Change in Serum Levels of the Estimated Inflammatory CytokinesNCT07485517
Deep Versus Moderate Neuromuscular Blocking
A study testing Moderate Neuromuscular Blockade and Deep neuromuscular block in people with Change in Serum Levels of the Estimated Inflammatory Cytokines and Total Dose of IO Fentanyl, run by Menoufia University at 1 site in Egypt.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Change in Serum Levels of the Estimated Inflammatory Cytokines, Total Dose of IO Fentanyl, PO Morphine
- What is being tested?
- Moderate Neuromuscular Blockade and Deep neuromuscular block
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2026to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women who will be admitted to undergo elective hysterectomy
- ,-ASA grade I or II,
- Body mass index (BMI) of <35 kg/m2
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Medicine Menoufia University
Menoufia, Eg.mn, 32511
Rabab Habeeb, MD, 01001970973, rabab_habeeb@med.menofia.edu.eg
About this study
Official title: 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).
Read the 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.
- Conditions
- Change in Serum Levels of the Estimated Inflammatory Cytokines, Total Dose of IO Fentanyl, PO Morphine, Surgeons' Rating, Pain Scores
- Being tested
- Moderate Neuromuscular Blockade, Deep neuromuscular block
- Keywords
- Neuromuscular Blocking, Hysterectomy, cytokines
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Deep neuromuscular block |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
total dose of IO fentanyl in mg
Measured: Intraoperative period and first 24 hours postoperative
PO morphine
Post operative morphine consumption in mg
Measured: First 24 hours postoperative
Pain scores
Postoperative pain measured by visual analogue scale
Measured: 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
Measured: At the end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2026
- Study start1 Jun 2026
- Primary completion1 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Change in Serum Levels of the Estimated Inflammatory CytokinesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, rabab Mohammad habeeb, Menoufia University
- Investigators
- Rabab M Habeeb, Principal investigator, Faculty of Medicine Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07485517
- Sponsor's protocol ID
- 2/2026ANET2-2
- Status last verified
- Aug 2026
- First submitted
- 12 Mar 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Deep Versus Moderate Neuromuscular Blocking on Patients Undergoing Open Hysterectomy
- ClinicalTrials.gov ID
- NCT07485517
- Acronym / sponsor ID
- 2/2026ANET2-2
- Conditions
- Change in Serum Levels of the Estimated Inflammatory Cytokines, Total Dose of IO Fentanyl, PO Morphine, Surgeons' Rating, Pain Scores
- Keywords
- Neuromuscular Blocking, Hysterectomy, cytokines
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 20 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MNMB | Active comparator | Drug: Moderate Neuromuscular Blockaderocuronium will be given as 0.2 mg/kg to maintain a post-tetanic count (PTC) of >1, and TOF in the range of |
| DNMB | Active comparator | Drug: Deep neuromuscular blockrocuronium infusion was used to provide 0.48-0.72 mg/kg/h to maintain PTC 0-1 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Women who will be admitted to undergo elective hysterectomy
- ,-ASA grade I or II,
- Body mass index (BMI) of <35 kg/m2
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moderate Neuromuscular BlockadeA 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 | MNMB |
| Deep neuromuscular blockFor 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. | Drug | DNMB |
Primary outcome
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.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rabab M Habeeb principal investigator
Faculty of Medicine Menoufia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moderate Neuromuscular Blockade and Deep neuromuscular block in people with Change in Serum Levels of the Estimated Inflammatory Cytokines and Total Dose of IO Fentanyl, run by Menoufia University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rabab Habeeb, MD (+201001970973, rabab_habeeb@med.menofia.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.