A Postoperative Sore Throat After Lumbar Spine Surgery in the Prone Position

Not Applicable

• Conditions: Post Operative Sore Throat
• Interventions: Drug: remifentanil infusion; Drug: dexmedetomidine infusion

• Registration Number: NCT05345574
• Lead Sponsor: Yeungnam University College of Medicine

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-12-26
• Status Verified: 2022-04
• Study First Submitted: 2022-04-19
• Study First Submitted QC: 2022-04-19
• Last Update Submitted: 2022-04-19
• Study First Posted: 2022-04-26
• Last Update Posted: 2022-04-26
• Primary Completion: 2022-12-01
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 104

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
remifentanil infusion group	remifentanil infusion	remifentanil of 0.05 ㎍/kg/h during induction, followed by remifentanil infusion (0.05-0.3 ㎍/kg/h) during the surgery
dexmedetomidine infusion group	dexmedetomidine infusion	dexmedetomidine infusion (loading dose of 1 ㎍/kg over 10 min and continuous infusion of 0.3-0.6 ㎍/kg/h) during the surgery

Primary Outcome Measures

Name	Time	Method
incidence of postoperative sore throat at rest	1 hour after surgery	0=none; 1=occur
incidence of postoperative sore throat at swallowing	1 hour after surgery	0=none; 1=occur
severity of postoperative sore throat at rest	1 hour after surgery	4-point scale (0=none; 1=mild; 2=moderate; 3=severe)
severity of postoperative sore throat at swallowing	1 hour after surgery	4-point scale (0=none; 1=mild; 2=moderate; 3=severe)

Trial Locations

Locations (1)

Eun kyung Choi; 🇰🇷 Daegu, Korea (the Republic Of), Korea, Republic of