Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Effect of Preoperative Pregabalin on Propofol Induction Dose

This study has been completed.
Information provided by (Responsible Party):
Etienne de Medicis, Universitaire de Sherbrooke Identifier:
First received: July 7, 2010
Last updated: November 6, 2012
Last verified: November 2012

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:

Further study details as provided by Université 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


Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01158859

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


Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Etienne de Medicis, MD, Universitaire de Sherbrooke 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 Université de Sherbrooke:
Anesthesia, General
Preoperative care
Laparoscopic surgery

Additional relevant MeSH terms:
Calcium Channel Blockers
Cardiovascular Agents
Central Nervous System Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses processed this record on March 03, 2015