Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03933605

Enrollment

Registered

2019-05-01

Start date

2017-07-10

Completion date

2019-02-08

Last updated

2019-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Nausea, Postoperative Vomiting

Keywords

postoperative nausea and vomiting, midazolam, palonosetron

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.

Interventions

DRUGmidazolam and palonosetron group

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

DRUGpalonosetron group

intravenous palonosetron administraion as prevention of postoperative nausea and vomiting

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026