Post Operative Sore ThroatNCT01923831
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
A study testing Magnesium Sulfate and dexamethasone in people with Post Operative Sore Throat, run by Yonsei University at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Post Operative Sore Throat
- What is being tested?
- Magnesium Sulfate and dexamethasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2013to Sep 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I-II patients aged between 20 and 65 year undergoing 1 or 2 level posterior spinal fusion in prone position with tracheal intubation
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
Seoul, Seoul, 120-752
About this study
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
- Being tested
- Magnesium Sulfate, dexamethasone
- Keywords
- Magnesium, Post operative sore throat, Prone position, Tracheal intubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium SulfateDrug
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)
dexamethasoneDrug
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)
| Study group | Role | What they receive |
|---|---|---|
| Magnesium group | Experimental | Not described Receives: Drug: Magnesium Sulfate |
| Dexamethasone group | Active comparator | Not described Receives: Drug: dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
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)
Measured: Change of post operative sore throat level from 1 to 48 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative Sore ThroatStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01923831
- Sponsor's protocol ID
- 4-2013-0385
- Status last verified
- Mar 2015
- First submitted
- 5 Aug 2013
- Last updated
- 17 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01923831
- Acronym / sponsor ID
- 4-2013-0385
- Conditions
- Post Operative Sore Throat
- Keywords
- Magnesium, Post operative sore throat, Prone position, Tracheal intubation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 16 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Magnesium group | Experimental | Drug: Magnesium Sulfate |
| Dexamethasone group | Active comparator | Drug: dexamethasone |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ASA I-II patients aged between 20 and 65 year undergoing 1 or 2 level posterior spinal fusion in prone position with tracheal intubation
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnesium SulfateMagnesium 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) | Drug | Magnesium group |
| dexamethasoneNormal 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) | Drug | Dexamethasone group |
Primary outcome
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
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)
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnesium Sulfate and dexamethasone in people with Post Operative Sore Throat, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2015.