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Effect of Preoperative Pregabalin on Propofol Induction Dose

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Etienne de Medicis, Universitaire de Sherbrooke
ClinicalTrials.gov Identifier:
NCT01158859
First received: July 7, 2010
Last updated: November 6, 2012
Last verified: November 2012
History of Changes
  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
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Preoperative Pregabalin on Propofol Induction Dose

Resource links provided by NLM:

MedlinePlus related topics: Anxiety
U.S. FDA Resources

Further study details as provided by Universitaire de Sherbrooke:

Primary Outcome Measures:
  • Propofol induction dose [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 40 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01158859

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

Publications:

Additional 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
Study First Received: July 7, 2010
Last Updated: November 6, 2012
Health Authority: Canada : Santé Canada

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

Additional relevant MeSH terms:
Propofol
Pregabalin
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
 Central Nervous System Agents
Therapeutic Uses
Hypnotics and Sedatives
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on May 23, 2013