Role of Droperidol in Postoperative Vomiting

Aristotle University Of Thessaloniki

Status and phase: Completed; Phase 4

Conditions: Vomiting

Treatments: Drug: Saline solution; Drug: Droperidol

Study type: Interventional

Funder types: Other

Identifiers

NCT00702442

597/4-6-2008

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups, including a placebo group

A

Placebo Comparator group

Description:

Placebo Administrated 30min prior to operation

Treatment:

Drug: Saline solution

B

Experimental group

Description:

0.625 mg Droperidol administrated i.v 30 min prior surgery

Treatment:

Drug: Droperidol