIS value between 40-60, 1-2% sevoflurane inhalation in 40/60% oxygen/air mixture in 2-liter flow, and 0.1-0.5mc/kg/min remifentanil infusion will be applied. 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. After the surgery terminates, 2 mg/kg sugammadex will be used to antagonize the muscle relaxant effect, and patients with adequate respiratory effort, and a BIS value above 85 will be extubated.
Demographic data of the patients such as age, body mass index, gender, comorbidities, ASA score, and smoking status will be recorded. Nausea, vomiting, and pain status will be examined in the recovery unit at postoperative 15th, and 30th minutes and in the ward at the 3rd, 6th, 12th and 24th hours. Follow-ups will be performed by an anesthesiologist who is blind to groups of the patients. A 4-point scale will be used for nausea-vomiting (0: no nausea and vomiting, 1: nausea, no vomiting, 2: nausea, vomiting, 3: vomiting more than twice), and a 10 cm VAS score will be used for assessig the pain level. Patients with a pain level of 4 and above will be administered 20 mg of tenoxicam intravenously as an analgesic. If the nausea score is >0, 10 mg metoclopramide iv will be administered, and if the score was still >0 after 30 minutes, 4 mg dexamethasone iv will be administered.
266 studies on the registry are indexed under Cholecystitis; 46 are open to participants now.
This study's enrollment of 134 is above the median of 86 across 167 interventional studies indexed under Cholecystitis.
Browse Cholecystitis studies →Saglik Bilimleri Universitesi is the lead sponsor of 430 studies on the registry; 136 are open to participants now.
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ASA score of 1-2 who undergoing laparoscopic cholecystectomy 18-65 years of age
Exclusion Criteria:
after removal of gall bladder 20mg hyoscine-n-butylbromide in 100ml saline wİll be administered
Drug: hyoscine-n-butylbromide, ondansetron
4mg ondansetron infusion in 100ml saline was administered
Drug: • hyoscine-n-butylbromide • ondansetron
In patients in Group Hyoscine 20mg hyoscine-n-butylbromide in 100ml saline and in Group Ondansetron 4mg ondansetron infusion in 100ml saline will be administered in Group-O. The patients will be followed-up in terms of nausea, vomiting, and pain at the postoperative 15th, and 30th minutes and at the 3rd, 6th, 12th, and 24th hours.
Also known as: • hyoscine-n-butylbromide • ondansetron
In patients in Group Hyoscine 20mg hyoscine-n-butylbromide in 100ml saline and in Group Ondansetron 4mg ondansetron infusion in 100ml saline will be administered in Group-O. The patients will be followed-up in terms of nausea, vomiting, and pain at the postoperative 15th, and 30th minutes and at the 3rd, 6th, 12th, and 24th hours.
postoperative nausea and vomiting
A 4-point scale will be used for nausea-vomiting (0: no nausea and vomiting, 1: nausea, no vomiting, 2: nausea, vomiting, 3: vomiting more than twice)
Time frame: 15th, and 30th minutes and at the 3rd, 6th, 12th, and 24th hours.
Postoperative pain
10 cm VAS score will be used for assessig the pain level
Time frame: 15th, and 30th minutes and at the 3rd, 6th, 12th, and 24th hours.
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Saglik Bilimleri Universitesi