Role of Droperidol in Postoperative Vomiting

Role of Droperidol in Postoperative Vomiting: Phase IV Study

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00702442

Enrollment

100

Registered

2008-06-20

Start date

2008-06-30

Completion date

2011-07-31

Last updated

2011-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vomiting

Keywords

Nausea, Vomiting, Vomiting episodes

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.

Interventions

DRUGDroperidol

0.625 mg droperidol administrated i.v prior to laparoscopic cholecystectomy

DRUGSaline solution

Saline solution administrated i.v 30 min prior surgery

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Vomiting episodes	24 hours

Secondary

Measure	Time frame
Light nausea	24 hours
Control of nausea	24 hours
Anti-vomiting treatment	24 hours
Adverse events	24 hours
Modification of electrocardiograph	24 hours

Countries

Greece

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026