Deep Versus Moderate Neuromuscular Blocking

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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Pain Scores; Change in Serum Levels of the Estimated Inflammatory Cytokines; Total Dose of IO Fentanyl; PO Morphine; Surgeons' Rating
• Intervention / Treatment: Drug: Moderate Neuromuscular Blockade; Drug: Deep neuromuscular block

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.

• Study Type: Interventional
• Enrollment (Estimated): 88
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rabab Habeeb, MD; Phone Number: +201001970973; Email: rabab_habeeb@med.menofia.edu.eg

Study Locations

• Egypt
  • Eg.mn
    • Menoufia, Eg.mn, Egypt, 32511
      • Faculty of Medicine Menoufia University
      • Contact: Rabab Habeeb, MD; Phone Number: 01001970973; Email: rabab_habeeb@med.menofia.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: MNMB; rocuronium will be given as 0.2 mg/kg to maintain a post-tetanic count (PTC) of >1, and TOF in the range of	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.
Active Comparator: DNMB; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Menoufia University
• Investigators: Principal Investigator: Rabab M Habeeb, Faculty of Medicine Menoufia University

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: March 12, 2026
• First Submitted That Met QC Criteria: March 16, 2026
• First Posted (Actual): March 20, 2026

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: May 29, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: cytokines; Hysterectomy; Neuromuscular Blocking
• Other Study ID Numbers: 2/2026ANET2-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No