Sore ThroatNCT07123714
Effect of Nebulized Magnesium Sulfate on Post-intubation Stress Response in Patients Undergoing Laparoscopic Cholecystectomy
A study testing Nebulization of magnesium sulfate in people with Sore Throat, run by Assiut University.
Trial summary
This randomized controlled double blinded study will be carried out on 140 patients underwent elective fit laparoscopic cholecystectomy at El-Rajhi Assiut University Hospital. Inclusion criteria: 20-50 years old. Both sexes. American society of anesthesiologists (ASA) physical status I-II. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Sore Throat
- What is being tested?
- Nebulization of magnesium sulfate
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- 20 Aug 2025to 10 Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- American society of anesthesiologists (ASA) physical status I-II.
- 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 (BMI) > 40 kg/m2.
About this study
Official title: Effect of Preoperative Nebulized Magnesium Sulfate on Post-intubation Stress Response in Patients Undergoing Laparoscopic Cholecystectomy
This randomized controlled double blinded study will be carried out on 140 patients underwent elective fit laparoscopic cholecystectomy at El-Rajhi Assiut University Hospital.
Inclusion criteria:
Read more
- 20-50 years old.
- Both sexes.
- American society of anesthesiologists (ASA) physical status I-II.
- Elective fit laparoscopic cholecystectomy
Exclusion criteria:
- Patient refusal.
- Patients with history of hypersensitivity to magnesium sulfate.
- 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 (BMI) > 40 kg/m2.
An online randomization program (http://www.randomizer.org) will be used to generate a random list and each patients' code will be kept in an opaque sealed envelope. Patients will be randomly allocated with 1:1 allocation ratio into two equal groups in a parallel manner:
- Group A: (N=70) Patients will receive nebulized magnesium sulfate in 5 ml (250 mg) over 15 min.
- Group B: (N=70) Patients received nebulized normal saline in 5 ml over 15 min, ending 5 min before the induction of anesthesia.
- Preoperative assessment:
All patients will be subjected to the followings:
- Demographic data collection (age, weight, height, BMI, and ASA).
- Complete clinical examination.
- Routine Laboratory investigations:
- Random blood sugar.
- Blood sample withdrawal for cortisol level at baseline 2ml intravenously. The sample will be sent to be centrifugated within 30 minutes and the serum will be separated and stored in -20°C till time of cortisol level by ELIZA technique.
Read the detailed description
- Intraoperatively:
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) will 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 and recorded.
After end of nebulization, sedation with 2 mg midazolam and IV fluids (10 ml/kg) were infused to avoid tachycardia of dehydration and fear of surgery. Then, we proceed on general anesthesia through Propofol titration + fentanyl 100 mcg + Cis-atracurium 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 receive to all patients for prophylaxis against postoperative nausea and vomiting.
After 10 minutes of intubation, a second 2ml IV blood sample will be withdrawn for cortisol level. The centrifugation, serum separation, storage and ELIZA analysis will be done as the baseline sample described above.
- Postoperative:
After end of surgery, cessation of inhalational anesthesia and reversal of muscle relaxation with neostigmine 2.5 mg+ Atropine 1mg is done. Consumption of isoflurane intraoperatively is recorded. Post operative assessment for pain using Visual Analogue Scale (VAS) will be assessed 2 hours after recovery. VAS is presented as a website10 cm straight line ruler reflecting the extremes of "no pain" equals 0 and "worst pain at the other end(at 10cm), while in between the intensity of pain is represented by corresponding facies.
Time for recovery after stop of isoflurane is estimated. Hypertension is considered when the BP values are 20% above baseline values or SBP > 140 mmHg. Hypotension is considered when BP values are lower than 20% of baseline or SBP < 90 mmHg and will be treated with 10-20 mg ephedrine. Tachycardia will be considered when HR is higher than 20% of baseline or HR > 100 bpm. Bradycardia is considered when HR values are lower than 50 bpm, treated by I.V. atropine 0.02 mg/kg respiratory depression (the SpO2 < 95% and need O2 supplementation), and postoperative nausea and vomiting (PONV) is treated by ondansetron 0.1 mg/kg IV.
Measurements:
- Demographic data.
- Hemodynamics variables like SBP, DBP, HR, and blood glucose level are measured at the following intervals: Baseline (before induction), after premedication (sedation), after induction, after ETT intubation, 3 min later, 6 min later.
- Visual Analog Scale (VAS) is assessed.
