NCT01158859

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Apr 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 7, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 8, 2010

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

November 7, 2012

Status Verified

November 1, 2012

Enrollment Period

1.3 years

First QC Date

July 7, 2010

Last Update Submit

November 6, 2012

Conditions

Anesthesia, GeneralLaparoscopic Surgery

Keywords

Anesthesia, GeneralPropofolPregabalinPreoperative careLaparoscopic surgery

Outcome Measures

Primary Outcomes (1)

  • Propofol induction dose

    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 Outcomes (1)

  • Preoperative anxiety

    1 hour

Study Arms (2)

Pregabalin

EXPERIMENTAL
Drug: Pregabalin

Placebo

PLACEBO COMPARATOR
Drug: Pregabalin

Interventions

PregabalinDRUG

Preoperative administration of pregabalin vs placebo 1 hour before surgery

Also known as: Lyrica
PlaceboPregabalin

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Related Publications (17)

  • Gajraj NM. Pregabalin: its pharmacology and use in pain management. Anesth Analg. 2007 Dec;105(6):1805-15. doi: 10.1213/01.ane.0000287643.13410.5e.

    PMID: 18042886BACKGROUND

  • Gilron I. Gabapentin and pregabalin for chronic neuropathic and early postsurgical pain: current evidence and future directions. Curr Opin Anaesthesiol. 2007 Oct;20(5):456-72. doi: 10.1097/ACO.0b013e3282effaa7.

    PMID: 17873599BACKGROUND

  • Sills GJ. The mechanisms of action of gabapentin and pregabalin. Curr Opin Pharmacol. 2006 Feb;6(1):108-13. doi: 10.1016/j.coph.2005.11.003. Epub 2005 Dec 22.

    PMID: 16376147BACKGROUND

  • Kavoussi R. Pregabalin: From molecule to medicine. Eur Neuropsychopharmacol. 2006 Jul;16 Suppl 2:S128-33. doi: 10.1016/j.euroneuro.2006.04.005. Epub 2006 Jun 9.

    PMID: 16765030BACKGROUND

  • Hill CM, Balkenohl M, Thomas DW, Walker R, Mathe H, Murray G. Pregabalin in patients with postoperative dental pain. Eur J Pain. 2001;5(2):119-24. doi: 10.1053/eujp.2001.0235.

    PMID: 11465977BACKGROUND

  • Mathiesen O, Jacobsen LS, Holm HE, Randall S, Adamiec-Malmstroem L, Graungaard BK, Holst PE, Hilsted KL, Dahl JB. Pregabalin and dexamethasone for postoperative pain control: a randomized controlled study in hip arthroplasty. Br J Anaesth. 2008 Oct;101(4):535-41. doi: 10.1093/bja/aen215. Epub 2008 Jul 23.

    PMID: 18653493BACKGROUND

  • Jokela R, Ahonen J, Tallgren M, Haanpaa M, Korttila K. Premedication with pregabalin 75 or 150 mg with ibuprofen to control pain after day-case gynaecological laparoscopic surgery. Br J Anaesth. 2008 Jun;100(6):834-40. doi: 10.1093/bja/aen098. Epub 2008 Apr 29.

    PMID: 18448418BACKGROUND

  • Jokela R, Ahonen J, Tallgren M, Haanpaa M, Korttila K. A randomized controlled trial of perioperative administration of pregabalin for pain after laparoscopic hysterectomy. Pain. 2008 Jan;134(1-2):106-12. doi: 10.1016/j.pain.2007.04.002. Epub 2007 May 15.

    PMID: 17507163BACKGROUND

  • Paech MJ, Goy R, Chua S, Scott K, Christmas T, Doherty DA. A randomized, placebo-controlled trial of preoperative oral pregabalin for postoperative pain relief after minor gynecological surgery. Anesth Analg. 2007 Nov;105(5):1449-53, table of contents. doi: 10.1213/01.ane.0000286227.13306.d7.

    PMID: 17959981BACKGROUND

  • Kong VK, Irwin MG. Gabapentin: a multimodal perioperative drug? Br J Anaesth. 2007 Dec;99(6):775-86. doi: 10.1093/bja/aem316.

    PMID: 18006529BACKGROUND

  • Memis D, Turan A, Karamanlioglu B, Seker S, Ture M. Gabapentin reduces cardiovascular responses to laryngoscopy and tracheal intubation. Eur J Anaesthesiol. 2006 Aug;23(8):686-90. doi: 10.1017/S0265021506000500.

    PMID: 16805934BACKGROUND

  • Fassoulaki A, Melemeni A, Paraskeva A, Petropoulos G. Gabapentin attenuates the pressor response to direct laryngoscopy and tracheal intubation. Br J Anaesth. 2006 Jun;96(6):769-73. doi: 10.1093/bja/ael076. Epub 2006 Apr 4.

    PMID: 16595614BACKGROUND

  • Menigaux C, Adam F, Guignard B, Sessler DI, Chauvin M. Preoperative gabapentin decreases anxiety and improves early functional recovery from knee surgery. Anesth Analg. 2005 May;100(5):1394-1399. doi: 10.1213/01.ANE.0000152010.74739.B8.

    PMID: 15845693BACKGROUND

  • Johansen JW. Update on bispectral index monitoring. Best Pract Res Clin Anaesthesiol. 2006 Mar;20(1):81-99. doi: 10.1016/j.bpa.2005.08.004.

    PMID: 16634416BACKGROUND

  • Bein B. Entropy. Best Pract Res Clin Anaesthesiol. 2006 Mar;20(1):101-9. doi: 10.1016/j.bpa.2005.07.009.

    PMID: 16634417BACKGROUND

  • Tiippana EM, Hamunen K, Kontinen VK, Kalso E. Do surgical patients benefit from perioperative gabapentin/pregabalin? A systematic review of efficacy and safety. Anesth Analg. 2007 Jun;104(6):1545-56, table of contents. doi: 10.1213/01.ane.0000261517.27532.80.

    PMID: 17513656BACKGROUND

  • Moreau-Bussiere F, Gaulin J, Gagnon V, Sansoucy Y, de Medicis E. Preoperative pregabalin does not reduce propofol ED(50): a randomized controlled trial. Can J Anaesth. 2013 Apr;60(4):364-9. doi: 10.1007/s12630-013-9885-y. Epub 2013 Jan 19.

    PMID: 23334782DERIVED

MeSH Terms

Interventions

Pregabalin

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Etienne de Medicis, MD MSc FRCPC

    Centre de recherche du Centre hospitalier universitaire de Sherbrooke

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

July 7, 2010

First Posted

July 8, 2010

Study Start

April 1, 2010

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

November 7, 2012

Record last verified: 2012-11

Locations

CA(1)