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

Primary Purpose

Cervical Disc Herniation, Cervical Spinal Stenosis, Cervical Spine Damage

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Remifentanil
Sponsored by
Yonsei University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cervical Disc Herniation

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Severance Hospital

Outcomes

Primary Outcome Measures

EC50 of remifentanil for preventing persistent cough and defensive movement using Dixon's up-and-down method

Secondary Outcome Measures

Full Information

First Posted
January 11, 2010
Last Updated
May 12, 2011
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT01052324
Brief Title
The Effect Site Concentration of Remifentanil for Conscious Sedation During Awake Nasotracheal Fiberoptic Intubation
Official Title
The Effect Site Concentration of Remifentanil for Conscious Sedation During Awake Nasotracheal Fiberoptic Intubation
Study Type
Interventional

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Yonsei University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Disc Herniation, Cervical Spinal Stenosis, Cervical Spine Damage

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Remifentanil
Intervention Description
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.
Primary Outcome Measure Information:
Title
EC50 of remifentanil for preventing persistent cough and defensive movement using Dixon's up-and-down method

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuen Hee Shim, MD, PhD
Organizational Affiliation
Severance Hospital, Yonsei University College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Severance Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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