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临床试验/NCT06927817
NCT06927817已完成4 期

The Effect of Hyoscine-N-Butylbromide on Nausea and Pain in Laparoscopic Cholecystectomy: A Prospective Randomized Study

Saglik Bilimleri Universitesi1 个研究点 分布在 1 个国家目标入组 134 人开始时间: 2020年11月15日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
已完成
入组人数
134
试验地点
1
主要终点
postoperative nausea and vomiting

研究概览

简要总结

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?

  2. 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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

研究组 & 干预措施

hyoscine-n-butylbromide

Experimental

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

干预措施: hyoscine-n-butylbromide, ondansetron (Drug)

ondansetron

Active Comparator

4mg ondansetron infusion in 100ml saline was administered

干预措施: • hyoscine-n-butylbromide • ondansetron (Drug)

结局指标

主要结局

postoperative nausea and vomiting

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

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)

Postoperative pain

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

10 cm VAS score will be used for assessig the pain level

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Süheyla Abitağaoğlu

Associate Professor, MD

Saglik Bilimleri Universitesi

研究点 (1)

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