Effect of MgSO4 Pretreatment on Muscle Relaxation

Muscle Relaxation Clinical Trial

— MgSO4/CisA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05757999
• Other study ID #: 04-2023-200100
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: July 23, 2023
• Est. completion date: May 2024

Study information

• Verified date: July 2023
• Source: Assiut University
• Contact: Hala S Abdel-Ghaffar, MD
• Phone: 01003812011
• Email: hallasaad[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Muscle Relaxation

Intervention

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.
• Saline
The patients will be pretreated with either an intravenous 0.9% saline infusion (total volume 100 ml, infusion rate 10 ml min-1) 10 min. before induction of anesthesia.

Locations

Country	Name	City	State
Egypt	Assiut university main hospital, ENT operative theatre	Asyut	Asyut Governorate

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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.