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

Primary Purpose

Hip Arthroplasty

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Endotracheal intubation using laryngoscope
High remifentanil
Low remifentanil
High sevoflurane
Low sevoflurane
Sponsored by
Keimyung University Dongsan Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hip Arthroplasty focused on measuring intubation, pharyngitis, remifentanil

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Keimyung University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Low remifentanil and high sevoflurane

High remifentanil and low sevoflurane

Arm Description

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 %.

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.

Outcomes

Primary Outcome Measures

Number of participants with sore throat

Secondary Outcome Measures

Number of participants with sore throat
Number of participants with hoarseness
Number of participants with cough
Number of participants with nausea
Number of participants with vomiting
Number of participants with additional pain medication
Visual analogue scale of postoperative pain
Number of participants with shivering
Requirements of analgesics

Full Information

First Posted
May 29, 2017
Last Updated
August 23, 2017
Sponsor
Keimyung University Dongsan Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03173339
Brief Title
Influence of Remifentanil on Postoperative Sore Throat in Patients Undergoing General Anesthesia
Official Title
Influence of Remifentanil on Postoperative Sore Throat in Patients Undergoing General Anesthesia
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
August 24, 2017 (Actual)
Study Completion Date
August 24, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Keimyung University Dongsan Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Arthroplasty
Keywords
intubation, pharyngitis, remifentanil

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
92 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low remifentanil and high sevoflurane
Arm Type
Active Comparator
Arm Description
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 %.
Arm Title
High remifentanil and low sevoflurane
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Endotracheal intubation using laryngoscope
Intervention Description
Endotracheal intubation was done using laryngoscope for general anesthesia.
Intervention Type
Drug
Intervention Name(s)
High remifentanil
Intervention Description
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
Intervention Name(s)
Low remifentanil
Intervention Description
Remifentanil was administered as 0.1 mcg/kg/min.
Intervention Type
Drug
Intervention Name(s)
High sevoflurane
Intervention Description
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
Intervention Name(s)
Low sevoflurane
Intervention Description
Sevoflurane was administered as 0.5 MAC.
Primary Outcome Measure Information:
Title
Number of participants with sore throat
Time Frame
At 24 hr
Secondary Outcome Measure Information:
Title
Number of participants with sore throat
Time Frame
At 0, 2, 4 and 24 hr
Title
Number of participants with hoarseness
Time Frame
At 0, 2, 4 and 24 hr
Title
Number of participants with cough
Time Frame
At 0, 2, 4 and 24 hr
Title
Number of participants with nausea
Time Frame
At 0, 2, 4 and 24 hr
Title
Number of participants with vomiting
Time Frame
At 0, 2, 4 and 24 hr
Title
Number of participants with additional pain medication
Time Frame
At 0, 2, 4 and 24 hr
Title
Visual analogue scale of postoperative pain
Time Frame
At 0, 2, 4 and 24 hr
Title
Number of participants with shivering
Time Frame
At 0, 2, 4 and 24 hr
Title
Requirements of analgesics
Time Frame
At 0, 2, 4 and 24 hr

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyun-Chang Kim, MD. Ph. D.
Organizational Affiliation
Keimyung University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Keimyung University
City
Daegu
State/Province
Non-US/Canada
ZIP/Postal Code
137-040
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
30558006
Citation
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.
Results Reference
derived

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

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