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

NCT06091631 | Completed

• 1 other identifier: Attenuation of surgical stress
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia Complication; Anesthesia Intubation Complication

Keywords

Magnesium sulfate; anesthesia stress response for intubation

Outcome Measures

Primary Outcomes (4)

• 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 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

  (3, 6) minutes

• Effect on Pain score VAS 2hours after recovery

  2hours after recovery

Study Arms (2)

Magnesium sulfate

EXPERIMENTAL

will receive magnesium sulfate inhation

Procedure: Magnesium sulfate vaporization

Control

NO INTERVENTION

Will receive distilled water vaporization

Interventions

Magnesium sulfate vaporization PROCEDURE

pre-opeative magnesium sulfate vaporization

Magnesium sulfate

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• years old
• ASA: 1, 2
• 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 \> 40

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut university, faculty of medicine, anesthesia and ICU and pain management department

Asyut, Asyut Governorate, 71515, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: the participant will not know whither a magnesium sulfate inhalation or distilled water in the vaporizer
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Model Details: 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

Study Record Dates

• First Submitted: October 2, 2023
• First Posted: October 19, 2023
• Study Start: November 15, 2023
• Primary Completion: February 3, 2025
• Study Completion: February 28, 2025
• Last Updated: December 22, 2025

Record last verified: 2025-12

Locations

EG (1)