Effect of Preoperative Pregabalin on Propofol Induction Dose

NCT ID: NCT01158859

Last Updated: 2012-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2011-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Anesthesia, General Laparoscopic Surgery

Keywords

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Anesthesia, General Propofol Pregabalin Preoperative care Laparoscopic surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Pregabalin

Group Type EXPERIMENTAL

Pregabalin

Intervention Type DRUG

Preoperative administration of pregabalin vs placebo 1 hour before surgery

Placebo

Group Type PLACEBO_COMPARATOR

Pregabalin

Intervention Type DRUG

Preoperative administration of pregabalin vs placebo 1 hour before surgery

Interventions

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Pregabalin

Preoperative administration of pregabalin vs placebo 1 hour before surgery

Intervention Type DRUG

Other Intervention Names

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Lyrica

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Université de Sherbrooke

OTHER

Sponsor Role lead

Responsible Party

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Etienne de Medicis

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Etienne de Medicis, MD MSc FRCPC

Role: PRINCIPAL_INVESTIGATOR

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Locations

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Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type BACKGROUND
PMID: 18042886 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17873599 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16376147 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16765030 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11465977 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18653493 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18448418 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17507163 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17959981 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 18006529 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16805934 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16595614 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15845693 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16634416 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 16634417 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17513656 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23334782 (View on PubMed)

Other Identifiers

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CRC09-014

Identifier Type: -

Identifier Source: org_study_id