Effect-site Concentration of Remifentanil for Smooth Induction With Desflurane

Sponsor

Ajou University School of Medicine (Other)

Overall Status

Completed

CT.gov ID

NCT02379715

Collaborator

(none)

Enrollment

Arm

Duration (Months)

Study Details

Study Description

Brief Summary

Desflurane is a halogenated ether with low solubility, giving rapid induction and emergence from anesthesia This character is suitable for Volatile Induction and Maintenance Anesthesia (VIMA). But desflurane can cause airway irritation when it used as a sole induction agent to adult or children, so there were many studies about reducing the airway reflex combined with desflurane.

Remifentanil is a short acting opioid and is quickly hydrolyzed by nonspecific esterase in the plasma and multiorgan. Several studies suggest the optimal dose of remifentanil for reducing airway reflex or cardiovascular response for intubation combined with desflurane. But these studies were under 1 Minimal Alveolar Concentration (MAC) of desflurane and this point could be a limitation because desflurane concentration over 1 MAC increase airway irritation significantly. This study this study was designed to determine a median effective effect-site concentration (EC50) of remifentanil to prevent airway irritation during desflurane anesthesia over 1 MAC.

Condition or Disease	Intervention/Treatment	Phase
Anesthesia	Drug: Remifentanil Drug: Desflurane	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

26 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Other

Official Title:

Effect-site Concentration of Remifentanil for Smooth Induction With Desflurane

Study Start Date :

Dec 1, 2014

Actual Primary Completion Date :

May 1, 2015

Actual Study Completion Date :

May 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Remifentanil When the particapants arrived into the operating room, the investigators applied standard monitoring and after preoxygenation, 2 mg remifentanil was diluted into 50 ml of normal saline (40 μg/ml solution) and was infused by Target concentration infusion (TCI) via syringe pump (Pilot Anesthesia 2. Fresenius vial, France) using the pharmacokinetic model. Investigator started to infuse remifentanil at 4 ng/ml and after the Ce of remifentanil reached the target concentration level, opened the dial of desflurane vaporizer at 4 vol%. After 30 seconds, increase the concentration of desflurane 8% and 12% at last. If there is no spontaneous respiration or loss of consciousness, the muscle relaxant esmerone 0.6mg/kg is injected and after 90 seconds the tracheal intubation is performed.	Drug: Remifentanil Other Names: Ultiva Drug: Desflurane

Arm

Intervention/Treatment

Experimental: Remifentanil

When the particapants arrived into the operating room, the investigators applied standard monitoring and after preoxygenation, 2 mg remifentanil was diluted into 50 ml of normal saline (40 μg/ml solution) and was infused by Target concentration infusion (TCI) via syringe pump (Pilot Anesthesia 2. Fresenius vial, France) using the pharmacokinetic model. Investigator started to infuse remifentanil at 4 ng/ml and after the Ce of remifentanil reached the target concentration level, opened the dial of desflurane vaporizer at 4 vol%. After 30 seconds, increase the concentration of desflurane 8% and 12% at last. If there is no spontaneous respiration or loss of consciousness, the muscle relaxant esmerone 0.6mg/kg is injected and after 90 seconds the tracheal intubation is performed.

Drug: Remifentanil

Other Names:

Ultiva

Drug: Desflurane

Outcome Measures

Primary Outcome Measures

Fail or success for induction with desflurane [After loss of consciousness, 5 seconds]
Failure for induction with desflurane is defined if there is a cough, laryngospasm, hypoxia or any refusal movement of patient.

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

patients for surgery requiring general anesthesia
American Society of Anesthesiologists(ASA) classification I, II

Exclusion Criteria:

history of gastroesophageal reflux, High grade obesity, Predicted difficult airway, Asthma, Chronic obstructive pulmonary disease(COPD), Upper respiratory infection (URI) within 3 weeks

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Ajou University School of Medicine

Investigators

Study Chair: Yoonjeong Chae, MD, Ajou University School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jiyoung Yoo, clinical assistant professor, Ajou University School of Medicine

ClinicalTrials.gov Identifier:

NCT02379715

Other Study ID Numbers:

AJIRB-MED-CT4-14-327

First Posted:

Mar 5, 2015

Last Update Posted:

Aug 20, 2020

Last Verified:

Aug 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Jiyoung Yoo, clinical assistant professor, Ajou University School of Medicine

Remifentanil

smooth induction

desflurane

Additional relevant MeSH terms:

Remifentanil

Desflurane

Study Results

No Results Posted as of Aug 20, 2020