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Clinical Trials/NCT05345574
NCT05345574
Unknown
Not Applicable

The Effect of Dexmedetomidine and Remifentanil Infusion on Postoperative Sore Throat After Lumbar Spine Surgery in the Prone Position

Yeungnam University College of Medicine1 site in 1 country104 target enrollmentDecember 26, 2018

Overview

Phase
Not Applicable
Intervention
dexmedetomidine infusion
Conditions
Post Operative Sore Throat
Sponsor
Yeungnam University College of Medicine
Enrollment
104
Locations
1
Primary Endpoint
incidence of postoperative sore throat at rest
Last Updated
4 years ago

Overview

Brief Summary

This study was performed to compare the effect of dexmedetomidine and remifentanil on the incidence and severity of postoperative sore throat in patients undergoing spinal surgery in the prone position who are at risk of developing postoperative sore throat.

Registry
clinicaltrials.gov
Start Date
December 26, 2018
End Date
December 31, 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Eun Kyung Choi

Professor

Yeungnam University College of Medicine

Eligibility Criteria

Inclusion Criteria

  • American Society of Anesthesiologists (ASA) physical status classification I and II
  • Undergoing lumbar spine surgery in prone position

Exclusion Criteria

  • Pre-existing sore throat, hoarseness, or upper respiratory tract infection
  • Allergy to the study drugs
  • Anticipated difficult airways
  • More than two attempts at intubation

Arms & Interventions

dexmedetomidine infusion group

dexmedetomidine infusion (loading dose of 1 ㎍/kg over 10 min and continuous infusion of 0.3-0.6 ㎍/kg/h) during the surgery

Intervention: dexmedetomidine infusion

remifentanil infusion group

remifentanil of 0.05 ㎍/kg/h during induction, followed by remifentanil infusion (0.05-0.3 ㎍/kg/h) during the surgery

Intervention: remifentanil infusion

Outcomes

Primary Outcomes

incidence of postoperative sore throat at rest

Time Frame: 1 hour after surgery

0=none; 1=occur

incidence of postoperative sore throat at swallowing

Time Frame: 1 hour after surgery

0=none; 1=occur

severity of postoperative sore throat at rest

Time Frame: 1 hour after surgery

4-point scale (0=none; 1=mild; 2=moderate; 3=severe)

severity of postoperative sore throat at swallowing

Time Frame: 1 hour after surgery

4-point scale (0=none; 1=mild; 2=moderate; 3=severe)

Study Sites (1)

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