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

NCT06927817 | Completed Phase 4

• 1 other identifier: no sponsorship
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

Brief 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

Cholecystitis; Pain; Nausea

Keywords

Hyoscine N-Butylbromide; Laparoscopic Cholecystectomy; Ondansetron; Pain; Postoperative Nausea and Vomiting

Outcome Measures

Primary Outcomes (2)

• 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)

  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

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

Study Arms (2)

hyoscine-n-butylbromide

EXPERIMENTAL

after removal of gall bladder 20mg hyoscine-n-butylbromide in 100ml saline wİll be administered

Drug: hyoscine-n-butylbromide, ondansetron

ondansetron

ACTIVE COMPARATOR

4mg ondansetron infusion in 100ml saline was administered

Drug: • hyoscine-n-butylbromide • ondansetron

Interventions

• hyoscine-n-butylbromide • ondansetron DRUG

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.

ondansetron

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA score of 1-2 who undergoing laparoscopic cholecystectomy 18-65 years of age

You may not qualify if:

• 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

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

Study Sites (1)

University of Health Sciences Fatih Sultan Mehmet Health Research and Application Center,

Istanbul, Istanbul, 34668, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cholecystitis; Pain; Nausea; Postoperative Nausea and Vomiting

Interventions

Butylscopolammonium Bromide; Ondansetron

Condition Hierarchy (Ancestors)

Gallbladder Diseases; Biliary Tract Diseases; Digestive System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Postoperative Complications; Pathologic Processes; Vomiting

Intervention Hierarchy (Ancestors)

Quaternary Ammonium Compounds; Amines; Organic Chemicals; Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, MD

Study Record Dates

• First Submitted: April 7, 2025
• First Posted: April 15, 2025
• Study Start: November 15, 2020
• Primary Completion: November 15, 2021
• Study Completion: April 8, 2025
• Last Updated: April 17, 2025

Record last verified: 2025-04

Locations

TU (1)