The EC50 of Remifentanil Blunting Hemodynamic Response to Double Lumen Tube Intubation

NCT01542099 | Completed DMC

• 1 other identifier: JHBahk_DLT_remi
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the effect site concentration of remifentanil blunting hemodynamic changes to tracheal intubation of single or double lumen tubes.

Conditions

Hemodynamic Responses During Tracheal Intubation

Outcome Measures

Primary Outcomes (1)

• Changes from baseline in heart rate and mean arterial pressure after intubation

  Heart rate and mean arterial pressure will be recorded at 2 minutes before intubation, 1 minute before intubation, during intubation, 1 minute after intubation. The mean value of heart rate and mean arterial pressure before intubation will be regarded as the baseline values. If maximum heart rate or mean arterial pressure after intubation increased by \>15% from baseline value, the response will be regarded as "fail" and increased concentration of remifentanil will be applied to next patient by up and down sequential method.

  intubation period

Study Arms (2)

Single lumen tube

ACTIVE COMPARATOR

Single lumen tube intubation during remifentanil infusion

Drug: Remifentanil

Double lumen tube

ACTIVE COMPARATOR

Double lumen tube intubation during remifentanil infusion

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 double lumen tube intubation. For this allocation of dose of remifentanil the investigators use up-and-down method. For the first patient, the dose of remifentanil would be fixed at 6.0 ng/ml which we predict as EC50. And, step size of dose is 0.5ng/ml.

Double lumen tube

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 thoracic surgery that require one lung ventilation

You may not qualify if:

• patient who does not agree with this study
• BMI \< 16.0 or BMI \> 30
• cardiovascular disease, pulmonary disease, renal disease
• alcoholic abuser or drug abuser
• patient who takes any drug to influence cardiovascular system or sympathetic nervous system
• any use of local anesthetics or drugs to influence cardiovascular system during tracheal intubation

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, Seoul, 110-744, South Korea

Location

Related Publications (1)

• Kim TK, Hong DM, Lee SH, Paik H, Min SH, Seo JH, Jung CW, Bahk JH. Effect-site concentration of remifentanil required to blunt haemodynamic responses during tracheal intubation: A randomized comparison between single- and double-lumen tubes. J Int Med Res. 2018 Jan;46(1):430-439. doi: 10.1177/0300060517721072. Epub 2017 Jul 21.

  PMID: 28730932 DERIVED

MeSH Terms

Interventions

Remifentanil

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: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: February 9, 2012
• First Posted: March 2, 2012
• Study Start: November 1, 2011
• Primary Completion: April 1, 2012
• Study Completion: December 1, 2012
• Last Updated: April 20, 2016

Record last verified: 2016-04

Locations

KR (1)