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

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.

Study Overview

• Status: Completed
• Conditions: Anesthesia Intubation Complication; Anesthesia Complication
• Intervention / Treatment: Procedure: Magnesium sulfate vaporization

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Asyut Governorate
    • Asyut, Asyut Governorate, Egypt, 71515
      • Assiut university, faculty of medicine, anesthesia and ICU and pain management department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Magnesium sulfate; will receive magnesium sulfate inhation	Procedure: Magnesium sulfate vaporization; pre-opeative magnesium sulfate vaporization
No Intervention: Control; Will receive distilled water vaporization

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of post-operative sore throat at 0 hours in both groups	Incidence of post-operative sore throat 0 h	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	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	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	at 24 hours in both groups

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	(3, 6) minutes
Effect on Pain score VAS 2hours after recovery	Effect on Pain score VAS visual analogue scale.	2hours after recovery

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2023
• Primary Completion (Actual): February 3, 2025
• Study Completion (Actual): February 28, 2025

Study Registration Dates

• First Submitted: October 2, 2023
• First Submitted That Met QC Criteria: October 14, 2023
• First Posted (Actual): October 19, 2023

Study Record Updates

• Last Update Posted (Actual): December 22, 2025
• Last Update Submitted That Met QC Criteria: December 17, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Magnesium sulfate; anesthesia stress response for intubation
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Pharyngitis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anticonvulsants; Calcium-Regulating Hormones and Agents; Reproductive Control Agents; Calcium Channel Blockers; Tocolytic Agents; Magnesium Sulfate
• Other Study ID Numbers: Attenuation of surgical stress

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No