Effect of Magnesium Sulphate Pretreatment in Pediatric Laparoscopy (MgSO4/MR)

February 21, 2023 updated by: Hala Saad Abdel-Ghaffar, Assiut University

Effect of Magnesium Sulphate Pretreatment on the Onset and Duration of Intense and Deep Neuromuscular Block of Rocuronium Versus Cis-Atracurium in Pediatric Laparoscopic Surgery

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 laparoscopic surgeries.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Deep neuromuscular blockade is known to improve surgical conditions in procedures such as abdominal or pelvic laparoscopic surgery, laparotomy and laryngeal surgery. In addition, deep neuromuscular blockade enables a reduction in pneumoperitoneal pressure, postoperative pain and the incidence of intra-operative and postoperative adverse events. Correspondingly, the use of deep neuromuscular blockade is increasing, and for its maintenance neuromuscular monitoring is essential; the use of neostigmine may also be helpful in achieving a rapid recovery. 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. 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 laparoscopic surgeries.

Study Type

Interventional

Enrollment (Anticipated)

58

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
    • Assiut Governorate
      • Assiut, Assiut Governorate, Egypt, 715715
        • Pediatric Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Rocuronium/MgSO4
  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. Rocuronium will be administered for intubation at a dose of 0.45-0.6 mg/kg IV and Maintenance at a dose of 0.1-0.2 mg/kg IV on fixed interval
Drug: MgSO4
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.
Other Names:
  • Magnesium Sulfate
Drug: Rocuronium Bromide
Rocuronium will be administered for intubation at a dose of 0.45-0.6 mg/kg IV and Maintenance at a dose of 0.1-0.2 mg/kg IV on fixed interval
Other Names:
  • Esmeron
Active Comparator: Cis-Atracurium/MgSO4
  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
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.
Other Names:
  • Magnesium Sulfate
Drug: Cis-Atracurium
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.
Other Names:
  • Nimbex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The time of no response to nerve stimulation (seconds)
Time Frame: Intraoperative
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of deep NMB (seconds)
Time Frame: Intraoperative
The time period from the reappearance of the first response to PTC stimulation to the reappearance of the first response to TOF stimulation.
Intraoperative
The duration of moderate NMB (seconds)
Time Frame: Intraoperative.
the time period from the reappearance of the first response to PTC stimulation to the reappearance of the first response to TOF stimulation one to three out of four twitches.
Intraoperative.
NMB onset time (in seconds).
Time Frame: Intraoperative.
The time elapsed, in minutes, from the start of the administration of muscle relaxant; cis-atracurium or rocuronium injection to 95% of T1 depression.
Intraoperative.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Principal Investigator: Hala Abdel-Ghaffar, MD, Professor of anesthesia and intensive care, faculty of medicine, Assiut university, Assiut, Egypt.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 20, 2023

Primary Completion (Anticipated)

February 20, 2024

Study Completion (Anticipated)

December 1, 2024

Study Registration Dates

First Submitted

January 20, 2023

First Submitted That Met QC Criteria

February 10, 2023

First Posted (Actual)

February 21, 2023

Study Record Updates

Last Update Posted (Estimate)

February 23, 2023

Last Update Submitted That Met QC Criteria

February 21, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 04-2022-200028

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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