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

NCT ID: NCT06927817

Last Updated: 2025-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 134 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-15
• Study Completion Date: 2025-04-08

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.

Detailed Description

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.

Conditions

Cholecystitis; Pain; Nausea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

hyoscine-n-butylbromide

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

Group Type: EXPERIMENTAL

hyoscine-n-butylbromide, ondansetron

Intervention Type: 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

4mg ondansetron infusion in 100ml saline was administered

Group Type: ACTIVE_COMPARATOR

• hyoscine-n-butylbromide • ondansetron

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

• hyoscine-n-butylbromide • ondansetron

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Saglik Bilimleri Universitesi

OTHER

Sponsor Role: lead

Responsible Party

Süheyla Abitağaoğlu

Associate Professor, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Istanbul, Istanbul, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

no sponsorship

Identifier Type: -

Identifier Source: org_study_id