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Effect of Preoperative Pregabalin on Propofol Induction Dose

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01158859
First Posted: July 8, 2010
Last Update Posted: November 7, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Etienne de Medicis, Universitaire de Sherbrooke
  Purpose
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.

Condition Intervention Phase
Anesthesia, General Laparoscopic Surgery Drug: Pregabalin Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Preoperative Pregabalin on Propofol Induction Dose

Resource links provided by NLM:


Further study details as provided by Etienne de Medicis, Universitaire de Sherbrooke:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • Preoperative anxiety [ Time Frame: 1 hour ]
    Evaluation of the effect of pregabalin Vs placebo on preoperative anxiety


Estimated Enrollment: 50
Study Start Date: April 2010
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pregabalin Drug: Pregabalin
Preoperative administration of pregabalin vs placebo 1 hour before surgery
Other Name: Lyrica
Placebo Comparator: Placebo Drug: Pregabalin
Preoperative administration of pregabalin vs placebo 1 hour before surgery
Other Name: Lyrica

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01158859


Locations
Canada, Quebec
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, Canada, J1H 5N4
Sponsors and Collaborators
Université de Sherbrooke
Investigators
Principal Investigator: Etienne de Medicis, MD MSc FRCPC Centre de recherche du Centre hospitalier universitaire de Sherbrooke
  More Information

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Etienne de Medicis, MD, Universitaire de Sherbrooke
ClinicalTrials.gov Identifier: NCT01158859     History of Changes
Other Study ID Numbers: CRC09-014
First Submitted: July 7, 2010
First Posted: July 8, 2010
Last Update Posted: November 7, 2012
Last Verified: November 2012

Keywords provided by Etienne de Medicis, Universitaire de Sherbrooke:
Anesthesia, General
Propofol
Pregabalin
Preoperative care
Laparoscopic surgery

Additional relevant MeSH terms:
Propofol
Pregabalin
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs