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Deep Versus Moderate Neuromuscular Blocking

ConditionsChange in Serum Levels of the Estimated Inflammatory CytokinesTotal Dose of IO FentanylPO MorphineSurgeons' RatingPain Scores
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-60
SponsorMenoufia University

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Women who will be admitted to undergo elective hysterectomy

Body mass index (BMI) of <35 kg/m2

Disqualifiers

the presence of neuromuscular disorders

uncontrolled medical diseases

autoimmune diseases, maintenance on immunosuppressant therapy for any indication

refusal to sign the written consent

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

88 Participants
are divided into 2 treatment groups
Group A: MNMBActive comparator 1 intervention
Group B: DNMBActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

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 outcomes

1

total dose of IO fentanyl

total dose of IO fentanyl in mg

Time frame
Intraoperative period and first 24 hours postoperative
2

PO morphine

Post operative morphine consumption in mg

Time frame
First 24 hours postoperative
3

Pain scores

Postoperative pain measured by visual analogue scale

Time frame
Immediately after recovery,2 hours,4,hours ,6 hours ,12 hours,24 hours postoperative
4

Surgeons satisfaction

the surgical condition will be described as excellent, good, acceptable, or poor, and will be rated on a 4-point scale

Time frame
At the end of surgery

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Faculty of Medicine Menoufia UniversityRecruiting32511, Menoufia, Eg.mnEgyptEgypt

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Menoufia University

Lead sponsor

Source ClinicalTrials.gov
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