Effect of Magnesium Sulphate Pretreatment in Pediatric Abdominal Surgery

NCT05736744 | Recruiting Phase 2 DMC

• 1 other identifier: 04-2022-200028
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 2

Brief Summary

In this study, the investigators will compare the effect of magnesium sulphate pretreatment on the onset and duration of intense and deep neuromuscular Block of rocuronium versus Cis-Atracurium and on the period of no response to nerve stimulation in children undergoing elective open abdominal surgeries.

Conditions

Muscle Relaxation

Outcome Measures

Primary Outcomes (1)

• The time of no response to nerve stimulation (seconds)

  Neuromuscular monitoring will be performed using acceleromyography with the TOF-Watch SX (Organon Ireland Ltd, Dublin, Ireland). Period of no response will be defined as the time period with no response to TOF stimulation (intense and deep NMB).

  Intraoperative

Secondary Outcomes (3)

• Duration of deep NMB (seconds)

  Intraoperative

• The duration of moderate NMB (seconds)

  Intraoperative.

• NMB onset time (in seconds).

  Intraoperative.

Study Arms (2)

Cis/atracurium/saline placebo

PLACEBO COMPARATOR

1. The patients will receive 100 ml saline 0.9% at an infusion rate 5 ml/min-1) administered 20 min. before induction of anesthesia. 2. cisatracurium will be administered for intubation at a dose of 0.15 mg/kg IV and Maintenance at a dose of 0.03 mg/kg IV

Drug: Cis-Atracurium

Cis-Atracurium/MgSO4

ACTIVE COMPARATOR

1. The patients will be pretreated with magnesium sulphate infusion (30 mg kg-1, total volume 100 ml, infusion rate 5 ml min-1) 20 min. before induction of anesthesia. 2. Cis-Atracurium will be administered at 0.1-0.15 mg/kg IV bolus for intubation and maintenance at a dose of 0.03 mg/kg iv on fixed intervals.

Drug: MgSO4; Drug: Cis-Atracurium

Interventions

MgSO4 DRUG

The patients will be pretreated with magnesium sulphate infusion (30 mg kg-1, total volume 100 ml, infusion rate 5 ml min-1) 20 min. before induction of anesthesia.

Also known as: Magnesium Sulfate

Cis-Atracurium/MgSO4

Cis-Atracurium DRUG

Cis-Atracurium will be administered at 0.1-0.15 mg/kg IV bolus for intubation and maintenance at a dose of 0.03 mg/kg iv on fixed intervals.

Also known as: Nimbex

Cis-Atracurium/MgSO4; Cis/atracurium/saline placebo

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age group 2-12 years old
• Both genders
• Children who will be scheduled to undergo elective laparoscopic surgeries.
• Patients with American Society of Anesthesiologist physical status classification of 1 or 2-

You may not qualify if:

• Patients who are beyond the selected age group.
• Patients on medications that interfered with muscle activity.
• Allergy to medications used in this study.
• Neuro-muscular diseases.
• Renal or hepatic impairment.
• Hypermagnesemia (\>2.5 mmol) or hypomagnesemia (\<1.7 mmol).
• Parental refusal to participate in the study

Sponsors & Collaborators

• Assiut University: lead

Study Sites (2)

Pediatric hospital, faculty of medicine, Assiut university

Asyut, Assiut Governorate, 715715, Egypt

RECRUITING

Pediatric hospital

Asyut, Assiut Governorate, 715715, Egypt

RECRUITING

MeSH Terms

Interventions

Magnesium Sulfate; cisatracurium

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur 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

Heba S Hassan, Master

CONTACT

01146705556; hebaammar997@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The dose of the administered muscle relaxants will be given by an investigator not included in the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: To compare the effect of magnesium sulphate pretreatment on the onset and duration of intense and deep neuromuscular Block of rocuronium versus Cis-Atracurium and on the period of no response to nerve stimulation in children undergoing elective laparoscopic surgeries.

Study Record Dates

• First Submitted: January 20, 2023
• First Posted: February 21, 2023
• Study Start: June 20, 2023
• Primary Completion: February 20, 2025
• Study Completion: December 1, 2025
• Last Updated: January 20, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)