Role of Droperidol in Postoperative Vomiting
1 other identifier
interventional
100
1 country
2
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jun 2008
Typical duration for phase_4
2 active sites
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
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 19, 2008
CompletedFirst Posted
Study publicly available on registry
June 20, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2011
CompletedJuly 26, 2011
September 1, 2009
3.1 years
June 19, 2008
July 25, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Vomiting episodes
24 hours
Secondary Outcomes (5)
Light nausea
24 hours
Control of nausea
24 hours
Anti-vomiting treatment
24 hours
Adverse events
24 hours
Modification of electrocardiograph
24 hours
Study Arms (2)
A
PLACEBO COMPARATORPlacebo Administrated 30min prior to operation
B
EXPERIMENTAL0.625 mg Droperidol administrated i.v 30 min prior surgery
Interventions
Eligibility Criteria
You may qualify if:
- Patient more than 18 years old
- Patients scheduled for laparoscopic cholecystectomy
- Informed consent obtained from the patient
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Aristotle University Of Thessalonikilead
- AHEPA University Hospitalcollaborator
Study Sites (2)
3rd Department of Surgery, AHEPA University Hospital
Thessaloniki, Macedonia, 55236, Greece
3rd Department of Surgery, AHEPA University Hospital
Thessaloniki, 55236, Greece
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Isaak Kesisoglou
Associate Professor in Surgery
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 19, 2008
First Posted
June 20, 2008
Study Start
June 1, 2008
Primary Completion
July 1, 2011
Study Completion
July 1, 2011
Last Updated
July 26, 2011
Record last verified: 2009-09