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Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy

Primary Purpose

Postoperative Nausea, Postoperative Vomiting

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
midazolam and palonosetron group
palonosetron group
Sponsored by
Yeungnam University College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Nausea focused on measuring postoperative nausea and vomiting, midazolam, palonosetron

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Eun kyung Choi

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

midazolam and palonosetron

palonosetron

Arm Description

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

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

Outcomes

Primary Outcome Measures

incidence of postoperative nausea and vomiting
0=none; 1=occur
severity of postoperative nausea and vomiting
0 = absent; 1 = mild; 2 = moderate; 3 = severe

Secondary Outcome Measures

Full Information

First Posted
April 28, 2019
Last Updated
April 28, 2019
Sponsor
Yeungnam University College of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT03933605
Brief Title
Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy
Official Title
Comparison of Palonosetron With Combined Palonosetron and Midazolam for Preventing Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
July 10, 2017 (Actual)
Primary Completion Date
February 1, 2019 (Actual)
Study Completion Date
February 8, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yeungnam University College of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Nausea, Postoperative Vomiting
Keywords
postoperative nausea and vomiting, midazolam, palonosetron

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
88 (Actual)

8. Arms, Groups, and Interventions

Arm Title
midazolam and palonosetron
Arm Type
Active Comparator
Arm Description
0.05 mg/kg of midazolam i.v. with 0.075 mg of palonosetron i.v. was administered after anesthetic induction
Arm Title
palonosetron
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
midazolam and palonosetron group
Intervention Description
intravenous midazolam and palonosetron administraion as prevention of postoperative nausea and vomiting
Intervention Type
Drug
Intervention Name(s)
palonosetron group
Intervention Description
intravenous palonosetron administraion as prevention of postoperative nausea and vomiting
Primary Outcome Measure Information:
Title
incidence of postoperative nausea and vomiting
Description
0=none; 1=occur
Time Frame
24 hours after surgery
Title
severity of postoperative nausea and vomiting
Description
0 = absent; 1 = mild; 2 = moderate; 3 = severe
Time Frame
24 hours after surgery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Eun kyung Choi
City
Daegu
State/Province
Korea (the Republic Of)
ZIP/Postal Code
41944
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy

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