Effect of Preoperative Pregabalin on Propofol Induction Dose

Anesthesia, General Clinical Trial

Official title:

Effect of Preoperative Pregabalin on Propofol Induction Dose

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01158859
• Other study ID #: CRC09-014
• Status: Completed
• Phase: Phase 4
• First received: July 7, 2010
• Last updated: November 6, 2012
• Start date: April 2010
• Est. completion date: August 2011

Study information

• Verified date: November 2012
• Source: Université de Sherbrooke
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada : Santé Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anesthesia, General
• Laparoscopic Surgery

Intervention

Drug:
• Pregabalin
Preoperative administration of pregabalin vs placebo 1 hour before surgery

Locations

Country	Name	City	State
Canada	Centre Hospitalier Universitaire de Sherbrooke	Sherbrooke	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Université de Sherbrooke

Country where clinical trial is conducted

Canada, 

References & Publications (16)

Bein B. Entropy. Best Pract Res Clin Anaesthesiol. 2006 Mar;20(1):101-9. Review. — View Citation

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. Epub 2006 Apr 4. — View Citation

Gajraj NM. Pregabalin: its pharmacology and use in pain management. Anesth Analg. 2007 Dec;105(6):1805-15. Review. Erratum in: Anesth Analg.2008 May;106(5):1584. — View Citation

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. Review. — View Citation

Hill CM, Balkenohl M, Thomas DW, Walker R, Mathé H, Murray G. Pregabalin in patients with postoperative dental pain. Eur J Pain. 2001;5(2):119-24. — View Citation

Johansen JW. Update on bispectral index monitoring. Best Pract Res Clin Anaesthesiol. 2006 Mar;20(1):81-99. Review. — View Citation

Jokela R, Ahonen J, Tallgren M, Haanpää 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. Epub 2007 May 15. — View Citation

Jokela R, Ahonen J, Tallgren M, Haanpää 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. — View Citation

Kavoussi R. Pregabalin: From molecule to medicine. Eur Neuropsychopharmacol. 2006 Jul;16 Suppl 2:S128-33. Epub 2006 Jun 9. Review. — View Citation

Kong VK, Irwin MG. Gabapentin: a multimodal perioperative drug? Br J Anaesth. 2007 Dec;99(6):775-86. Review. — View Citation

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. — View Citation

Memis D, Turan A, Karamanlioglu B, Seker S, Türe M. Gabapentin reduces cardiovascular responses to laryngoscopy and tracheal intubation. Eur J Anaesthesiol. 2006 Aug;23(8):686-90. — View Citation

Ménigaux 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):1394-9, table of contents. — View Citation

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. — View Citation

Sills GJ. The mechanisms of action of gabapentin and pregabalin. Curr Opin Pharmacol. 2006 Feb;6(1):108-13. Epub 2005 Dec 22. Review. — View Citation

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. Review. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Preoperative anxiety	Evaluation of the effect of pregabalin Vs placebo on preoperative anxiety	1 hour	No