Comparison of the Effect of Magnesium Sulfate and Dexamethasone on Postoperative Sore Throat After Spinal Surgery in Prone Position With Tracheal Intubation: a Double-blind, Randomized, Noninferiority Clinical Trial

Not Applicable

Completed

• Conditions: Post Operative Sore Throat
• Interventions: Drug: Magnesium Sulfate; Drug: dexamethasone

• Registration Number: NCT01923831
• Lead Sponsor: Yonsei University

Brief Summary

The purpose of this study is to compare the effect of magnesium sulfate and dexamethasone on postoperative sore throat after spinal surgery in prone position with tracheal intubation.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2013-08-05
• Study First Submitted QC: 2013-08-13
• Study First Posted: 2013-08-16
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-11
• Last Update Posted: 2015-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 146

Inclusion Criteria

• ASA I-II patients aged between 20 and 65 year undergoing 1 or 2 level posterior spinal fusion in prone position with tracheal intubation

Exclusion Criteria

• preexisting hoarseness or sore throat, upper respiratory tract infection
• steroid therapy or immunocompromised patients
• chronic treatment with calcium channel blocker or magnesium
• allergy to magnesium sulphate
• Cormack-Lehane grade 3,4 or patients who are expected to difficult intubation
• fail to tracheal intubation at first trial
• reduced kidney function
• Diabetes mellitus

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Magnesium group	Magnesium Sulfate	-
Dexamethasone group	dexamethasone	-

Primary Outcome Measures

Name	Time	Method
The effect of magnesium sulfate on postoperative sore throat after spinal surgery in prone position with tracheal intubation	Change of post operative sore throat level from 1 to 48 hours after surgery	Incidence of post operative sore throat Severity of post operative sore throat (10 cm-visual analogue scale ) Incidence of post operative hoarseness Severity of post operative hoarseness ( four-graded scale, 0= no hoarseness, 1= mild hoarseness, 2= severe hoarseness, 3= aphonia)

Secondary Outcome Measures

Name	Time	Method
The effect of dexamethasone on postoperative sore throat after spinal surgery in prone position with tracheal intubation	Change of post operative sore throat level from 1 to 48 hours after surgery	Incidence of post operative sore throat Severity of post operative sore throat (10 cm-visual analogue scale ) Incidence of post operative hoarseness Severity of post operative hoarseness ( four-graded scale, 0= no hoarseness, 1= mild hoarseness, 2= severe hoarseness, 3= aphonia)

Trial Locations

Locations (1)

Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of