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NCT Number: NCT05736744

Effect of Magnesium Sulphate Pretreatment in Pediatric Abdominal 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 open abdominal surgeries.

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Key information

Conditions

Age range

2 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Pediatric hospital, Asyut, Assiut Governorate, Egypt

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About this study

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 open abdominal surgeries.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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-

Exclusion criteria

  • 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

Treatment and study plan

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.

Other names: Magnesium Sulfate

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.

Other names: Nimbex

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Hala S Abdel-Ghaffar, MD

CONTACT

[email protected]

01003812011

Heba S Hassan, Master

CONTACT

[email protected]

01146705556

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Acronym: MgSO4/MR

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Feb 21, 2023
Registry last updated
Jan 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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