Effect of MgSO4 Pretreatment on Muscle Relaxation (MgSO4/CisA)

Effect of Magnesium Sulphate Pretreatment on Cis-Atracurium Induced Neuromuscular Block and Recovery Characteristics: A Randomized Controlled Trial.

In this study, the effect of magnesium sulphate on the onset and duration of intense and moderate cis-atracurium induced neuromuscular blocking and on the period of no response to nerve stimulation will be evaluated in patients who will recieve magnesium sulphate (intervention group) and patients who will not recieve magnesium sulphate (comparator group).

Study Overview

• Status: Recruiting
• Conditions: Muscle Relaxation
• Intervention / Treatment: Drug: Magnesium Sulphate; Drug: Saline

Detailed Description

General anesthesia is a drug-induced reversible state consisting of unconsciousness, amnesia, anti-nociception, and immobility, with maintenance of physiological stability. Balanced general anesthesia, the most common management strategy used in anesthesia care, entails administering a combination of different agents to create the anesthetic state. There is evidence that balanced general anesthesia uses less of each drug than if the drug were administered alone. This approach is believed to increase the likelihood of a drug's desired effects and reduce the likelihood of its side effects. With addition of adjuvants, Alpha-2 adrenoceptor agonists, such as dexmedetomidine, are known to possess amnesic, analgesic, sympatholytic, and antinociceptive properties, and therefore, can reduce the requirement of anesthetics and opioids intraoperatively. Administration of MgSO4 has also shown significant reduction in the perioperative requirement of propofol, opioids, and muscle relaxants. Magnesium sulphate has gained prominence as an adjuvant drug in multimodal anesthesia and pain medicine. It has several clinical indications including attenuation of the adrenergic response to tracheal intubation and improved peri-operative analgesia. Magnesium sulphate also enhances the action of non-depolarizing neuromuscular blocking drugs, resulting in potentiation of neuromuscular blockade (NMB).The site of magnesium potentiation of neuromuscular blocking drugs is the motor end plate, where magnesium reduces the release of prejunctional acetylcholine, thereby decreasing the muscle membrane excitability. However, limited data exist concerning the effect of magnesium sulphate on the duration of deep or intense NMB and on the period of no response to nerve stimulation.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Hala S Abdel-Ghaffar, MD; Phone Number: +20 01003812011; Email: hallasaad@yahoo.com
• Study Contact Backup: Name: Abu El Hassan A Rezk, MBB Ch; Phone Number: +20 01026067713; Email: drhassanramadan96@gmail.com

Study Locations

• Egypt
  • Asyut Governorate
    • Asyut, Asyut Governorate, Egypt, 71515
      • Recruiting
      • Assiut university main hospital, ENT operative theatre
      • Contact: Hala S Abdel-Ghaffar, MD; Phone Number: +20 01003812011; Email: hallasaad@yahoo.com
      • Contact: Abu El Hassan A Rezk, MBBCh; Phone Number: +20 01026067713; Email: drhassanramadan96@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age group 18-60 years old
• Both genders
• Patients who will be scheduled to undergo elective otorhinolaryngological surgery.
• Patients with BMI between 18.5 and 24.9 Kg/m2.
• Patients with American Society of Anesthesiologist physical status classification of 1 or 2

Exclusion Criteria:

• Patients who are less than 18 years old or more than 60 years old.
• Patients on medications that interfered with muscle activity.
• Allergy to medications used in this study.
• Pregnancy or suspected pregnancy.
• Neuro-muscular diseases.
• Renal or hepatic impairment.
• Hypermagnesemia (>2.5 mmol) or hypomagnesemia (<1.7 mmol).
• Patients refusing to study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: MgSo4; A magnesium sulphate infusion (60 mg kg-1, total volume 100 ml, infusion rate 10 ml min-1) 10 min. will be administered before induction of anesthesia	Drug: Magnesium Sulphate; A magnesium sulphate infusion (60 mg kg-1, total volume 100 ml, infusion rate 10 ml min-1) will be administered to patients 10 min. before induction of anesthesia.; Other Names: MgSo4
Placebo Comparator: Saline Placebo; an intravenous 0.9% saline infusion (total volume 100 ml, infusion rate 10 ml min-1) 10 min. will be administered before induction of anesthesia.	Drug: Saline; The patients will be pretreated with an intravenous 0.9% saline infusion (total volume 100 ml, infusion rate 10 ml min-1) 10 min before induction of anesthesia.; Other Names: Placebo Comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The duration of the period of no response.	The effect of pretreatment with magnesium sulphate on the duration of the period of no response will be measured with the TOF-Watch SX (Organon Ireland Ltd, Dublin, Ireland). The ulnar nerve near the wrist will be stimulated and the activity of the adductor pollicis (thumb) muscle will be recorded.	Intraoperative.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The duration of intense neuromuscular block (minutes)	The effect of pretreatment with magnesium sulphate on the duration of the intense neuromuscular block in minutes will be measured with the TOF-Watch SX (Organon Ireland Ltd, Dublin, Ireland). The ulnar nerve near the wrist will be stimulated and the activity of the adductor pollicis (thumb) muscle will be recorded.	Intraoperative
The duration of deep neuromuscular block	The effect of pretreatment with magnesium sulphate on the duration of the deep neuromuscular block in minutes will be measured with the TOF-Watch SX (Organon Ireland Ltd, Dublin, Ireland). The ulnar nerve near the wrist will be stimulated and the activity of the adductor pollicis (thumb) muscle will be recorded.	Intraoperative.

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Principal Investigator: Hala Abdel-Ghaffar, MD, Professor of anesthesia and intensive care, faculty of medicine, Assiut university, Assiut, Egypt.

Study record dates

Study Major Dates

• Study Start (Actual): July 23, 2023
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: February 19, 2023
• First Submitted That Met QC Criteria: March 4, 2023
• First Posted (Actual): March 7, 2023

Study Record Updates

• Last Update Posted (Actual): July 1, 2024
• Last Update Submitted That Met QC Criteria: June 28, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: 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: 04-2023-200100

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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