Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy

Sponsor

Yeungnam University College of Medicine (Other)

Overall Status

Completed

CT.gov ID

NCT03933605

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

4.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Nausea Postoperative Vomiting	Drug: midazolam and palonosetron group Drug: palonosetron group	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

88 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Comparison of Palonosetron With Combined Palonosetron and Midazolam for Preventing Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy

Actual Study Start Date :

Jul 10, 2017

Actual Primary Completion Date :

Feb 1, 2019

Actual Study Completion Date :

Feb 8, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: midazolam and palonosetron 0.05 mg/kg of midazolam i.v. with 0.075 mg of palonosetron i.v. was administered after anesthetic induction	Drug: midazolam and palonosetron group intravenous midazolam and palonosetron administraion as prevention of postoperative nausea and vomiting
Active Comparator: palonosetron 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	Drug: palonosetron group intravenous palonosetron administraion as prevention of postoperative nausea and vomiting

Arm

Intervention/Treatment

Active Comparator: midazolam and palonosetron

0.05 mg/kg of midazolam i.v. with 0.075 mg of palonosetron i.v. was administered after anesthetic induction

Drug: midazolam and palonosetron group

intravenous midazolam and palonosetron administraion as prevention of postoperative nausea and vomiting

Active Comparator: palonosetron

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

Drug: palonosetron group

intravenous palonosetron administraion as prevention of postoperative nausea and vomiting

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 65 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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