Effect of MgSO4 Pretreatment on Muscle Relaxation

NCT ID: NCT05757999

Last Updated: 2024-07-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-23
• Study Completion Date: 2025-05-31

Brief 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).

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.

Conditions

Muscle Relaxation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Magnesium Sulphate

Intervention Type: DRUG

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 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.

Group Type: PLACEBO_COMPARATOR

Saline

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

MgSo4; Placebo Comparator

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Hala Saad Abdel-Ghaffar

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hala Abdel-Ghaffar, MD

Role: PRINCIPAL_INVESTIGATOR

Professor of anesthesia and intensive care, faculty of medicine, Assiut university, Assiut, Egypt.

Locations

Assiut university main hospital, ENT operative theatre

Asyut, Asyut Governorate, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Hala S Abdel-Ghaffar, MD

Role: CONTACT

hallasaad@yahoo.com

01003812011 ext. +20

Abu El Hassan A Rezk, MBB Ch

Role: CONTACT

drhassanramadan96@gmail.com

01026067713 ext. +20

Facility Contacts

Hala S Abdel-Ghaffar, MD

Role: primary

hallasaad@yahoo.com

01003812011 ext. +20

Abu El Hassan A Rezk, MBBCh

Role: backup

drhassanramadan96@gmail.com

01026067713 ext. +20

Other Identifiers

04-2023-200100

Identifier Type: -

Identifier Source: org_study_id