Influence of Remifentanil on Postoperative Sore Throat in Patients Undergoing General Anesthesia

NCT ID: NCT03173339

Last Updated: 2017-08-25

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

NA

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-01

Study Completion Date

2017-08-24

Brief Summary

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

This investigation is planned to compare the incidence and severity of postoperative sore throat according to the dose of remifentanil.

Detailed Description

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

Conditions

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

Hip Arthroplasty

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

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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

Low remifentanil and high sevoflurane

Remifentanil was administered as 0.1 mcg/kg/min. Sevoflurane was started as 0.5 MAC. Sevoflurane dose was adjusted to maintain blood pressure (20% of preoperative blood pressure) and bispectral index (40-60) by 0.2 %.

Group Type ACTIVE_COMPARATOR

Endotracheal intubation using laryngoscope

Intervention Type PROCEDURE

Endotracheal intubation was done using laryngoscope for general anesthesia.

Low remifentanil

Intervention Type DRUG

Remifentanil was administered as 0.1 mcg/kg/min.

High sevoflurane

Intervention Type DRUG

Sevoflurane was started as 0.5 MAC. Sevoflurane dose was adjusted to maintain blood pressure (20% of preoperative blood pressure) and bispectral index (40-60) by 0.2 %.

High remifentanil and low sevoflurane

Sevoflurane was administered as 0.5 MAC. Remifentanil was started as 0.25 mcg/kg/min. Remifentanil dose was adjusted to maintain blood pressure (20% of preoperative blood pressure) and bispectral index (40-60) by 0.05 mcg/kg/min.

Group Type EXPERIMENTAL

Endotracheal intubation using laryngoscope

Intervention Type PROCEDURE

Endotracheal intubation was done using laryngoscope for general anesthesia.

High remifentanil

Intervention Type DRUG

Remifentanil was started as 0.25 mcg/kg/min. Remifentanil dose was adjusted to maintain blood pressure (20% of preoperative blood pressure) and bispectral index (40-60) by 0.05 mcg/kg/min.

Low sevoflurane

Intervention Type DRUG

Sevoflurane was administered as 0.5 MAC.

Interventions

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

Endotracheal intubation using laryngoscope

Endotracheal intubation was done using laryngoscope for general anesthesia.

Intervention Type PROCEDURE

High remifentanil

Remifentanil was started as 0.25 mcg/kg/min. Remifentanil dose was adjusted to maintain blood pressure (20% of preoperative blood pressure) and bispectral index (40-60) by 0.05 mcg/kg/min.

Intervention Type DRUG

Low remifentanil

Remifentanil was administered as 0.1 mcg/kg/min.

Intervention Type DRUG

High sevoflurane

Sevoflurane was started as 0.5 MAC. Sevoflurane dose was adjusted to maintain blood pressure (20% of preoperative blood pressure) and bispectral index (40-60) by 0.2 %.

Intervention Type DRUG

Low sevoflurane

Sevoflurane was administered as 0.5 MAC.

Intervention Type DRUG

Eligibility Criteria

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

Inclusion Criteria

* ASA I-III
* Patients scheduled for general anesthesia with endotracheal intubation

Exclusion Criteria

* Difficult airway
* Rapid sequence induction
* Recent sore throat
* Recent upper respiratory infection
* Asthma
* Chronic obstructive pulmonary disease
* Chronic cough
* Pregnancy
* Allergy to remifentanil
* Friable teeth
* History of head and neck surgery
* Multiple intubation attempts
* Regional anesthetic agents
* Gastric tube
* Dexamethasone
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

Keimyung University Dongsan Medical Center

OTHER

Sponsor Role lead

Responsible Party

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

Responsibility Role SPONSOR

Principal Investigators

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

Hyun-Chang Kim, MD. Ph. D.

Role: PRINCIPAL_INVESTIGATOR

Keimyung University

Locations

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

Keimyung University

Daegu, Non-US/Canada, South Korea

Site Status

Countries

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

South Korea

References

Explore related publications, articles, or registry entries linked to this study.

Park JH, Lee YC, Lee J, Kim H, Kim HC. The influence of high-dose intraoperative remifentanil on postoperative sore throat: a prospective randomized study: A CONSORT compliant article. Medicine (Baltimore). 2018 Dec;97(50):e13510. doi: 10.1097/MD.0000000000013510.

Reference Type DERIVED
PMID: 30558006 (View on PubMed)

Other Identifiers

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

HighRemiSoreThroat

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

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