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

NCT ID: NCT01240109

Last Updated: 2011-05-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2011-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Elective Thyroidectomy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

propofol

Group Type ACTIVE_COMPARATOR

Remifentanil

Intervention Type DRUG

* 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

sevoflurane

Group Type ACTIVE_COMPARATOR

Remifentanil

Intervention Type DRUG

* 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Remifentanil

* 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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Ultiva

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Yonsei University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Severance Hospital, Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jeong-Rim Lee, MD, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Severance Hospital, Department of Anesthesiology and Pain Medicine

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Severance Hospital

Seoul, , South Korea

Site Status

Countries

Review the countries where the study has at least one active or historical site.

South Korea

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

4-2010-0369

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Comparison of Sevoflurane and Propofol on ANI
NCT06907823 NOT_YET_RECRUITING NA