Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy
Comparison of Palonosetron With Combined Palonosetron and Midazolam for Preventing Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy
1 other identifier
interventional
88
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 10, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 8, 2019
CompletedFirst Submitted
Initial submission to the registry
April 28, 2019
CompletedFirst Posted
Study publicly available on registry
May 1, 2019
CompletedMay 1, 2019
April 1, 2019
1.6 years
April 28, 2019
April 28, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
incidence of postoperative nausea and vomiting
0=none; 1=occur
24 hours after surgery
severity of postoperative nausea and vomiting
0 = absent; 1 = mild; 2 = moderate; 3 = severe
24 hours after surgery
Study Arms (2)
midazolam and palonosetron
ACTIVE COMPARATOR0.05 mg/kg of midazolam i.v. with 0.075 mg of palonosetron i.v. was administered after anesthetic induction
palonosetron
ACTIVE COMPARATORthe same volume (0.05 mg/kg) of normal saline i.v. with 0.075 mg of palonosetron i.v. was administered after anesthetic induction
Interventions
intravenous midazolam and palonosetron administraion as prevention of postoperative nausea and vomiting
intravenous palonosetron administraion as prevention of postoperative nausea and vomiting
Eligibility Criteria
You may qualify if:
- The patients (aged 20 to 65 years) scheduled for laparoscopic cholecystectomy with American Society of Anesthesiologists (ASA) physical status classification of 1 or 2
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Eun kyung Choi
Daegu, Korea (the Republic Of), 41944, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
April 28, 2019
First Posted
May 1, 2019
Study Start
July 10, 2017
Primary Completion
February 1, 2019
Study Completion
February 8, 2019
Last Updated
May 1, 2019
Record last verified: 2019-04
Data Sharing
- IPD Sharing
- Will share