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

August 23, 2017 updated by: Keimyung University Dongsan Medical Center
This investigation is planned to compare the incidence and severity of postoperative sore throat according to the dose of remifentanil.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

92

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Non-US/Canada
      • Daegu, Non-US/Canada, Korea, Republic of, 137-040
        • Keimyung University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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 %.
Procedure: Endotracheal intubation using laryngoscope
Endotracheal intubation was done using laryngoscope for general anesthesia.
Drug: Low remifentanil
Remifentanil was administered as 0.1 mcg/kg/min.
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 %.
Experimental: 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.
Procedure: Endotracheal intubation using laryngoscope
Endotracheal intubation was done using laryngoscope for general anesthesia.
Drug: 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.
Drug: Low sevoflurane
Sevoflurane was administered as 0.5 MAC.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants with sore throat
Time Frame: At 24 hr
At 24 hr

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of participants with sore throat
Time Frame: At 0, 2, 4 and 24 hr
At 0, 2, 4 and 24 hr
Number of participants with hoarseness
Time Frame: At 0, 2, 4 and 24 hr
At 0, 2, 4 and 24 hr
Number of participants with cough
Time Frame: At 0, 2, 4 and 24 hr
At 0, 2, 4 and 24 hr
Number of participants with nausea
Time Frame: At 0, 2, 4 and 24 hr
At 0, 2, 4 and 24 hr
Number of participants with vomiting
Time Frame: At 0, 2, 4 and 24 hr
At 0, 2, 4 and 24 hr
Number of participants with additional pain medication
Time Frame: At 0, 2, 4 and 24 hr
At 0, 2, 4 and 24 hr
Visual analogue scale of postoperative pain
Time Frame: At 0, 2, 4 and 24 hr
At 0, 2, 4 and 24 hr
Number of participants with shivering
Time Frame: At 0, 2, 4 and 24 hr
At 0, 2, 4 and 24 hr
Requirements of analgesics
Time Frame: At 0, 2, 4 and 24 hr
At 0, 2, 4 and 24 hr

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Keimyung University Dongsan Medical Center

Investigators

  • Principal Investigator: Hyun-Chang Kim, MD. Ph. D., Keimyung University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2017

Primary Completion (Actual)

August 24, 2017

Study Completion (Actual)

August 24, 2017

Study Registration Dates

First Submitted

May 29, 2017

First Submitted That Met QC Criteria

May 30, 2017

First Posted (Actual)

June 1, 2017

Study Record Updates

Last Update Posted (Actual)

August 25, 2017

Last Update Submitted That Met QC Criteria

August 23, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HighRemiSoreThroat

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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