- Side effects are recorded
- Conditions
- Sore Throat
- Being tested
- Nebulization of magnesium sulfate
- Keywords
- Magnesium sulfate nebulization, postoperative sore throat, Post-intubation sore throat, Post-intubation stress response
- Medical subject headings
- Pharyngitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nebulization of magnesium sulfateProcedure or surgery
patient will be nebulized with 5 mg magnesium sulfate (5 ml) 15 minutes before induction of anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Nebulized magnesium sulfate group | Experimental | Patients will receive nebulized magnesium sulfate in 5 ml (250 mg) over 15 min. Receives: Procedure: Nebulization of magnesium sulfate |
| control group | No intervention | Patients will receive nebulized normal saline 5ml, 15 minutes preoperatively |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between preoperative cortisol level and 6minutes after intubation
cortisol level will be measured preoperatively and 6 minutes after intubation then calculation of the difference between them then comparison between both groups
Measured: 6 minutes after intubation
Secondary outcomes (3)
NRS for sore throat postoperatively
Pain will be assessed by numeric rating scale NRS asking the patient about his degree of pain graded from 0 to 10 in which 0 refers to no pain at all and 10 refers to the worst pain experienced in life
Measured: 24 hours
4 grade scale
examination of the degree of laryngeal dysfunction due to sore throat into 4 grades: grade 1 refers to no pain, 2 refers to pain during swallowing, 3 =continuous pain and increases with swallowing and 4 refers to severe pain that hinders eating and necessitates urgent treatment.
Measured: 24 hours postoperatively
Random blood sugar RBS
RBS refers to stress and known to increase with stress
Measured: 6 minutes after intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2025
- Study start20 Aug 2025 (estimated)
- Primary completion1 Nov 2025 (estimated)
- Study completion10 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Sore ThroatStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 140 participants (estimated)
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
- NCT07123714
- Sponsor's protocol ID
- 17101959
- Status last verified
- Aug 2025
- First submitted
- 8 Aug 2025
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Yadav M, Chalumuru N, Gopinath R. Effect of magnesium sulfate nebulization on the incidence of postoperative sore throat. J Anaesthesiol Clin Pharmacol. 2016 Apr-Jun;32(2):168-71. doi: 10.4103/0970-9185.173367.
PubMed 272750432. Gutiérrez-Román, C.I., O. Carrillo-Torres and E.S. Pérez-Meléndez, Uses of magnesium sulfate in anesthesiology. Revista médica del Hospital General de México, 2022. 85(1): p. 25-33, .
Chen Z, Zuo Z, Zhang L, Gong M, Ye Y, Jin Y, Zhao X. Postoperative Sore Throat After Tracheal Intubation: An Updated Narrative Review and Call for Action. J Pain Res. 2025 May 6;18:2285-2306. doi: 10.2147/JPR.S498933. eCollection 2025.
PubMed 40352818
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Preoperative Nebulized Magnesium Sulfate on Post-intubation Stress Response in Patients Undergoing Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT07123714
- Acronym / sponsor ID
- 17101959
- Conditions
- Sore Throat
- Keywords
- Magnesium sulfate nebulization, postoperative sore throat, Post-intubation sore throat, Post-intubation stress response
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 Aug 2025 (estimated)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 10 Nov 2025 (estimated)
- First posted
- 14 Aug 2025 (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.
This randomized controlled double blinded study will be carried out on 140 patients underwent elective fit laparoscopic cholecystectomy at El-Rajhi Assiut University Hospital.
Inclusion criteria:
- 20-50 years old.
- Both sexes.
- American society of anesthesiologists (ASA) physical status I-II.
- Elective fit laparoscopic cholecystectomy
Exclusion criteria:
- Patient refusal.
- Patients with history of hypersensitivity to magnesium sulfate.
- 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 (BMI) > 40 kg/m2.
An online randomization program (http://www.randomizer.org) will be used to generate a random list and each patients' code will be kept in an opaque sealed envelope. Patients will be randomly allocated with 1:1 allocation ratio into two equal groups in a parallel manner:
- Group A: (N=70) Patients will receive nebulized magnesium sulfate in 5 ml (250 mg) over 15 min.
- Group B: (N=70) Patients received nebulized normal saline in 5 ml over 15 min, ending 5 min before the induction of anesthesia.
- Preoperative assessment:
All patients will be subjected to the followings:
- Demographic data collection (age, weight, height, BMI, and ASA).
- Complete clinical examination.
- Routine Laboratory investigations:
- Random blood sugar.
- Blood sample withdrawal for cortisol level at baseline 2ml intravenously. The sample will be sent to be centrifugated within 30 minutes and the serum will be separated and stored in -20°C till time of cortisol level by ELIZA technique.
