Anesthesia ComplicationMagnesiumNCT06091631
Magnesium Sulfate in Surgical Stress Attenuation Postoperative Sore Throat and Stress Response Induced Tracheal Intubation
A study testing Magnesium sulfate vaporization in people with Anesthesia Complication and Anesthesia Intubation Complication, run by Assiut University at 1 site in Egypt.
Trial summary
Magnesium sulfate has many mechanisms of action for attenuating the stress response as inhibition of catecholamine releasing from the adrenal medulla, keeping the plasma concentration of epinephrine at a fixed level, decreasing the circulating norepinephrine level when compared to that of a control group[ and also has… Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Anesthesia Complication, Anesthesia Intubation Complication
- What is being tested?
- Magnesium sulfate vaporization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Nov 2023to 28 Feb 2025
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 20-50 years old
- ASA: 1, 2
- Elective fit laparoscopic cholecystectomy
Who cannot join
- -Patient refusal
- patients with history of hypersensitivity to magnesium sulphate
- patients with coronary ischemic disease, atrioventricular block of any degree, known cardiac arrhythmias, heart failure
- on beta blockers or calcium channel blockers
- expected difficult intubation (Mallampati 4)
- Body mass index > 40
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Assiut university, faculty of medicine, anesthesia and ICU and pain management department
Asyut, Asyut Governorate, 71515
About this study
Official title: Effect of Magnesium Sulfate Nebulization on Postoperative Sore Throat and Stress Response Induced Tracheal Intubation
Magnesium sulfate has many mechanisms of action for attenuating the stress response as inhibition of catecholamine releasing from the adrenal medulla, keeping the plasma concentration of epinephrine at a fixed level, decreasing the circulating norepinephrine level when compared to that of a control group[ and also has a vasodilation effect on systemic and coronary blood vessels by blocking calcium ion in vascular smooth muscle.-Methyl- D-Aspartate (NMDA) antagonism is an amazing recent discovery for magnesium sulphate to play an important role in stress response.
In this study, we will study the effects of nebulized magnesium sulfate on hemodynamics during intubation.
Read the detailed description
Inclusion criteria
- 20-50 years old
- ASA: 1, 2
- Elective fit laparoscopic cholecystectomy Exclusion criteria
- Patient refusal
- patients with history of hypersensitivity to magnesium sulphate
- patients with coronary ischemic disease, atrioventricular block of any degree, known cardiac arrhythmias, heart failure
- on beta blockers or calcium channel blockers
- expected difficult intubation (Mallampati 4)
- Body mass index > 40
Study tools:
Following institutional ethical committee approval and written informed consent,a prospective randomized double-blinded study. After written informed consent wil be given, 100 patients, ASA 1 or 2, aged between 20 - 50 years, scheduled for elective surgery with Orotracheal Intubation (OTI) will be assessed for eligibility. Patients will be recruited in the study divided into two equal groups; Patients in Group A: will receive nebulized magnesium sulfate in 3 ml (240 mg) over 15 min, While group B: will receive nebulized normal saline in 3 ml over 15 min, ending 5 min before the induction of anesthesia. SBP, DBP, HR, and blood glucose level will be measured at the following intervals; Baseline (before induction), after premedication (sedation), after induction, after ETT intubation, 3 min later, 6 min later.
Full monitoring data (Blood pressure every 3 minutes, ECG, Nanogram, and pulse oximeter) wil be collected till 6 minutes then every 5 minutes. Random blood sugar will be tested 5 minutes pre-intubation, 3minutes and 5 minutes after intubation.
After end of nebulization, sedation with 2 mg midazolam and IV fluids (10 ml/kg) will be infused to avoid tachycardia of dehydration and fear of surgery. Then, we proceed on general anesthesia through propool titration + fentanyl 100 mcg + Cisatracurium 0.15 mg/kg. Endotracheal intubation with cuffed tube and mechanical ventilation with mild increase in respiratory rate 14-16/min to overcome CO2 peritoneal insufflation. All patients will receive intraoperatively, nalbuphine 0.1 mg/kg + ketorolac 60 mg + paracetamol IV 1 g. Dexamethasone 4mg + Ondansetron 4mg will be received to all patients for prophylaxis against postoperative nausea and vomiting. After end of surgery, cessation of inhalational anesthesia and reversal of muscle relaxation with neostigmine 2.5 mg+ Atropine 1mg will be done.
Consumption of isoflurane intraoperatively will be recorded. Post operative assessment for pain using VAS score will be assessed 2 hours after recovery.
Time for recovery after stop of isoflurane will be estimated.
- Being tested
- Magnesium sulfate vaporization
- Keywords
- Magnesium sulfate, anesthesia stress response for intubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium sulfate vaporizationProcedure or surgery
pre-opeative magnesium sulfate vaporization
| Study group | Role | What they receive |
|---|---|---|
| Magnesium sulfate | Experimental | will receive magnesium sulfate inhation Receives: Procedure: Magnesium sulfate vaporization |
| Control | No intervention | Will receive distilled water vaporization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of post-operative sore throat at 0 hours in both groups
Incidence of post-operative sore throat 0 h
Measured: at 0 hours in both groups
Incidence of post-operative sore throat at 2 hours in both groups
Incidence of post-operative sore throat 2 h
Measured: at 2 hours in both groups
Incidence of post-operative sore throat at 4 hours in both groups
Incidence of post-operative sore throat 4 h
Measured: at 4 hours in both groups
Incidence of post-operative sore throat at 24 hours in both groups
Incidence of post-operative sore throat 24 h
Measured: at 24 hours in both groups
Secondary outcomes (2)
Improvement in postoperative stress response after (3, 6) minutes including: • Heart rate > 20% baseline • Systolic and mean BP >25% baseline • Random blood sugar increase > 50 mg/dl from baseline
Improvement in postoperative stress response after (3, 6) minutes including:
- Heart rate > 20% baseline
- Systolic and mean BP >25% baseline
- Random blood sugar increase > 50 mg/dl from baseline
Measured: (3, 6) minutes
Effect on Pain score VAS 2hours after recovery
Effect on Pain score VAS visual analogue scale.
Measured: 2hours after recovery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2023
- Study start15 Nov 2023
- Primary completion3 Feb 2025
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia ComplicationStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2 groups are investigated. Each group consists of 50 patients. First group will receive magnesium sulfate inhalation . The other group will receive distilled water inhation
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayman Abd El-Khalek Mohammed Glala, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06091631
- Sponsor's protocol ID
- Attenuation of surgical stress
- Acronym
- Magnesium
- Status last verified
- Dec 2025
- First submitted
- 2 Oct 2023
- Last updated
- 22 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Magnesium Sulfate Nebulization on Postoperative Sore Throat and Stress Response Induced Tracheal Intubation
- ClinicalTrials.gov ID
- NCT06091631
- Acronym / sponsor ID
- Magnesium / Attenuation of surgical stress
- Keywords
- Magnesium sulfate, anesthesia stress response for intubation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Nov 2023 (actual)
- Primary completion
- 3 Feb 2025 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 19 Oct 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.
Magnesium sulfate has many mechanisms of action for attenuating the stress response as inhibition of catecholamine releasing from the adrenal medulla, keeping the plasma concentration of epinephrine at a fixed level, decreasing the circulating norepinephrine level when compared to that of a control group[ and also has a vasodilation effect on systemic and coronary blood vessels by blocking calcium ion in vascular smooth muscle.-Methyl- D-Aspartate (NMDA) antagonism is an amazing recent discovery for magnesium sulphate to play an important role in stress response.
In this study, we will study the effects of nebulized magnesium sulfate on hemodynamics during intubation.
