Anesthesia, GeneralPhase 4NCT01158859
Effect of Preoperative Pregabalin on Propofol Induction Dose
A Phase 4 study testing Pregabalin in people with Anesthesia, General and Laparoscopic Surgery, run by Université de Sherbrooke at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, General, Laparoscopic Surgery
- What is being tested?
- Pregabalin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2010to Aug 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Laparoscopic gynaecologic surgery
- Age 18-40 years
- ASA class I or II
- Body mass index 18-30
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, J1H 5N4
About this study
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.
- Conditions
- Anesthesia, General, Laparoscopic Surgery
- Being tested
- Pregabalin
- Keywords
- Anesthesia, General, Propofol, Pregabalin, Preoperative care, Laparoscopic surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PregabalinDrug
Also called Lyrica
Preoperative administration of pregabalin vs placebo 1 hour before surgery
| Study group | Role | What they receive |
|---|---|---|
| Pregabalin | Experimental | Not described Receives: Drug: Pregabalin |
| Placebo | Placebo comparator | Not described Receives: Drug: Pregabalin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 hour
Secondary outcomes (1)
Preoperative anxiety
Evaluation of the effect of pregabalin Vs placebo on preoperative anxiety
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2010 (estimated)
- Study startApr 2010
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Anesthesia, GeneralStudies of the same condition, open and under way.
- More trials run by Université de SherbrookeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Etienne de Medicis, Université de Sherbrooke
- Investigators
- Etienne de Medicis, MD MSc FRCPC, Principal investigator, Centre de recherche du Centre hospitalier universitaire de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01158859
- Sponsor's protocol ID
- CRC09-014
- Status last verified
- Nov 2012
- First submitted
- 7 Jul 2010
- Last updated
- 7 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 18042886Gilron 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.
PubMed 17873599Sills 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.
PubMed 16376147Kavoussi 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.
PubMed 16765030Hill 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.
PubMed 11465977Mathiesen 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.
PubMed 18653493Jokela 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.
PubMed 18448418Jokela 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.
PubMed 17507163Paech 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.
PubMed 17959981Kong VK, Irwin MG. Gabapentin: a multimodal perioperative drug? Br J Anaesth. 2007 Dec;99(6):775-86. doi: 10.1093/bja/aem316.
PubMed 18006529Memis 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.
PubMed 16805934Fassoulaki 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.
PubMed 16595614Menigaux 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.
PubMed 15845693Johansen 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.
PubMed 16634416Bein B. Entropy. Best Pract Res Clin Anaesthesiol. 2006 Mar;20(1):101-9. doi: 10.1016/j.bpa.2005.07.009.
PubMed 16634417
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Preoperative Pregabalin on Propofol Induction Dose
- ClinicalTrials.gov ID
- NCT01158859
- Acronym / sponsor ID
- CRC09-014
- Conditions
- Anesthesia, General, Laparoscopic Surgery
- Keywords
- Anesthesia, General, Propofol, Pregabalin, Preoperative care, Laparoscopic surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 8 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregabalin | Experimental | Drug: Pregabalin |
| Placebo | Placebo comparator | Drug: Pregabalin |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Laparoscopic gynaecologic surgery
- Age 18-40 years
- ASA class I or II
- Body mass index 18-30
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PregabalinAlso: LyricaPreoperative administration of pregabalin vs placebo 1 hour before surgery | Drug | Placebo, Pregabalin |
Primary outcome
Propofol induction dose
Time frame: 1 hour
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 secondary outcome
Preoperative anxiety
Time frame: 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2012.
- Background: PubMed 18042886Gajraj 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.
- Background: PubMed 17873599Gilron 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.
- Background: PubMed 16376147Sills 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.
- Background: PubMed 16765030Kavoussi 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.
- Background: PubMed 11465977Hill 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.
- Background: PubMed 18653493Mathiesen 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.
- Background: PubMed 18448418Jokela 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.
- Background: PubMed 17507163Jokela 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.
- Background: PubMed 17959981Paech 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.
- Background: PubMed 18006529Kong VK, Irwin MG. Gabapentin: a multimodal perioperative drug? Br J Anaesth. 2007 Dec;99(6):775-86. doi: 10.1093/bja/aem316.
- Background: PubMed 16805934Memis 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.
- Background: PubMed 16595614Fassoulaki 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Etienne de Medicis, MD MSc FRCPC principal investigator
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pregabalin in people with Anesthesia, General and Laparoscopic Surgery, run by Université de Sherbrooke at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Propofol induction dose (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01158859, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2012.