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The Effect Site Concentration of Remifentanil for Conscious Sedation During Awake Nasotracheal Fiberoptic Intubation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01052324
First Posted: January 20, 2010
Last Update Posted: May 13, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Yonsei University
  Purpose
Remifentanil provides analgesia, suppresses airway reflex, has little effect on cognitive function. It can be used for conscious sedation during awake nasotracheal fiberoptic intubation. Target-controlled infusion is more reliable technique for maintaining optimal infusion rate than manual controlled infusion. The aim of this study is to determine the effect site concentration of remifentanil for successful conscious sedation during awake nasotracheal fiberoptic intubation.

Condition Intervention Phase
Cervical Disc Herniation Cervical Spinal Stenosis Cervical Spine Damage Drug: Remifentanil Phase 4

Study Type: Interventional
Study Design: Primary Purpose: Prevention
Official Title: The Effect Site Concentration of Remifentanil for Conscious Sedation During Awake Nasotracheal Fiberoptic Intubation

Resource links provided by NLM:


Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • EC50 of remifentanil for preventing persistent cough and defensive movement using Dixon's up-and-down method

Enrollment: 19
Study Start Date: March 2010
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Remifentanil
    After topical airway anesthesia with 10 % lidocaine in nostril and oropharyx, 1.5~2.0 mg of IV midazolam is injected. Awake nasotracheal fiberoptic intubation is performed with target-controlled infusion of remifentanil. Initial effect site concentration is 3.0 ng/ml. Smooth intubation is defined as absence of persistent cough with head elevation and defensive movement of extremities. In case of smooth intubation, effect site concentration is decreased by 0.5 ng/ml for the subsequent case. If intubation is not smooth, effect site concentration is increased by 0.5 ng/ml for the subsequent case. EC50 of remifentanil is determined using Dixon's up-and-down method.
  Eligibility

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Ages Eligible for Study:   20 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients undergoing cervical spine surgery
  • Age 20-65
  • American Society of Anesthesiologists physical status classification I or II

Exclusion Criteria:

  • Patients' refusal
  • allergy to any drug used
  • unable to cooperate
  • Severe hepatic or renal disease
  • coagulation disorder
  • chronic use of opioids or sedatives
  • increase risk of pulmonary aspiration.
  Contacts and Locations
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): NCT01052324


Locations
Korea, Republic of
Severance Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Yonsei University
Investigators
Principal Investigator: Yuen Hee Shim, MD, PhD Severance Hospital, Yonsei University College of Medicine
  More Information

Responsible Party: Yuen Hee Shim, MD, PhD, Professor of Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Reseach Institute, Yonsei University College of Medicine, Seoul, Republic of Korea
ClinicalTrials.gov Identifier: NCT01052324     History of Changes
Other Study ID Numbers: 4-2009-0609
First Submitted: January 11, 2010
First Posted: January 20, 2010
Last Update Posted: May 13, 2011
Last Verified: May 2011

Additional relevant MeSH terms:
Spinal Stenosis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Remifentanil
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics