Perioperative ComplicationPhase 4NCT05858957
Magnesium Sulphate and Extubation Quality
A Phase 4 study testing Magnesium sulfate and Saline in people with Perioperative Complication, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial summary
The investigators aimed to search effect of magnesium Sulfate on extubation quality scores, recovery and pain in larynx micro surgery. The patients allocated to two groups to receive magnesium sulfate 30 mg/kg in 100 ml saline infusion (maximum 2g) (Group m) or saline 100 ml (Group S) before induction of anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Perioperative Complication
- What is being tested?
- Magnesium sulfate and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Apr 2023to 30 Jul 2023
- Phase
- Phase 4
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 age over
- American society of Anesthesiology (ASA) clinical status I-III
- the patients who experience larynx micro surgery
Who cannot join
- under 18 years old
- ASA IV and over
- severe airway obstruction
- neuromuscular disease
- presence of tracheostomy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Magnesium Sulfate on Extubation Quality Score and Recovery in Larynx Laser Microsurgery, Prospective, Randomized, Controlled Study
The investigators aimed to search effect of magnesium Sulfate on extubation quality scores, recovery and pain in larynx micro surgery. The patients allocated to two groups to receive magnesium sulfate 30 mg/kg in 100 ml saline infusion (maximum 2g) (Group m) or saline 100 ml (Group S) before induction of anesthesia. Anesthesia induction performed with propofol 2 mg/kg, rocuronium 0.6 mg/kg, remifentanil 0.5 µg/kg and general anesthesia maintained with total intravenous anesthesia (propofol 3-7 mg/kg, remifentanil 0.05-0.1 µg/kg/min and O2/air 30/70 mixture) to the all patients. Extubation quality scores, Extubation time, NRS scores were assessed.
Read the detailed description
The investigators aimed to search effect of magnesium sulfate on extubation quality, recovery feature and complications.98 adult patients scheduled for larynx laser microsurgery were included and randomly allocated to two groups to receive magnesium sulfate 30 mg/kg in 100 ml saline infusion (maximum 2g) (Group m) or saline 100 ml (Group S) before induction of anesthesia. Anesthesia induction performed with propofol 2 mg/kg, rocuronium 0.6 mg/kg, remifentanil 0.5 µg/kg and general anesthesia maintained with total intravenous anesthesia (propofol 3-7 mg/kg, remifentanil 0.05-0.1 µg/kg/min and O2/air 30/70 mixture) to the all patients. Paracetamol 15 mg/kg applied to all patients.Extubation quality score, extubation time, stay in postanesthesia unit (PACU) time, numeric rating scale (NRS) and complications were recorded.
- Conditions
- Perioperative Complication
- Being tested
- Magnesium sulfate, Saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium sulfateDrug
Also called Intravenous magnesium infusion
magnesium sulphate IV 30 mg/kg (10 min) infusion apply to the Group M
SalineDrug
Also called Saline infusion
100 ml saline infusion apply to the Group S
| Study group | Role | What they receive |
|---|---|---|
| Magnesium | Experimental | Magnesium sulfate 30 mg/kg with 100 ml saline will apply in 10 min before induction of general anesthesia (maximum magnesium dose 2g) (Group M) . When the magnesium infusion completed, general anesthesia induction will start. Receives: Drug: Magnesium sulfate |
| Saline | Active comparator | saline 100 ml will apply in 10 min before induction of general anesthesia (Group S) . When the saline infusion completed, general anesthesia induction will start. Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
extubation quality scores
Extubation quality will assess with quality scores such as no cough, Mild cough, moderate cough, severe cough.
Measured: at the time between stop the total intravenous anesthesia and extubation of patient (last 20 min of anesthesia).
Secondary outcomes (1)
extubation time
The time need to adequate spontaneous ventilation at recovery period
Measured: time between stop the total intravenous anesthesia and extubation of patient (last 20 min of anesthesia).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2023
- Study start20 Apr 2023
- Primary completion15 Jul 2023
- Study completion30 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perioperative ComplicationStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ebru biricik, Cukurova University
- Investigators
- ebru biricik, Principal investigator, çukurova university faculty of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05858957
- Sponsor's protocol ID
- Extubation quality
- Status last verified
- Apr 2023
- First submitted
- 18 Apr 2023
- Last updated
- 17 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Magnesium Sulfate on Extubation Quality Score and Recovery in Larynx Laser Microsurgery, Prospective, Randomized, Controlled Study
- ClinicalTrials.gov ID
- NCT05858957
- Acronym / sponsor ID
- Extubation quality
- Conditions
- Perioperative Complication
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 20 Apr 2023 (actual)
- Primary completion
- 15 Jul 2023 (actual)
- Study completion
- 30 Jul 2023 (actual)
- First posted
- 15 May 2023 (actual)
- 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 investigators aimed to search effect of magnesium Sulfate on extubation quality scores, recovery and pain in larynx micro surgery. The patients allocated to two groups to receive magnesium sulfate 30 mg/kg in 100 ml saline infusion (maximum 2g) (Group m) or saline 100 ml (Group S) before induction of anesthesia. Anesthesia induction performed with propofol 2 mg/kg, rocuronium 0.6 mg/kg, remifentanil 0.5 µg/kg and general anesthesia maintained with total intravenous anesthesia (propofol 3-7 mg/kg, remifentanil 0.05-0.1 µg/kg/min and O2/air 30/70 mixture) to the all patients. Extubation quality scores, Extubation time, NRS scores were assessed.
Detailed description
The investigators aimed to search effect of magnesium sulfate on extubation quality, recovery feature and complications.98 adult patients scheduled for larynx laser microsurgery were included and randomly allocated to two groups to receive magnesium sulfate 30 mg/kg in 100 ml saline infusion (maximum 2g) (Group m) or saline 100 ml (Group S) before induction of anesthesia. Anesthesia induction performed with propofol 2 mg/kg, rocuronium 0.6 mg/kg, remifentanil 0.5 µg/kg and general anesthesia maintained with total intravenous anesthesia (propofol 3-7 mg/kg, remifentanil 0.05-0.1 µg/kg/min and O2/air 30/70 mixture) to the all patients. Paracetamol 15 mg/kg applied to all patients.Extubation quality score, extubation time, stay in postanesthesia unit (PACU) time, numeric rating scale (NRS) and complications were recorded.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Magnesium | Experimental | Drug: Magnesium sulfateMagnesium sulfate 30 mg/kg with 100 ml saline will apply in 10 min before induction of general anesthesia (maximum magnesium dose 2g) (Group M) . When the magnesium infusion completed, general anesthesia induction will start. |
| Saline | Active comparator | Drug: Salinesaline 100 ml will apply in 10 min before induction of general anesthesia (Group S) . When the saline infusion completed, general anesthesia induction will start. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 age over
- American society of Anesthesiology (ASA) clinical status I-III
- the patients who experience larynx micro surgery
Key exclusion criteria (5 listed)
- under 18 years old
- ASA IV and over
- severe airway obstruction
- neuromuscular disease
- presence of tracheostomy
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 sulfateAlso: Intravenous magnesium infusionmagnesium sulphate IV 30 mg/kg (10 min) infusion apply to the Group M | Drug | Magnesium |
| SalineAlso: Saline infusion100 ml saline infusion apply to the Group S | Drug | Saline |
Primary outcome
extubation quality scores
Time frame: at the time between stop the total intravenous anesthesia and extubation of patient (last 20 min of anesthesia).
Extubation quality will assess with quality scores such as no cough, Mild cough, moderate cough, severe cough.
1 secondary outcome
extubation time
Time frame: time between stop the total intravenous anesthesia and extubation of patient (last 20 min of anesthesia).
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 Jan 2024.
- Individual participant dataSharing planned: No
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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.
ebru biricik principal investigator
çukurova university faculty of medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Magnesium sulfate and Saline in people with Perioperative Complication, run by Cukurova University at 1 site in Turkey (Türkiye).
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 3 inclusion and 5 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 Jan 2024. 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 Turkey (Türkiye). 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
extubation quality scores (time frame: at the time between stop the total intravenous anesthesia and extubation of patient (last 20 min of anesthesia).). 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 Jan 2024.