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Magnesium Sulfate in Surgical Stress Attenuation Postoperative Sore Throat and Stress Response Induced Tracheal Intubation

Effect of Magnesium Sulfate Nebulization on Postoperative Sore Throat and Stress Response Induced Tracheal Intubation

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06091631
Acronym
Magnesium
Enrollment
100
Registered
2023-10-19
Start date
2023-11-15
Completion date
2025-02-28
Last updated
2025-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia Complication, Anesthesia Intubation Complication

Keywords

Magnesium sulfate, anesthesia stress response for intubation

Brief 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 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.

Interventions

PROCEDUREMagnesium sulfate vaporization

pre-opeative magnesium sulfate vaporization

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)

Masking description

the participant will not know whither a magnesium sulfate inhalation or distilled water in the vaporizer

Intervention 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

Eligibility

Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of post-operative sore throat at 0 hours in both groupsat 0 hours in both groupsIncidence of post-operative sore throat 0 h
Incidence of post-operative sore throat at 2 hours in both groupsat 2 hours in both groupsIncidence of post-operative sore throat 2 h
Incidence of post-operative sore throat at 4 hours in both groupsat 4 hours in both groupsIncidence of post-operative sore throat 4 h
Incidence of post-operative sore throat at 24 hours in both groupsat 24 hours in both groupsIncidence of post-operative sore throat 24 h

Secondary

MeasureTime frameDescription
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(3, 6) minutesImprovement 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
Effect on Pain score VAS 2hours after recovery2hours after recoveryEffect on Pain score VAS visual analogue scale.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026