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Effect-site Concentration of Remifentanil for Smooth Induction With Desflurane

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ClinicalTrials.gov Identifier: NCT02379715
Recruitment Status : Completed
First Posted : March 5, 2015
Last Update Posted : August 18, 2015
Sponsor:
Information provided by (Responsible Party):
Jiyoung Yoo, Ajou University School of Medicine

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Official Title: Effect-site Concentration of Remifentanil for Smooth Induction With Desflurane
Study Start Date : December 2014
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine


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 Name: Ultiva

Drug: Desflurane



Primary Outcome Measures :
  1. Fail or success for induction with desflurane [ Time Frame: 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.



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Ages Eligible for Study:   19 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02379715


Sponsors and Collaborators
Ajou University School of Medicine
Investigators
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Study Chair: Yoonjeong Chae, MD Ajou University School of Medicine

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Responsible Party: Jiyoung Yoo, clinical assistant professor, Ajou University School of Medicine
ClinicalTrials.gov Identifier: NCT02379715     History of Changes
Other Study ID Numbers: AJIRB-MED-CT4-14-327
First Posted: March 5, 2015    Key Record Dates
Last Update Posted: August 18, 2015
Last Verified: August 2015
Keywords provided by Jiyoung Yoo, Ajou University School of Medicine:
Remifentanil
smooth induction
desflurane
Additional relevant MeSH terms:
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Remifentanil
Desflurane
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Inhalation
Anesthetics, General
Anesthetics