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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cis/atracurium/saline placebo | Placebo Comparator |
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| Cis-Atracurium/MgSO4 | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| The duration of moderate NMB (seconds) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hala S Abdel-Ghaffar, MD | Contact | 01003812011 | hallasaad@yahoo.com | |
| Heba S Hassan, Master | Contact | 01146705556 | hebaammar997@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Hala Abdel-Ghaffar, MD | Professor of anesthesia and intensive care, faculty of medicine, Assiut university, Assiut, Egypt. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pediatric hospital, faculty of medicine, Assiut university | Recruiting | Asyut | Assiut Governorate | 715715 | Egypt |
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| ID | Term |
|---|---|
| D008278 | Magnesium Sulfate |
| C101584 | cisatracurium |
| ID | Term |
|---|---|
| D017616 | Magnesium Compounds |
| D007287 | Inorganic Chemicals |
| D013431 | Sulfates |
| D013464 | Sulfuric Acids |
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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.
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The dose of the administered muscle relaxants will be given by an investigator not included in the study.
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| 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. |
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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). | 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. |
| Pediatric hospital | Recruiting | Asyut | Assiut Governorate | 715715 | Egypt |
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| D013456 |
| Sulfur Acids |
| D013457 | Sulfur Compounds |