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

NCT01923831 | Completed

• 1 other identifier: 4-2013-0385
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Operative Sore Throat

Keywords

Magnesium, Post operative sore throat, Prone position, Tracheal intubation

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• 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

Study Arms (2)

Magnesium group

EXPERIMENTAL

Drug: Magnesium Sulfate

Dexamethasone group

ACTIVE COMPARATOR

Drug: dexamethasone

Interventions

Magnesium Sulfate DRUG

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)

Magnesium group

dexamethasone DRUG

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)

Dexamethasone group

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine

Seoul, Seoul, 120-752, South Korea

Location

MeSH Terms

Interventions

Magnesium Sulfate; Dexamethasone

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Design

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

Study Record Dates

• First Submitted: August 5, 2013
• First Posted: August 16, 2013
• Study Start: August 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: March 17, 2015

Record last verified: 2015-03

Locations

KR (1)