Effect of Preoperative Pregabalin on Propofol Induction Dose

November 6, 2012 updated by: Etienne de Medicis, Université de Sherbrooke
The primary issue is to determine whether preoperatively administered pregabalin decreases the necessary dose of propofol during induction of general anesthesia. The investigators secondary issue is to test if preoperatively administered pregabalin decreases anxiety.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Centre Hospitalier Universitaire de Sherbrooke

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Laparoscopic gynaecologic surgery
  • Age 18-40 years
  • ASA class I or II
  • Body mass index 18-30

Exclusion Criteria:

  • Allergic to pregabalin or gabapentin
  • Chronic renal failure
  • Alcohol or drug abuse
  • Chronic analgesic use other than acetaminophen or NSAID
  • Already taking gabapentin, pregabalin, benzodiazepin or antidepression drug
  • Known neurological deficiency
  • Suspected difficult intubation or ventilation
  • Atypical pseudocholinesterases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Pregabalin
Preoperative administration of pregabalin vs placebo 1 hour before surgery
Other Names:
  • Lyrica
Experimental: Pregabalin
Drug: Pregabalin
Preoperative administration of pregabalin vs placebo 1 hour before surgery
Other Names:
  • Lyrica

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Propofol induction dose
Time Frame: 1 hour
Evaluation of the hpreoperative pregabalin Vs placebo effect on propofol induction dose needed to induce general anesthesia assessed by entropy in gynaecologic patients undertaking minor surgical procedure.
1 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Preoperative anxiety
Time Frame: 1 hour
Evaluation of the effect of pregabalin Vs placebo on preoperative anxiety
1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Université de Sherbrooke

Investigators

  • Principal Investigator: Etienne de Medicis, MD MSc FRCPC, Centre de recherche du Centre hospitalier Universitaire de Sherbrooke

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

July 7, 2010

First Submitted That Met QC Criteria

July 7, 2010

First Posted (Estimate)

July 8, 2010

Study Record Updates

Last Update Posted (Estimate)

November 7, 2012

Last Update Submitted That Met QC Criteria

November 6, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRC09-014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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