Menu
Not yet recruiting NCT07485517

Deep Versus Moderate Neuromuscular Blocking

No phase Interventional Change in Serum Levels of the Estimated Inflammatory Cytokines Total Dose of IO Fentanyl PO Morphine Surgeons' Rating

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Moderate Neuromuscular Blockade, Deep neuromuscular block.
Who it may be relevant to
Registry conditions: Change in Serum Levels of the Estimated Inflammatory Cytokines, Total Dose of IO Fentanyl, PO Morphine, Surgeons' Rating. Basic parameters: 18 years — 60 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

The Effect of Deep Versus Moderate Neuromuscular Blocking on Patients Undergoing Open Hysterectomy

Overview

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

  • Drug Moderate Neuromuscular Blockade
    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.
  • Drug Deep neuromuscular block
    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.

Primary outcome measures

  • change in serum levels of the estimated inflammatory cytokines [Time frame: 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.]
Secondary outcome measures (4)
  • total dose of IO fentanyl [Time frame: Intraoperative period and first 24 hours postoperative]
  • PO morphine [Time frame: First 24 hours postoperative]
  • Pain scores [Time frame: Immediately after recovery,2 hours,4,hours ,6 hours ,12 hours,24 hours postoperative]
  • Surgeons satisfaction [Time frame: At the end of surgery]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Faculty of Medicine Menoufia University — Menoufia

Identifiers

NCT: NCT07485517 · 2/2026ANET2-2

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