NCT03173339

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 29, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 1, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

June 1, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 24, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 24, 2017

Completed
Last Updated

August 25, 2017

Status Verified

May 1, 2017

Enrollment Period

3 months

First QC Date

May 29, 2017

Last Update Submit

August 23, 2017

Conditions

Hip Arthroplasty

Keywords

intubationpharyngitisremifentanil

Outcome Measures

Primary Outcomes (1)

  • Number of participants with sore throat

    At 24 hr

Secondary Outcomes (9)

  • Number of participants with sore throat

    At 0, 2, 4 and 24 hr

  • Number of participants with hoarseness

    At 0, 2, 4 and 24 hr

  • Number of participants with cough

    At 0, 2, 4 and 24 hr

  • Number of participants with nausea

    At 0, 2, 4 and 24 hr

  • Number of participants with vomiting

    At 0, 2, 4 and 24 hr

  • +4 more secondary outcomes

Study Arms (2)

Low remifentanil and high sevoflurane

ACTIVE COMPARATOR

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 laryngoscopeDrug: Low remifentanilDrug: High sevoflurane

High remifentanil and low sevoflurane

EXPERIMENTAL

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 laryngoscopeDrug: High remifentanilDrug: Low sevoflurane

Interventions

Endotracheal intubation using laryngoscopePROCEDURE

Endotracheal intubation was done using laryngoscope for general anesthesia.

High remifentanil and low sevofluraneLow remifentanil and high sevoflurane
High remifentanilDRUG

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.

High remifentanil and low sevoflurane
Low remifentanilDRUG

Remifentanil was administered as 0.1 mcg/kg/min.

Low remifentanil and high sevoflurane
High sevofluraneDRUG

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 %.

Low remifentanil and high sevoflurane
Low sevofluraneDRUG

Sevoflurane was administered as 0.5 MAC.

High remifentanil and low sevoflurane

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Keimyung University

Daegu, Non-US/Canada, 137-040, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 30558006DERIVED

MeSH Terms

Conditions

Pharyngitis

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsPharyngeal DiseasesStomatognathic DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Hyun-Chang Kim, MD. Ph. D.

    Keimyung University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 29, 2017

First Posted

June 1, 2017

Study Start

June 1, 2017

Primary Completion

August 24, 2017

Study Completion

August 24, 2017

Last Updated

August 25, 2017

Record last verified: 2017-05

Locations

KR(1)