The Effect Site Concentration of Remifentanil for Conscious Sedation During Awake Nasotracheal Fiberoptic Intubation - Full Text View

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:

MedlinePlus related topics: Cough Hernia Spinal Stenosis

Drug Information available for: Remifentanil hydrochloride

U.S. FDA Resources

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 [ Designated as safety issue: No ]

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:

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

Ages Eligible for Study:	20 Years to 65 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received:	January 11, 2010
Last Updated:	May 12, 2011
Health Authority:	Korea: Food and Drug Administration

Additional relevant MeSH terms:

Hernia
Spinal Stenosis
Intervertebral Disk Displacement
Pathological Conditions, Anatomical
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Remifentanil
Analgesics, Opioid
Analgesics
Sensory System Agents

Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics

ClinicalTrials.gov processed this record on May 23, 2013