Change in Serum Levels of the Estimated Inflammatory Cytokines, Total Dose of IO Fentanyl, PO Morphine, Surgeons' Rating, Pain Scores
Conditions
Keywords
Neuromuscular Blocking, Hysterectomy, cytokines
Brief summary
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).
Detailed description
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.
Interventions
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.
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.
Sponsors
Menoufia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
No
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%, * the presence of neuromuscular disorders * uncontrolled medical diseases * autoimmune diseases, maintenance on immunosuppressant therapy for any indication * refusal to sign the written consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in serum levels of the estimated inflammatory cytokines | 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. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| total dose of IO fentanyl | Intraoperative period and first 24 hours postoperative | total dose of IO fentanyl in mg |
| PO morphine | First 24 hours postoperative | Post operative morphine consumption in mg |
| Pain scores | Immediately after recovery,2 hours,4,hours ,6 hours ,12 hours,24 hours postoperative | Postoperative pain measured by visual analogue scale |
| Surgeons satisfaction | At the end of surgery | the surgical condition will be described as excellent, good, acceptable, or poor, and will be rated on a 4-point scale |
Countries
Egypt
Contacts
CONTACTRabab Habeeb, MD
PRINCIPAL_INVESTIGATORRabab M Habeeb
Faculty of Medicine Menoufia University
Outcome results
None listed