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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2010-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Cervical Disc Herniation Cervical Spinal Stenosis Cervical Spine Damage

Study Design

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Primary Study Purpose

PREVENTION

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No