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NCT Number: NCT00702442

Role of Droperidol in Postoperative Vomiting

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

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Key information

Conditions

Vomiting Nausea Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

3rd Department of Surgery, AHEPA University Hospital, Thessaloniki, Macedonia, Greece

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Droperidol

Drug

0.625 mg droperidol administrated i.v prior to laparoscopic cholecystectomy

Saline Solution

Drug

Saline solution administrated i.v 30 min prior surgery

Primary outcomes

  1. Vomiting episodes

    Time frame: 24 hours

Secondary outcomes

  1. Light nausea

    Time frame: 24 hours

  2. Control of nausea

    Time frame: 24 hours

  3. Anti-vomiting treatment

    Time frame: 24 hours

  4. Adverse events

    Time frame: 24 hours

  5. Modification of electrocardiograph

    Time frame: 24 hours

Sponsors and collaborators

Lead sponsor

Aristotle University Of Thessaloniki

Other

Collaborators

  • AHEPA University Hospital

Registry information

Official study title

Role of Droperidol in Postoperative Vomiting: Phase IV Study

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Jun 20, 2008
Registry last updated
Jul 26, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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