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CompletedNCT01240109Updated May 13, 2011

Effect of Remifentanil on Cough During Emergence From General Anesthesia : Trial to Compare Between Sevoflurane Anesthesia and Propofol Anesthesia

A Phase 4 interventional study of Remifentanil in Elective Thyroidectomy, sponsored by Yonsei University. Completed at 1 site in Korea, Republic of. Open to female participants aged 20 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-05-13.

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

Phase
Phase 4
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
20 Years to 70 Years
Sex
Female
01

Study summary

The objective of this study was to compare the effect of remifentanil on suppression cough reflex during emergence in patient anesthetized using either propofol or sevoflurane additionally under infusion of the identical concentration of remifentanil.

Read the detailed description

During recovery from general anesthesia the stimuli of endotracheal tube lead to the coughing, hypertension, tachycardia, which can cause a serious complication.

It has been demonstrated that opioid, intravenous or topical lidocaine administration can attenuate the coughing reflex.

Administered the opioid before emergence, it is effective to prevent cough reflex but the recovery is delayed, it was difficult to predict emergence.

However, remifentanil is an opioid widely used because of rapid context-sensitive half-life, target-controled infusion method to adequately maintain the effect site concentration could help to predict the recovery time to the alert state from the general anesthesia. It is considered proper method of continuous infusion of remifentanil for reducing emergence cough.

Recent reporters suggest that antitussive effect of remifentanil differs depend on main anesthetic agents, the incidence of coughing when tracheal extubation is reduced after propofol anesthesia compared with sevoflurane anesthesia.

However, these studies raise important questions about failure of maintaining the same effect site concentration of remifentanil in both groups.

The objective of this study was to compare the effect of remifentanil on suppression cough reflex during emergence in patient anesthetized using either propofol or sevoflurane additionally under infusion of the identical concentration of remifentanil.

During recovery from general anesthesia the stimuli of endotracheal tube lead to the coughing, hypertension, tachycardia, which can cause a serious complication.

It has been demonstrated that opioid, intravenous or topical lidocaine administration can attenuate the coughing reflex.

Administered the opioid before emergence, it is effective to prevent cough reflex but the recovery is delayed, it was difficult to predict emergence.

However, remifentanil is an opioid widely used because of rapid context-sensitive half-life, target-controled infusion method to adequately maintain the effect site concentration could help to predict the recovery time to the alert state from the general anesthesia. It is considered proper method of continuous infusion of remifentanil for reducing emergence cough.

Recent reporters suggest that antitussive effect of remifentanil differs depend on main anesthetic agents, the incidence of coughing when tracheal extubation is reduced after propofol anesthesia compared with sevoflurane anesthesia.

However, these studies raise important questions about failure of maintaining the same effect site concentration of remifentanil in both groups.

The objective of this study was to compare the effect of remifentanil on suppression cough reflex during emergence in patient anesthetized using either propofol or sevoflurane additionally under infusion of the identical concentration of remifentanil.

02

Conditions studied

  • Elective Thyroidectomy
03

In context

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 70 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • females
  • ASA I-II
  • aged between 20 and 70 year
  • general anesthesia for elective thyroidectomy

Exclusion criteria

Exclusion Criteria:

  • signs of an anatomical or functional abnormality in upper airway
  • risk factors for perioperative aspiration
  • smoking for recent 8 weeks
  • URI or sore throat for recent 2 weeks
  • potential of pregnancy
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
70 participants (actual)

Study arms

  • Active comparator
    propofol

    Drug: Remifentanil

  • Active comparator
    sevoflurane

    Drug: Remifentanil

Interventions

  • DrugRemifentanil

    * propofol group : propofol effect site-TCI 2-4mcg/ml + remifentanil effect site-TCI 2-4ng/ml * sevoflurane group: sevoflurane end-tidal concentration 0.5-1.0 MAC + remifentanil effect site-TCI 2-4ng/ml

    Also known as: Ultiva

06

Study locations

1 site
  • Severance Hospital
    Seoul, 120-752, Korea, Republic of
07

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 ↗
08

Registry details

Key details

Study ID
NCT01240109
Lead sponsor
Yonsei University
First posted
Nov 15, 2010
Start date
Sep 2010
Primary completion
Jan 2011
Completion
Feb 2011
Last update
May 13, 2011

Study contacts

Jeong-Rim Lee, MD, Ph.D
principal investigator · Severance Hospital, Department of Anesthesiology and Pain Medicine

Oversight

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

Not currently enrolling

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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