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NCT Number: NCT07485517

Deep Versus Moderate Neuromuscular Blocking

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).

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Key information

Conditions

Change in Serum Levels of the Estimated Inflammatory Cytokines PO Morphine Pain Scores Surgeons' Rating Total Dose of IO Fentanyl

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

    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 outcomes

  1. total dose of IO fentanyl

    Time frame: Intraoperative period and first 24 hours postoperative

    total dose of IO fentanyl in mg

  2. PO morphine

    Time frame: First 24 hours postoperative

    Post operative morphine consumption in mg

  3. Pain scores

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

    Postoperative pain measured by visual analogue scale

  4. Surgeons satisfaction

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Rabab Habeeb, MD

CONTACT

[email protected]

+201001970973

Sponsors and collaborators

Lead sponsor

Menoufia University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 20, 2026
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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