A Phase IV Study Investigating the Effects of Remifentanil Concentrations on Propofol Requirements for Loss of Consciousness, Response to Painful Stimuli, Bispectral Index and Associated Haemodynamic Changes

NCT02287181 | Completed Phase 4

• 1 other identifier: uhongkong
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Induction of Anaesthesia

Outcome Measures

Primary Outcomes (2)

• Effect site concentration of propofol at time of loss of consciousness for each of the two groups

  every 1 minute up to 40 minutes

• 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

Secondary Outcomes (4)

• Time to loss of consciousness

  every 1 minute up to 40 minutes

• EEG Bispectral index BIS

  every 1 minute up to 40 minutes

• heart rate

  every 1 minute up to 40 minutes

• blood pressure

  every 1 minute up to 40 minutes

Study Arms (2)

remifentanil effect site concentration 0ng/ml

ACTIVE COMPARATOR

remifentanil run as an infusion using the minto TCI model, at an effect site concentration of 0 nano grams per millilitre, commenced from start of proposal infusion to point at which patient is anaesthetised and not responding to painful stimuli.

Drug: Remifentanil; Drug: Propofol; Other: Bispectral index

remifentanil effect site concentration 3ng/ml

ACTIVE COMPARATOR

remifentanil run as an infusion using the minto TCI model, at an effect site concentration of 3 nano grams per millilitre, commenced from start of proposal infusion to point at which patient is anaesthetised and not responding to painful stimuli.

Drug: Remifentanil; Drug: Propofol; Other: Bispectral index

Interventions

Remifentanil DRUG

short acting opiate

remifentanil effect site concentration 0ng/ml; remifentanil effect site concentration 3ng/ml

Propofol DRUG

hypnotic drug

remifentanil effect site concentration 0ng/ml; remifentanil effect site concentration 3ng/ml

Bispectral index OTHER

electroencephalograph

remifentanil effect site concentration 0ng/ml; remifentanil effect site concentration 3ng/ml

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA I or II patients (healthy or with mild systemic illness) undergoing planned surgery requiring general anaesthetic

You may not qualify if:

• Subjects with pre-existing neurological or psychiatric illness.
• Subjects on CNS acting medication or analgesics.

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Queen Mary Hospital

Pok Fu Lam, Hong Kong

Location

Related Publications (11)

• 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. doi: 10.1097/00000542-199712000-00033. No abstract available.

  PMID: 9416739 BACKGROUND

• 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.

  PMID: 19520702 BACKGROUND

• 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. doi: 10.1097/00000542-199701000-00004.

  PMID: 9009935 BACKGROUND

• 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. doi: 10.1097/00000539-199810000-00038.

  PMID: 9768800 BACKGROUND

• 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. doi: 10.1097/00000542-200308000-00016.

  PMID: 12883407 BACKGROUND

• 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.

  PMID: 18216764 BACKGROUND

• 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. doi: 10.1097/00000542-200406000-00006.

  PMID: 15166553 BACKGROUND

• Ropcke H, Konen-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. doi: 10.1016/s0952-8180(01)00255-0.

  PMID: 11377158 BACKGROUND

• 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. doi: 10.1097/00000539-200001000-00034.

  PMID: 10624998 BACKGROUND

• 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. doi: 10.1093/bja/86.4.523.

  PMID: 11573626 BACKGROUND

• 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.

  PMID: 21233500 BACKGROUND

MeSH Terms

Interventions

Remifentanil; Propofol; Consciousness Monitors

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Surgical Equipment; Equipment and Supplies

Study Officials

• Michael Irwin, MbChB

  Hong Kong University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate

Study Record Dates

• First Submitted: October 24, 2014
• First Posted: November 10, 2014
• Study Start: February 1, 2015
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: March 11, 2016

Record last verified: 2015-03

Locations

HK (1)