Detailed description
Inclusion criteria
- 20-50 years old
- ASA: 1, 2
- Elective fit laparoscopic cholecystectomy Exclusion criteria
- Patient refusal
- patients with history of hypersensitivity to magnesium sulphate
- patients with coronary ischemic disease, atrioventricular block of any degree, known cardiac arrhythmias, heart failure
- on beta blockers or calcium channel blockers
- expected difficult intubation (Mallampati 4)
- Body mass index > 40
Study tools:
Following institutional ethical committee approval and written informed consent,a prospective randomized double-blinded study. After written informed consent wil be given, 100 patients, ASA 1 or 2, aged between 20 - 50 years, scheduled for elective surgery with Orotracheal Intubation (OTI) will be assessed for eligibility. Patients will be recruited in the study divided into two equal groups; Patients in Group A: will receive nebulized magnesium sulfate in 3 ml (240 mg) over 15 min, While group B: will receive nebulized normal saline in 3 ml over 15 min, ending 5 min before the induction of anesthesia. SBP, DBP, HR, and blood glucose level will be measured at the following intervals; Baseline (before induction), after premedication (sedation), after induction, after ETT intubation, 3 min later, 6 min later.
Full monitoring data (Blood pressure every 3 minutes, ECG, Nanogram, and pulse oximeter) wil be collected till 6 minutes then every 5 minutes. Random blood sugar will be tested 5 minutes pre-intubation, 3minutes and 5 minutes after intubation.
After end of nebulization, sedation with 2 mg midazolam and IV fluids (10 ml/kg) will be infused to avoid tachycardia of dehydration and fear of surgery. Then, we proceed on general anesthesia through propool titration + fentanyl 100 mcg + Cisatracurium 0.15 mg/kg. Endotracheal intubation with cuffed tube and mechanical ventilation with mild increase in respiratory rate 14-16/min to overcome CO2 peritoneal insufflation. All patients will receive intraoperatively, nalbuphine 0.1 mg/kg + ketorolac 60 mg + paracetamol IV 1 g. Dexamethasone 4mg + Ondansetron 4mg will be received to all patients for prophylaxis against postoperative nausea and vomiting. After end of surgery, cessation of inhalational anesthesia and reversal of muscle relaxation with neostigmine 2.5 mg+ Atropine 1mg will be done.
Consumption of isoflurane intraoperatively will be recorded. Post operative assessment for pain using VAS score will be assessed 2 hours after recovery.
Time for recovery after stop of isoflurane will be estimated.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 2 groups are investigated. Each group consists of 50 patients. First group will receive magnesium sulfate inhalation . The other group will receive distilled water inhation
| Arm | Type | Receives |
|---|---|---|
| Magnesium sulfate | Experimental | Procedure: Magnesium sulfate vaporizationwill receive magnesium sulfate inhation |
| Control | No intervention | –Will receive distilled water vaporization |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 20-50 years old
- ASA: 1, 2
- Elective fit laparoscopic cholecystectomy
Key exclusion criteria (6 listed)
- -Patient refusal
- patients with history of hypersensitivity to magnesium sulphate
- patients with coronary ischemic disease, atrioventricular block of any degree, known cardiac arrhythmias, heart failure
- on beta blockers or calcium channel blockers
- expected difficult intubation (Mallampati 4)
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 sulfate vaporizationpre-opeative magnesium sulfate vaporization | Procedure or surgery | Magnesium sulfate |
Primary outcome
Incidence of post-operative sore throat at 0 hours in both groups
Time frame: at 0 hours in both groups
Incidence of post-operative sore throat 0 h
Incidence of post-operative sore throat at 2 hours in both groups
Time frame: at 2 hours in both groups
Incidence of post-operative sore throat 2 h
Incidence of post-operative sore throat at 4 hours in both groups
Time frame: at 4 hours in both groups
Incidence of post-operative sore throat 4 h
Incidence of post-operative sore throat at 24 hours in both groups
Time frame: at 24 hours in both groups
Incidence of post-operative sore throat 24 h
2 secondary outcomes
Improvement in postoperative stress response after (3, 6) minutes including: • Heart rate > 20% baseline • Systolic and mean BP >25% baseline • Random blood sugar increase > 50 mg/dl from baseline
Time frame: (3, 6) minutes
Effect on Pain score VAS 2hours after recovery
Time frame: 2hours after recovery
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 22 Dec 2025.
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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 vaporization in people with Anesthesia Complication and Anesthesia Intubation Complication, run by Assiut University at 1 site in Egypt.
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 6 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 22 Dec 2025. 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 Egypt. 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?
Incidence of post-operative sore throat at 0 hours in both groups (time frame: at 0 hours in both groups). The study lists 4 primary outcomes in all. 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 22 Dec 2025.