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

NCT06927817 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 134

Last updated 2025-04-17

No results posted yet for this study

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.

Conditions

Interventions

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.

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.

Sponsors & Collaborators

  • Saglik Bilimleri Universitesi

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-11-15
Primary Completion
2021-11-15
Completion
2025-04-08

Countries

  • Turkey (Türkiye)

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06927817 on ClinicalTrials.gov