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

Post Operative Sore Throat Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01923831
• Other study ID #: 4-2013-0385
• Status: Completed
• Phase: N/A
• First received: August 5, 2013
• Last updated: March 11, 2015
• Start date: August 2013
• Est. completion date: September 2014

Study information

• Verified date: March 2015
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 146
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pharyngitis
• Post Operative Sore Throat

Intervention

Drug:
• Magnesium Sulfate
Magnesium sulfate 30 mg kg-1 was infused in 100mL normal saline for 10 minutes immediately before anesthesia induction. After tracheal intubation, normal saline 1.6mL ( equivalent volume as Dexamethasone 8mg) was injected, and magnesium sulfate was continuously infused at the rate of 10 mg Kg-1 h-1 until the end of surgery. (at the time of skin closure)
• dexamethasone
Normal saline 100mL was infused for 10 minutes immediately before anesthesia induction. After tracheal intubation, dexamethasone 8mg was injected, and normal saline was continuously infused at the rate of 10 mg Kg-1 h-1 until the end of surgery. (at the time of skin closure)

Locations

Country	Name	City	State
Korea, Republic of	Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The effect of magnesium sulfate on postoperative sore throat after spinal surgery in prone position with tracheal intubation	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)	Change of post operative sore throat level from 1 to 48 hours after surgery	No
Secondary	The effect of dexamethasone on postoperative sore throat after spinal surgery in prone position with tracheal intubation	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)	Change of post operative sore throat level from 1 to 48 hours after surgery	No