The EC90 of Remifentanil Blunting Hemodynamic Changes to Head Fixation

NCT01489137 | Completed

• 1 other identifier: JHBahk_fixation_remifentanil
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to estimate the EC90 of remifentanil blunting hemodynamic changes to head fixation in the patients undergoing neurosurgery.

Conditions

Brain Tumor; AVM; ICH

Outcome Measures

Primary Outcomes (2)

• mean arterial blood pressure

  mean arterial blood pressure will be recorded at 2 minutes before fixation, 1 minute before fixation, highest value during immediately post-fixation periord, 1 minute after fixation, 2 minutes after fixation, 3 minutes after fixation, 4 minutes after fixation and 5 minutes after fixation.

  peri-fixation periord

• heart rate

  heart rate will be recorded at 2 minutes before fixation, 1 minute before fixation, highest value during immediately post-fixation periord, 1 minute after fixation, 2 minutes after fixation, 3 minutes after fixation, 4 minutes after fixation and 5 minutes after fixation.

  peri-fixation periord

Study Arms (1)

neurosurgery with fixation

EXPERIMENTAL

Drug: remifentanil

Interventions

remifentanil DRUG

According to previous patient's response, the investigators will allocate the effect site concentration of remifentanil of next patient during head fixation. And, For this allocation of dose of remifentanil the investigators use biased coin design up-and-down method. For the first patient, the dose of remifentanil would be fixed at 5.5ng/ml which we predict as EC90. And, step size of dose is 0.5ng/ml.

Also known as: Biased coin design up-and-down method.

neurosurgery with fixation

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients undergoing neurosurgery that require head fixation with mayfield head holder
• patients who agree to our study

You may not qualify if:

• patients who don't agree to our study
• BMI\<16.0 or BMI\>30
• cardiovascular disease, pulmonary disease, renal disease
• alcoholic abuser or drug abuser
• patients who takes any drug having an influence on cardiovascular system or sympathetic nervous system
• any use of local anesthetics or drugs which have an influence on cardiovascular system from beginning of induction to peri-fixation period

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, Seoul, 110-744, South Korea

Location

Related Publications (1)

• Lee JM, Bahk JH, Lim YJ, Lee J, Lim L. The EC90 of remifentanil for blunting cardiovascular responses to head fixation for neurosurgery under total intravenous anesthesia with propofol and remifentanil based on bispectral index monitoring: estimation with the biased coin up-and-down sequential method. BMC Anesthesiol. 2017 Oct 10;17(1):136. doi: 10.1186/s12871-017-0426-z.

  PMID: 29017455 DERIVED

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Remifentanil

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: December 5, 2011
• First Posted: December 9, 2011
• Study Start: November 1, 2011
• Primary Completion: February 1, 2012
• Last Updated: August 17, 2012

Record last verified: 2012-08

Locations

KR (1)