NCT07485517

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
3mo left

Started Feb 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress52%
Feb 2026Sep 2026

Study Start

First participant enrolled

February 1, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 12, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 20, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

March 20, 2026

Status Verified

March 1, 2026

Enrollment Period

6 months

First QC Date

March 12, 2026

Last Update Submit

March 16, 2026

Conditions

Change in Serum Levels of the Estimated Inflammatory CytokinesTotal Dose of IO FentanylPO MorphineSurgeons' RatingPain Scores

Keywords

Neuromuscular BlockingHysterectomycytokines

Outcome Measures

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.

    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 (4)

  • total dose of IO fentanyl

    Intraoperative period and first 24 hours postoperative

  • PO morphine

    First 24 hours postoperative

  • Pain scores

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

  • Surgeons satisfaction

    At the end of surgery

Study Arms (2)

MNMB

ACTIVE COMPARATOR

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

DNMB

ACTIVE COMPARATOR

rocuronium infusion was used to provide 0.48-0.72 mg/kg/h to maintain PTC 0-1

Drug: Deep neuromuscular block

Interventions

Moderate Neuromuscular BlockadeDRUG

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.

MNMB
Deep neuromuscular blockDRUG

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.

DNMB

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen who will be admitted to undergo elective hysterectomy,
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women who will be admitted to undergo elective hysterectomy
  • ,-ASA grade I or II,
  • Body mass index (BMI) of \<35 kg/m2

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine Menoufia University

Menoufia, Eg.mn, 32511, Egypt

RECRUITING

Study Officials

  • Rabab M Habeeb

    Faculty of Medicine Menoufia University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rabab Habeeb, MD

CONTACT

+201001970973rabab_habeeb@med.menofia.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

March 12, 2026

First Posted

March 20, 2026

Study Start

February 1, 2026

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

March 20, 2026

Record last verified: 2026-03

Locations

EG(1)