Effect of MgSO4 Pretreatment on Muscle Relaxation

NCT05757999 | Recruiting Phase 2 DMC

• 1 other identifier: 04-2023-200100
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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).

Conditions

Muscle Relaxation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• The duration of intense neuromuscular block (minutes)

  Intraoperative

• The duration of deep neuromuscular block

  Intraoperative.

Study Arms (2)

MgSo4

ACTIVE COMPARATOR

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

Saline Placebo

PLACEBO COMPARATOR

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

Interventions

Magnesium Sulphate 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.

Also known as: MgSo4

MgSo4

Saline 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.

Also known as: Placebo Comparator

Saline Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut university main hospital, ENT operative theatre

Asyut, Asyut Governorate, 71515, Egypt

RECRUITING

MeSH Terms

Interventions

Magnesium Sulfate; Sodium Chloride

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Sodium Compounds

Study Officials

• Hala Abdel-Ghaffar, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hala S Abdel-Ghaffar, MD

CONTACT

01003812011; hallasaad@yahoo.com

Abu El Hassan A Rezk, MBB Ch

CONTACT

01026067713; drhassanramadan96@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Allocation numbers will be placed in opaque envelopes and opened by an anesthesiologist (not participating in the study)who will also prepare the study solutions. The solutions used in the study are similar in physical appearance and an investigator not included in the study will prepare the solutions.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Patients will be allocated to one of two groups: a saline placebo group (n=50) or a magnesium group (n=50). The patients will be pretreated with either an intravenous 0.9% saline infusion (total volume 100 ml, infusion rate 10 ml min-1) or a magnesium sulphate infusion (60 mg kg-1, total volume 100 ml, infusion rate 10 ml min-1) 10 min. before induction of anesthesia. Allocation numbers will be placed in opaque envelopes and opened by an anesthesiologist (not participating in the study)who will also prepare the study solutions.

Study Record Dates

• First Submitted: February 19, 2023
• First Posted: March 7, 2023
• Study Start: July 23, 2023
• Primary Completion: April 1, 2025
• Study Completion: May 1, 2025
• Last Updated: July 1, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)