Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy

Not Applicable

Completed

• Conditions: Postoperative Nausea; Postoperative Vomiting
• Interventions: Drug: midazolam and palonosetron group; Drug: palonosetron group

• Registration Number: NCT03933605
• Lead Sponsor: Yeungnam University College of Medicine

Brief Summary

In the present study, midazolam and palonosetron in combination were more effective than palonosetron alone in lowering the incidence and severity of postoperative nausea and vomiting in the initial 2 h after laparoscopic cholecystectomy. Postoperative clinical complications were not different in both groups.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-10
• Primary Completion: 2019-02-01
• Study Completion: 2019-02-08
• Status Verified: 2019-04
• Study First Submitted: 2019-04-28
• Study First Submitted QC: 2019-04-28
• Last Update Submitted: 2019-04-28
• Study First Posted: 2019-05-01
• Last Update Posted: 2019-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 88

Inclusion Criteria

• The patients (aged 20 to 65 years) scheduled for laparoscopic cholecystectomy with American Society of Anesthesiologists (ASA) physical status classification of 1 or 2

Exclusion Criteria

• The patients with a history of allergy to any other drugs used in this study, gastrointestinal disorder, previous PONV, pregnant woman, breastfeeding woman, use of antiemetics within 24 hours or body mass index > 30 kg/m2

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
midazolam and palonosetron	midazolam and palonosetron group	0.05 mg/kg of midazolam i.v. with 0.075 mg of palonosetron i.v. was administered after anesthetic induction
palonosetron	palonosetron group	the same volume (0.05 mg/kg) of normal saline i.v. with 0.075 mg of palonosetron i.v. was administered after anesthetic induction

Primary Outcome Measures

Name	Time	Method
incidence of postoperative nausea and vomiting	24 hours after surgery	0=none; 1=occur
severity of postoperative nausea and vomiting	24 hours after surgery	0 = absent; 1 = mild; 2 = moderate; 3 = severe

Trial Locations

Locations (1)

Eun kyung Choi; 🇰🇷 Daegu, Korea (the Republic Of), Korea, Republic of