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NCT03933605 Clinical Trial

Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy

Postoperative Nausea Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03933605
Other study ID # YUMC 2017-04-030
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 10, 2017
Est. completion date February 8, 2019

Study information
Verified date April 2019
Source Yeungnam University College of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 88
Est. completion date February 8, 2019
Est. primary completion date February 1, 2019
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 65 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• midazolam and palonosetron group
intravenous midazolam and palonosetron administraion as prevention of postoperative nausea and vomiting
• palonosetron group
intravenous palonosetron administraion as prevention of postoperative nausea and vomiting

Locations
Country Name City State
Korea, Republic of Eun kyung Choi Daegu Korea (the Republic Of)

Sponsors (1)
Lead Sponsor Collaborator
Yeungnam University College of Medicine

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary incidence of postoperative nausea and vomiting 0=none; 1=occur 24 hours after surgery
Primary severity of postoperative nausea and vomiting 0 = absent; 1 = mild; 2 = moderate; 3 = severe 24 hours after surgery
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