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This study aimed for Determination of the impacts of deep neuromuscular blockade (DNMB) on surgical outcomes, consumption of perioperative opioid analgesia, and serum levels of inflammatory cytokines in comparison to moderate NMB (MNMB).
The primary efficacy point is the extent of change in serum levels of the estimated inflammatory cytokines in PO samples relative to the preoperative levels. The secondary endpoints include the total dose of IO fentanyl and PO morphine, PO pain scores, and surgeons' rating of the surgical conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MNMB | Active Comparator | rocuronium will be given as 0.2 mg/kg to maintain a post-tetanic count (PTC) of >1, and TOF in the range of |
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| DNMB | Active Comparator | rocuronium infusion was used to provide 0.48-0.72 mg/kg/h to maintain PTC 0-1 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Moderate Neuromuscular Blockade | Drug | A TOF-Watch® SX-acceleromyograph will be applied to the adductor pollicis muscle and calibrated to monitor response and degree of NMB. Anesthesia will be induced with IV propofol (1.5-2.5 mg/kg) and rocuronium bromide 0.6 mg/Kg, and the trachea will be intubated at train-of-four (TOF) 0. Anesthesia will be maintained with 50% air in oxygen and an end-tidal concentration of 2-3% sevoflurane. In the DNMB group, rocuronium infusion was used to provide 0.48-0.72 mg/kg/h to maintain PTC 0-1. |
| Measure | Description | Time Frame |
|---|---|---|
| change in serum levels of the estimated inflammatory cytokines | The frozen serum samples will be used to estimate serum biomarkers via a quantitative sandwich enzyme-linked immunosorbent assay (ELISA) technique, and the results will be read using a 96-well microplate ELISA reader (Dynatech MR 7000). The studied biomarkers include serum tumor necrosis factor-α (TNF-α), interleukin (IL)-1β, and IL-6. | before induction of anesthesia and from the controls. Three PO samples (S2-4) will be obtained immediately at PACU admission, and 24 and 72 hours after surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| total dose of IO fentanyl | total dose of IO fentanyl in mg | Intraoperative period and first 24 hours postoperative |
| PO morphine | Post operative morphine consumption in mg |
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Inclusion Criteria:
Women who will be admitted to undergo elective hysterectomy
,-ASA grade I or II,
Body mass index (BMI) of <35 kg/m2
Exclusion Criteria:
hemoglobin concentration of ≤7 gm%,
Women who will be admitted to undergo elective hysterectomy,
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rabab Habeeb, MD | Contact | +201001970973 | rabab_habeeb@med.menofia.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Rabab M Habeeb | Faculty of Medicine Menoufia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine Menoufia University | Menoufia | Eg.mn | 32511 | Egypt |
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| Deep neuromuscular block | Drug | For patients in the MNMB group, rocuronium will be given as 0.2 mg/kg to maintain a post-tetanic count (PTC) of >1, and TOF in the range of 0-2. |
|
| First 24 hours postoperative |
| Pain scores | Postoperative pain measured by visual analogue scale | Immediately after recovery,2 hours,4,hours ,6 hours ,12 hours,24 hours postoperative |
| Surgeons satisfaction | the surgical condition will be described as excellent, good, acceptable, or poor, and will be rated on a 4-point scale | At the end of surgery |