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
About this trial
This is an interventional prevention trial for Vomiting focused on measuring Nausea, Vomiting, Vomiting episodes
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
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
NCT ID
NCT00702442
First Posted
June 19, 2008
Last Updated
July 25, 2011
Sponsor
Aristotle University Of Thessaloniki
Collaborators
AHEPA University Hospital
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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