Effect of Nebulized Magnesium Sulfate on Post-intubation Stress Response in Patients Undergoing Laparoscopic Cholecystectomy

NCT07123714 | Not Yet Recruiting DMC

• 1 other identifier: 17101959
• Study Type: interventional
• Target: 140
• Locations: 0 countries
• Sites: N/A

Brief 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.
• 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. A. 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.

Conditions

Sore Throat

Keywords

Magnesium sulfate nebulization; postoperative sore throat; Post-intubation sore throat; Post-intubation stress response

Outcome Measures

Primary Outcomes (1)

• 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

  6 minutes after intubation

Secondary Outcomes (3)

• NRS for sore throat postoperatively

  24 hours

• 4 grade scale

  24 hours postoperatively

• Random blood sugar RBS

  6 minutes after intubation

Study Arms (2)

Nebulized magnesium sulfate group

EXPERIMENTAL

Patients will receive nebulized magnesium sulfate in 5 ml (250 mg) over 15 min.

Procedure: Nebulization of magnesium sulfate

control group

NO INTERVENTION

Patients will receive nebulized normal saline 5ml, 15 minutes preoperatively

Interventions

Nebulization of magnesium sulfate PROCEDURE

patient will be nebulized with 5 mg magnesium sulfate (5 ml) 15 minutes before induction of anesthesia

Nebulized magnesium sulfate group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American society of anesthesiologists (ASA) physical status I-II.
• Elective fit laparoscopic cholecystectomy

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (3)

• 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.

  PMID: 27275043 BACKGROUND

• 2. 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

• 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.

  PMID: 40352818 BACKGROUND

MeSH Terms

Conditions

Pharyngitis

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: August 8, 2025
• First Posted: August 14, 2025
• Study Start: August 20, 2025
• Primary Completion: November 1, 2025
• Study Completion: November 10, 2025
• Last Updated: August 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share