Induction of Anaesthesia Clinical Trial
Official title:
A Phase IV Study to Investigate the Effects of Varied Remifentanil Concentrations on Propofol Requirements for Loss of Consciousness, Response to Painful Stimuli, Bispectral Index and Associated Haemodynamic Changes
A prospective, randomised, phase IV trial including 150 patients.
To evaluate the effects of varied concentrations of remifentanil on the proposal
requirements for the loss of consciousness and response to pain and to evaluate the
haemodynamic changes and processed EEG (BIS) during induction of anaesthesia.
Status | Completed |
Enrollment | 100 |
Est. completion date | August 2015 |
Est. primary completion date | August 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: ASA I or II patients (healthy or with mild systemic illness) undergoing planned surgery requiring general anaesthetic Exclusion Criteria: 1. Subjects with pre-existing neurological or psychiatric illness. 2. Subjects on CNS acting medication or analgesics. |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Hong Kong | Queen Mary Hospital | Pok Fu Lam |
Lead Sponsor | Collaborator |
---|---|
The University of Hong Kong |
Hong Kong,
Absalom AR, Mani V, De Smet T, Struys MM. Pharmacokinetic models for propofol--defining and illuminating the devil in the detail. Br J Anaesth. 2009 Jul;103(1):26-37. doi: 10.1093/bja/aep143. Epub 2009 Jun 10. Review. Erratum in: Br J Anaesth. 2010 Mar;104(3):393. — View Citation
Bouillon TW, Bruhn J, Radulescu L, Andresen C, Shafer TJ, Cohane C, Shafer SL. Pharmacodynamic interaction between propofol and remifentanil regarding hypnosis, tolerance of laryngoscopy, bispectral index, and electroencephalographic approximate entropy. Anesthesiology. 2004 Jun;100(6):1353-72. — View Citation
Guignard B, Menigaux C, Dupont X, Fletcher D, Chauvin M. The effect of remifentanil on the bispectral index change and hemodynamic responses after orotracheal intubation. Anesth Analg. 2000 Jan;90(1):161-7. — View Citation
Iselin-Chaves IA, Flaishon R, Sebel PS, Howell S, Gan TJ, Sigl J, Ginsberg B, Glass PS. The effect of the interaction of propofol and alfentanil on recall, loss of consciousness, and the Bispectral Index. Anesth Analg. 1998 Oct;87(4):949-55. — View Citation
Jee YS, Hong JY. Effects of remifentanil on propofol requirements for loss of consciousness in target-controlled infusion. Minerva Anestesiol. 2008 Jan-Feb;74(1-2):17-22. — View Citation
Liu N, Chazot T, Hamada S, Landais A, Boichut N, Dussaussoy C, Trillat B, Beydon L, Samain E, Sessler DI, Fischler M. Closed-loop coadministration of propofol and remifentanil guided by bispectral index: a randomized multicenter study. Anesth Analg. 2011 Mar;112(3):546-57. doi: 10.1213/ANE.0b013e318205680b. Epub 2011 Jan 13. — View Citation
Lysakowski C, Dumont L, Pellegrini M, Clergue F, Tassonyi E. Effects of fentanyl, alfentanil, remifentanil and sufentanil on loss of consciousness and bispectral index during propofol induction of anaesthesia. Br J Anaesth. 2001 Apr;86(4):523-7. — View Citation
Mertens MJ, Olofsen E, Engbers FH, Burm AG, Bovill JG, Vuyk J. Propofol reduces perioperative remifentanil requirements in a synergistic manner: response surface modeling of perioperative remifentanil-propofol interactions. Anesthesiology. 2003 Aug;99(2):347-59. — View Citation
Minto CF, Schnider TW, Egan TD, Youngs E, Lemmens HJ, Gambus PL, Billard V, Hoke JF, Moore KH, Hermann DJ, Muir KT, Mandema JW, Shafer SL. Influence of age and gender on the pharmacokinetics and pharmacodynamics of remifentanil. I. Model development. Anesthesiology. 1997 Jan;86(1):10-23. — View Citation
Röpcke H, Könen-Bergmann M, Cuhls M, Bouillon T, Hoeft A. Propofol and remifentanil pharmacodynamic interaction during orthopedic surgical procedures as measured by effects on bispectral index. J Clin Anesth. 2001 May;13(3):198-207. — View Citation
Vuyk J, Mertens MJ, Olofsen E, Burm AG, Bovill JG. Propofol anesthesia and rational opioid selection: determination of optimal EC50-EC95 propofol-opioid concentrations that assure adequate anesthesia and a rapid return of consciousness. Anesthesiology. 1997 Dec;87(6):1549-62. — View Citation
* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Effect site concentration of propofol at time of loss of consciousness for each of the two groups | every 1 minute up to 40 minutes | No | |
Primary | Effect site concentration of propofol at loss of response to painful stimuli for each of the three groups | every 1 minute up to 40 minutes | No | |
Secondary | Time to loss of consciousness | every 1 minute up to 40 minutes | No | |
Secondary | EEG Bispectral index BIS | every 1 minute up to 40 minutes | No | |
Secondary | heart rate | every 1 minute up to 40 minutes | No | |
Secondary | blood pressure | every 1 minute up to 40 minutes | No |
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