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

NCT ID: NCT01923831

Last Updated: 2015-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

146 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2014-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Post Operative Sore Throat

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Magnesium group

Group Type EXPERIMENTAL

Magnesium Sulfate

Intervention Type 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)

Dexamethasone group

Group Type ACTIVE_COMPARATOR

dexamethasone

Intervention Type 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)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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)

Intervention Type 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)

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Yonsei University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

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

Seoul, Seoul, South Korea

Site Status

Countries

Review the countries where the study has at least one active or historical site.

South Korea

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

4-2013-0385

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

High Dose Steroids for Dysphagia
NCT03256149 WITHDRAWN NA