Effect of Magnesium Sulphate Pretreatment in Pediatric Laparoscopy

Muscle Relaxation Clinical Trial

— MgSO4/MR  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05736744
• Other study ID #: 04-2022-200028
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• Start date: March 20, 2023
• Est. completion date: December 1, 2024

Study information

• Verified date: February 2023
• Source: Assiut University
• Contact: Hala S Abdel-Ghaffar, MD
• Phone: 01003812011
• Email: hallasaad[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 laparoscopic surgeries.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 58
• Est. completion date: December 1, 2024
• Est. primary completion date: February 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Muscle Relaxation

Intervention

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.
• 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
• 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.

Locations

Country	Name	City	State
Egypt	Pediatric hospital	Assiut	Assiut Governorate

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Duration of deep NMB (seconds)	The time period from the reappearance of the first response to PTC stimulation to the reappearance of the first response to TOF stimulation.	Intraoperative
Secondary	The duration of moderate NMB (seconds)	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.
Secondary	NMB onset time (in seconds).	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.