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

NCT01052324 | Completed Phase 4 DMC

• 1 other identifier: 4-2009-0609
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Disc Herniation; Cervical Spinal Stenosis; Cervical Spine Damage

Outcome Measures

Primary Outcomes (1)

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

Interventions

Remifentanil DRUG

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 Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Severance Hospital

Seoul, South Korea

Location

MeSH Terms

Interventions

Remifentanil

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Yuen Hee Shim, MD, PhD

  Severance Hospital, Yonsei University College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Purpose: PREVENTION
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 11, 2010
• First Posted: January 20, 2010
• Study Start: March 1, 2010
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: May 13, 2011

Record last verified: 2011-05

Locations

KR (1)