Detailed description
- Intraoperatively:
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) will 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 and recorded.
After end of nebulization, sedation with 2 mg midazolam and IV fluids (10 ml/kg) were infused to avoid tachycardia of dehydration and fear of surgery. Then, we proceed on general anesthesia through Propofol titration + fentanyl 100 mcg + Cis-atracurium 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 receive to all patients for prophylaxis against postoperative nausea and vomiting.
After 10 minutes of intubation, a second 2ml IV blood sample will be withdrawn for cortisol level. The centrifugation, serum separation, storage and ELIZA analysis will be done as the baseline sample described above.
- Postoperative:
After end of surgery, cessation of inhalational anesthesia and reversal of muscle relaxation with neostigmine 2.5 mg+ Atropine 1mg is done. Consumption of isoflurane intraoperatively is recorded. Post operative assessment for pain using Visual Analogue Scale (VAS) will be assessed 2 hours after recovery. VAS is presented as a website10 cm straight line ruler reflecting the extremes of "no pain" equals 0 and "worst pain at the other end(at 10cm), while in between the intensity of pain is represented by corresponding facies.
Time for recovery after stop of isoflurane is estimated. Hypertension is considered when the BP values are 20% above baseline values or SBP > 140 mmHg. Hypotension is considered when BP values are lower than 20% of baseline or SBP < 90 mmHg and will be treated with 10-20 mg ephedrine. Tachycardia will be considered when HR is higher than 20% of baseline or HR > 100 bpm. Bradycardia is considered when HR values are lower than 50 bpm, treated by I.V. atropine 0.02 mg/kg respiratory depression (the SpO2 < 95% and need O2 supplementation), and postoperative nausea and vomiting (PONV) is treated by ondansetron 0.1 mg/kg IV.
Measurements:
- Demographic data.
- Hemodynamics variables like SBP, DBP, HR, and blood glucose level are measured at the following intervals: Baseline (before induction), after premedication (sedation), after induction, after ETT intubation, 3 min later, 6 min later.
- Visual Analog Scale (VAS) is assessed.
- Side effects are recorded
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nebulized magnesium sulfate group | Experimental | Procedure: Nebulization of magnesium sulfatePatients will receive nebulized magnesium sulfate in 5 ml (250 mg) over 15 min. |
| control group | No intervention | –Patients will receive nebulized normal saline 5ml, 15 minutes preoperatively |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- American society of anesthesiologists (ASA) physical status I-II.
- Elective fit laparoscopic cholecystectomy
Key exclusion criteria (4 listed)
- • Patient refusal.
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 |
|---|---|---|
| Nebulization of magnesium sulfatepatient will be nebulized with 5 mg magnesium sulfate (5 ml) 15 minutes before induction of anesthesia | Procedure or surgery | Nebulized magnesium sulfate group |
Primary outcome
Difference between preoperative cortisol level and 6minutes after intubation
Time frame: 6 minutes after intubation
cortisol level will be measured preoperatively and 6 minutes after intubation then calculation of the difference between them then comparison between both groups
3 secondary outcomes
NRS for sore throat postoperatively
Time frame: 24 hours
4 grade scale
Time frame: 24 hours postoperatively
Random blood sugar RBS
Time frame: 6 minutes after intubation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
- Background: PubMed 27275043Yadav M, Chalumuru N, Gopinath R. Effect of magnesium sulfate nebulization on the incidence of postoperative sore throat. J Anaesthesiol Clin Pharmacol. 2016 Apr-Jun;32(2):168-71. doi: 10.4103/0970-9185.173367.
- Background2. Gutiérrez-Román, C.I., O. Carrillo-Torres and E.S. Pérez-Meléndez, Uses of magnesium sulfate in anesthesiology. Revista médica del Hospital General de México, 2022. 85(1): p. 25-33, .
- Background: PubMed 40352818Chen Z, Zuo Z, Zhang L, Gong M, Ye Y, Jin Y, Zhao X. Postoperative Sore Throat After Tracheal Intubation: An Updated Narrative Review and Call for Action. J Pain Res. 2025 May 6;18:2285-2306. doi: 10.2147/JPR.S498933. eCollection 2025.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Nebulization of magnesium sulfate in people with Sore Throat, run by Assiut University.
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 2 inclusion and 4 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: opening soon, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Difference between preoperative cortisol level and 6minutes after intubation (time frame: 6 minutes after intubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07123714, which also lists 3 linked publications.
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 14 Aug 2025.