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

Assiut University

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Muscle Relaxation

Treatments: Drug: Saline; Drug: Magnesium Sulphate

Study type: Interventional

Funder types: Other

Identifiers

NCT05757999

04-2023-200100

Details and patient eligibility

About

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).

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups, including a placebo group

MgSo4

Active Comparator group

Description:

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

Treatment:

Drug: Magnesium Sulphate

Saline Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Saline