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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Yonsei University
Sponsor:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01923831
First received: August 5, 2013
Last updated: July 24, 2014
Last verified: August 2013
  Purpose

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.


Condition Intervention
Post Operative Sore Throat
Drug: Magnesium Sulfate
Drug: dexamethasone

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

Resource links provided by NLM:


Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • The effect of magnesium sulfate on postoperative sore throat after spinal surgery in prone position with tracheal intubation [ Time Frame: Change of post operative sore throat level from 1 to 48 hours after surgery ] [ Designated as safety issue: No ]
    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:
  • The effect of dexamethasone on postoperative sore throat after spinal surgery in prone position with tracheal intubation [ Time Frame: Change of post operative sore throat level from 1 to 48 hours after surgery ] [ Designated as safety issue: No ]
    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)


Estimated Enrollment: 146
Study Start Date: August 2013
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Magnesium group 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)
Active Comparator: Dexamethasone group Drug: 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)

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01923831

Contacts
Contact: Jong Wook Song, MD 82-2-2228-2420 SJW72331@yuhs.ac

Locations
Korea, Republic of
Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Jong Wook Song, MD    82-2-2228-2420    SJW72331@yuhs.ac   
Sponsors and Collaborators
Yonsei University
  More Information

No publications provided

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01923831     History of Changes
Other Study ID Numbers: 4-2013-0385
Study First Received: August 5, 2013
Last Updated: July 24, 2014
Health Authority: Korea: Institutional Review Board

Keywords provided by Yonsei University:
Magnesium, Post operative sore throat, Prone position, Tracheal intubation

Additional relevant MeSH terms:
Pharyngitis
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
Magnesium Sulfate
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Analgesics
Sensory System Agents

ClinicalTrials.gov processed this record on August 28, 2014