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Role of Droperidol in Postoperative Vomiting

Primary Purpose

Vomiting

Status
Completed
Phase
Phase 4
Locations
Greece
Study Type
Interventional
Intervention
Droperidol
Saline solution
Sponsored by
Aristotle University Of Thessaloniki
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Vomiting focused on measuring Nausea, Vomiting, Vomiting episodes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient more than 18 years old
  • Patients scheduled for laparoscopic cholecystectomy
  • Informed consent obtained from the patient

Exclusion Criteria:

  • Age < 18 years old
  • Contraindication to laparoscopic surgery
  • Present a severe depressive syndrome
  • Pregnancy women
  • Trouble of cardiac rate
  • Alcoholism
  • Contra-indication for Droperidol prescription

Sites / Locations

  • 3rd Department of Surgery, AHEPA University Hospital
  • 3rd Department of Surgery, AHEPA University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

A

B

Arm Description

Placebo Administrated 30min prior to operation

0.625 mg Droperidol administrated i.v 30 min prior surgery

Outcomes

Primary Outcome Measures

Vomiting episodes

Secondary Outcome Measures

Light nausea
Control of nausea
Anti-vomiting treatment
Adverse events
Modification of electrocardiograph

Full Information

First Posted
June 19, 2008
Last Updated
July 25, 2011
Sponsor
Aristotle University Of Thessaloniki
Collaborators
AHEPA University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00702442
Brief Title
Role of Droperidol in Postoperative Vomiting
Official Title
Role of Droperidol in Postoperative Vomiting: Phase IV Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Aristotle University Of Thessaloniki
Collaborators
AHEPA University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Protocol title: Role of low dose droperidol in postoperative vomiting Purpose: Evaluate the efficacy of droperidol to postoperative nausea and vomiting when administrated at the introduction to anesthesia, prior to surgery Design: Prospective, randomized, placebo-controlled study Patient Population: Male or female subjects 18 years of age or older who are scheduled for laparoscopic cholecystectomy No. of Subjects: 100 patients divided into two groups, estimated up to 6 months to enroll Duration of Treatment: Prior operation Duration of Follow-up: Follow-up will be performed for 24 hours postoperatively Endpoints: To evaluate the effectiveness of low dose droperidol when administered Prior surgery
Detailed Description
In this prospective, randomized, placebo-controlled study, the researchers determined whether 0.625 mg (1/2 amp) IV droperidol given at the initiation of general anesthesia reduces the incidence of immediate and delayed post operative nausea and vomiting (PONV) in laparoscopic cholecystectomy population. One hundred patients receiving general anesthesia for laparoscopic cholecystectomy received droperidol 0.625 mg (1/2 amp) mg or placebo prior operation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vomiting
Keywords
Nausea, Vomiting, Vomiting episodes

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Placebo Comparator
Arm Description
Placebo Administrated 30min prior to operation
Arm Title
B
Arm Type
Experimental
Arm Description
0.625 mg Droperidol administrated i.v 30 min prior surgery
Intervention Type
Drug
Intervention Name(s)
Droperidol
Intervention Description
0.625 mg droperidol administrated i.v prior to laparoscopic cholecystectomy
Intervention Type
Drug
Intervention Name(s)
Saline solution
Intervention Description
Saline solution administrated i.v 30 min prior surgery
Primary Outcome Measure Information:
Title
Vomiting episodes
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Light nausea
Time Frame
24 hours
Title
Control of nausea
Time Frame
24 hours
Title
Anti-vomiting treatment
Time Frame
24 hours
Title
Adverse events
Time Frame
24 hours
Title
Modification of electrocardiograph
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient more than 18 years old Patients scheduled for laparoscopic cholecystectomy Informed consent obtained from the patient Exclusion Criteria: Age < 18 years old Contraindication to laparoscopic surgery Present a severe depressive syndrome Pregnancy women Trouble of cardiac rate Alcoholism Contra-indication for Droperidol prescription
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Isaak Kesisoglou
Organizational Affiliation
Associate Professor in Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
3rd Department of Surgery, AHEPA University Hospital
City
Thessaloniki
State/Province
Macedonia
ZIP/Postal Code
55236
Country
Greece
Facility Name
3rd Department of Surgery, AHEPA University Hospital
City
Thessaloniki
ZIP/Postal Code
55236
Country
Greece

12. IPD Sharing Statement

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Role of Droperidol in Postoperative Vomiting

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