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CompletedNCT01052324Updated May 13, 2011

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

A Phase 4 interventional study of Remifentanil in Cervical Disc Herniation, Cervical Spinal Stenosis and Cervical Spine Damage, sponsored by Yonsei University. Completed at 1 site in Korea, Republic of. Open to participants aged 20 Years to 65 Years. Per ClinicalTrials.gov, last updated 2011-05-13.

Sponsored by Yonsei University · Phase 4, Interventional, and Prevention

Phase
Phase 4
Study type
Interventional
Enrollment
19
Ages
20 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Cervical Disc Herniation
  • Cervical Spinal Stenosis
  • Cervical Spine Damage
03

In context

Spinal Stenosis

459 studies on the registry are indexed under Spinal Stenosis; 103 are open to participants now.

This study's enrollment of 19 is below the median of 80 across 283 interventional studies indexed under Spinal Stenosis.

Browse Spinal Stenosis studies →

Lead sponsor

Yonsei University is the lead sponsor of 1,387 studies on the registry; 232 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Enrollment
19 participants (actual)

Interventions

  • DrugRemifentanil

    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.

06

What researchers measure

Primary outcomes

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

07

Study locations

1 site
  • Severance Hospital
    Seoul, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 13, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01052324
Lead sponsor
Yonsei University
First posted
Jan 20, 2010
Start date
Mar 2010
Primary completion
Nov 2010
Completion
Nov 2010
Last update
May 13, 2011

Study contacts

Yuen Hee Shim, MD, PhD
principal investigator · Severance Hospital, Yonsei University College of Medicine

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2011. You cannot join it, but the record below documents what was studied.

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