Immune ResponsesNCT07870954
Comparative Study Between the Effects of Deep Versus Moderate Neuromuscular Blockade on Postoperative Recovery and Immune Function in Patients Undergoing Total Hip Replacement Surgery.
A study testing ToF ( Train of Four) Scan in people with Immune Responses and Post Operative Recovery, run by Sohag University at 1 site in Egypt.
Trial summary
. The investigators hypothesized that DNMB ( Deep NeuroMuscular Block) would yield superior postoperative recovery quality and attenuate the surgery-induced immune suppression compared to MNMB ( Moderate NeuroMuscular Block)in patients undergoing THA (Total Hip Arthroplasty). Read more about this study
- Who is it for?
- Ages 16 to 60 years
- Conditions the study is for
- Immune Responses, Post Operative Recovery
- What is being tested?
- ToF ( Train of Four) Scan
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jun 2026to 20 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 16 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Adult patients (ASA physical status I-III).
- Elective, primary THA under general anesthesia
Who cannot join
- Neuromuscular disease.
- Renal/hepatic impairment.
- Allergy to NMBAs or reversal agents.
- Pregnancy.
- Chronic opioid use.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mparative Study Between the Effects of Deep Versus Moderate Neuromuscular Blockade on Postoperative Recovery and Immune Function in Patients Undergoing Total Hip Replacement Surgery.( A Randomized Controlled Trial )
. The investigators hypothesized that DNMB ( Deep NeuroMuscular Block) would yield superior postoperative recovery quality and attenuate the surgery-induced immune suppression compared to MNMB ( Moderate NeuroMuscular Block)in patients undergoing THA (Total Hip Arthroplasty).
- Conditions
- Immune Responses, Post Operative Recovery
- Being tested
- ToF ( Train of Four) Scan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ToF ( Train of Four) ScanDevice
Depth of NMB will be monitored continuously using the ToFScan. The target NMB depth will be maintained until skin closure
| Study group | Role | What they receive |
|---|---|---|
| DNMB ( Deep NeuroMuscular Block) Group | Experimental | Not described Receives: Device: ToF ( Train of Four) Scan |
| MNMB ( Moderate NeuroMuscular Block) Group | Placebo comparator | Not described Receives: Device: ToF ( Train of Four) Scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Recovery-15 (QoR-15)
questionnaire score at 24 hours postoperatively with higher scores to be better outcomes
Measured: 24 hours post operative
Secondary outcomes (4)
Recovery Metrics
- Time to meet modified Aldrete score ≥9 in PACU.
Measured: immediately after surgery. With higher scores above 9 to be with better outcomes
Immune Functions
Measured: measured perioperatively ( preoperative and at 24/48 hours postoperatively) With higher scores above normal range for each indicates worse outcomes.
Innate immune function biomarkers
Measured: measured preoperatively and at 24/48 hours postoperatively
postoperative complications
Measured: 30 days post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study start20 Jun 2026
- Primary completion20 Nov 2026 (estimated)
- Study completion20 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune ResponsesStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Islam Mokhtar Ahmed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07870954
- Sponsor's protocol ID
- Soh-Med-26-6-13PD
- Status last verified
- Oct 2026
- First submitted
- 29 Aug 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- 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 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mparative Study Between the Effects of Deep Versus Moderate Neuromuscular Blockade on Postoperative Recovery and Immune Function in Patients Undergoing Total Hip Replacement Surgery.( A Randomized Controlled Trial )
- ClinicalTrials.gov ID
- NCT07870954
- Acronym / sponsor ID
- Soh-Med-26-6-13PD
- Conditions
- Immune Responses, Post Operative Recovery
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 20 Jun 2026 (actual)
- Primary completion
- 20 Nov 2026 (estimated)
- Study completion
- 20 Dec 2026 (estimated)
- First posted
- 13 Oct 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.
. The investigators hypothesized that DNMB ( Deep NeuroMuscular Block) would yield superior postoperative recovery quality and attenuate the surgery-induced immune suppression compared to MNMB ( Moderate NeuroMuscular Block)in patients undergoing THA (Total Hip Arthroplasty).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DNMB ( Deep NeuroMuscular Block) Group | Experimental | Device: ToF ( Train of Four) Scan |
| MNMB ( Moderate NeuroMuscular Block) Group | Placebo comparator | Device: ToF ( Train of Four) Scan |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Adult patients (ASA physical status I-III).
- Elective, primary THA under general anesthesia
Key exclusion criteria (5 listed)
- Neuromuscular disease.
- Renal/hepatic impairment.
- Allergy to NMBAs or reversal agents.
- Pregnancy.
- Chronic opioid use.
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 |
|---|---|---|
| ToF ( Train of Four) ScanDepth of NMB will be monitored continuously using the ToFScan. The target NMB depth will be maintained until skin closure | Device | DNMB ( Deep NeuroMuscular Block) Group, MNMB ( Moderate NeuroMuscular Block) Group |
Primary outcome
Quality of Recovery-15 (QoR-15)
Time frame: 24 hours post operative
questionnaire score at 24 hours postoperatively with higher scores to be better outcomes
4 secondary outcomes
Recovery Metrics
Time frame: immediately after surgery. With higher scores above 9 to be with better outcomes
Immune Functions
Time frame: measured perioperatively ( preoperative and at 24/48 hours postoperatively) With higher scores above normal range for each indicates worse outcomes.
Innate immune function biomarkers
Time frame: measured preoperatively and at 24/48 hours postoperatively
postoperative complications
Time frame: 30 days post operative
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 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ToF ( Train of Four) Scan in people with Immune Responses and Post Operative Recovery, run by Sohag 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 2 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: under way, not looking for participants, as of the sponsor's last update on 13 Oct 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. Some participants in this study may receive a placebo. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Recovery-15 (QoR-15) (time frame: 24 hours post operative). 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 Oct 2026.