Role of Droperidol in Postoperative Vomiting
Information source: Aristotle University Of Thessaloniki
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Vomiting
Intervention: Droperidol (Drug); Saline solution (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Aristotle University Of Thessaloniki Overall contact:
Isaak I Kesisoglou, M.D, PhD, Phone: +2310994602, Email: ikesis@hotmail.com
Summary
Protocol Synopsis
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
Clinical Details
Official title: Role of Droperidol in Postoperative Vomiting: Phase IV Study
Study design: Prevention, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: Vomiting episodes
Secondary outcome: Light nausea
Control of nausea
Anti-vomiting treatment
Adverse events
Modification of electrocardiograph
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
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Isaak I Kesisoglou, M.D, PhD, Phone: +2310994602, Email: ikesis@hotmail.com
3rd Department of Surgery, AHEPA University Hospital, Thessaloniki, Macedonia 55236, Greece; Recruiting
Isaak I Kesisoglou, M.D, PhD, Phone: +2310994602, Email: ikesis@hotmail.com
Isaak I Kesisoglou, M.D, PhD, Principal Investigator
Vasilios Grosomanidis, M.D, PhD, Principal Investigator
Ellada Kiourtsieva, M.D, Sub-Investigator
Theodossis S Papavramidis, M.D, Sub-Investigator
Additional Information
Starting date: June 2008
Ending date: February 2009
Last updated: January 27, 2009
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