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

Cervical Disc Herniation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01052324
• Other study ID #: 4-2009-0609
• Status: Completed
• Phase: Phase 4
• First received: January 11, 2010
• Last updated: May 12, 2011
• Start date: March 2010
• Est. completion date: November 2010

Study information

• Verified date: May 2011
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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.

Study Design

Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cervical Disc Herniation
• Cervical Spinal Stenosis
• Cervical Spine Damage
• Intervertebral Disc Displacement
• Spinal Stenosis

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EC50 of remifentanil for preventing persistent cough and defensive movement using Dixon's up-and-down method			No