Perioperative Diaphragmatic FunctionPhase 1NCT06982092
Using Diaphragm Ultrasonography, Sugammadex Recovers Diaphragmatic Function More Effectively Than Neostigmine.
A Phase 1 study testing sugammadex and Neostigmine in people with Perioperative Diaphragmatic Function, run by Ain Shams University at 1 site in Egypt.
Trial summary
The aim of our study is to assess differences in the recovery of muscle function, using diaphragm ultrasonography, after reversal of a rocuronium-induced block, using neostigmine versus sugammadex Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Perioperative Diaphragmatic Function
- What is being tested?
- sugammadex and Neostigmine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 26 Aug 2024to 15 Jan 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with American Society of Anesthesiologists' (ASA) physical status I or II or III
- Adult patients aging (18-65) years of both sexes. who undergoing deep neuromuscular block with rocuronium.
- Patients Scheduled for elective FISS surgery
Who cannot join
- Patient's refusal of procedure or participation in the study.
- ASA class IV.
- History of hepatic disease (Child Pugh B or C class).
- History of renal disease.
- Allergy or hypersensitivity to sugammadex or neostigmine.
- History of neuromuscular disease.
- Diaphragmatic palsy, pregnancy, nursing.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Effects of Neostigmine Versus Sugammadex in Ultrasonographic Evaluation of Recovery of Diaphragmatic Function After General Anesthesia
The aim of our study is to assess differences in the recovery of muscle function, using diaphragm ultrasonography, after reversal of a rocuronium-induced block, using neostigmine versus sugammadex
Read the detailed description
Post-operative residual curarization (PORC) remains an essential clinical challenge. The possibility of assessing muscle function and excluding PORC using noninvasive tools in the perioperative period is very attractive. Therefore, we used diaphragm ultrasonography.
The diaphragm is a major respiratory muscle, accounting for 60-70% of the respiratory workload. Its dysfunction involves post-operative respiratory failure.
Diaphragm ultrasound imaging is a cheap and portable technique that allows assessment of diaphragm thickness, thickening, and excursion at a point in time or over time, in ambulatory patients and in mechanically ventilated patients.
Acetylcholinesterase inhibitors can reverse muscle block, but their short half-life may lead to residual curarization in the ward, especially when intermediate or long-acting NMBAs have been administered. Sugammadex is the first selective reversal drug for steroidal NMBAs; it has been shown to give full and rapid recovery of muscle strength, thus minimizing the occurrence of residual curarization.
This study was designed to assess differences in the recovery of the diaphragmatic function, using diaphragm ultrasonography, after reversal of a rocuronium-induced block, using neostigmine versus sugammadex.
It was conducted to 60 patients of both sexes, scheduled for FESS surgeries who underwent deep neuromuscular block with rocuronium. Cases were aged 18-65 years, ASA physical status ІІ or III.
The patients were randomized by computer software randomization and divided into two equal groups; SUG group (n =30 patients) that received 2 mg/kg sugammadex and NEU group (n =30 patients) that received 50 mic/kg and 0.01-0.02 mg/kg atropine.
The following parameters were assessed and recorded; diaphragmatic thickening fraction, diaphragmatic excursion, number of patient with baseline diaphragmatic functionat 30min, spirometry volume, post extubation heart rate, respiratory rate, saturation, bronchospasm, nausea and vomiting.
- Conditions
- Perioperative Diaphragmatic Function
- Being tested
- sugammadex, Neostigmine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sugammadexDrug
Also called bridion
: patients will receive the reversal drug according to the group to which they had been randomised. in the Sugammadex Group will receive 2 mg/kg sugammadex.
NeostigmineDrug
Patients in the NEO Group will receive 50 mic/kg neostigmine and .01-.02 mg/kg atropine
| Study group | Role | What they receive |
|---|---|---|
| sugammadex | Active comparator | Group A: receive sugammadex (SUG group) as the reversal drug Receives: Drug: sugammadex |
| neostigmine | Active comparator | receive neostigmine (NEO group) as reversal drug. Receives: Drug: Neostigmine |
What is being measured
The primary outcome is the main question the study is designed to answer.
the difference between diaphragmatic thickening fraction at 30 minuets vs. The corresponding baseline values
Prior to induction of anesthesia, baseline thickening fractioning evaluated using diaphragmatic ultrasonography, All patients were given general anesthesia, after pre-oxygenation induction of anesthesia was started using fentanyl and propofol. Intubation was done with proper size endotracheal tube after relaxation provided by rocuronium, At the end the operation patients received the reversal drug according to the group to which they had been randomised.
Immediately prior to extubation, diaphragm ultrasonography was carried out to assess muscle recovery in each patient during spontaneous breathing. Two additional diaphragm ultrasound sessions were carried out 10 minutes and 30 minutes after discharge from the operating theatre, while the patients are in the post anesthesia care unit.
Measured: By using diaphragmatic ultrasonography baseline diaphragmatic thickening fraction preoperative and at Zero time, 10 minutes, and 30 minutes in Post anesthesia care unit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2025
- Study start26 Aug 2024
- Primary completion15 Jan 2025
- Study completion15 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perioperative Diaphragmatic FunctionStudies of the same condition, open and under way.
- More trials run by Ain Shams 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 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Interventional, parallel
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mostafa Hamed Mahmoud, M.B.B.CH, Principal investigator, Anesthesia resident Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06982092
- Sponsor's protocol ID
- FMASU MS535/2024
- Status last verified
- Mar 2025
- First submitted
- 4 Apr 2025
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data will be shared once study is completed
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Effects of Neostigmine Versus Sugammadex in Ultrasonographic Evaluation of Recovery of Diaphragmatic Function After General Anesthesia
- ClinicalTrials.gov ID
- NCT06982092
- Acronym / sponsor ID
- FMASU MS535/2024
- Conditions
- Perioperative Diaphragmatic Function
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 26 Aug 2024 (actual)
- Primary completion
- 15 Jan 2025 (actual)
- Study completion
- 15 Jan 2025 (actual)
- First posted
- 21 May 2025 (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 aim of our study is to assess differences in the recovery of muscle function, using diaphragm ultrasonography, after reversal of a rocuronium-induced block, using neostigmine versus sugammadex
Detailed description
Post-operative residual curarization (PORC) remains an essential clinical challenge. The possibility of assessing muscle function and excluding PORC using noninvasive tools in the perioperative period is very attractive. Therefore, we used diaphragm ultrasonography.
The diaphragm is a major respiratory muscle, accounting for 60-70% of the respiratory workload. Its dysfunction involves post-operative respiratory failure.
Diaphragm ultrasound imaging is a cheap and portable technique that allows assessment of diaphragm thickness, thickening, and excursion at a point in time or over time, in ambulatory patients and in mechanically ventilated patients.
Acetylcholinesterase inhibitors can reverse muscle block, but their short half-life may lead to residual curarization in the ward, especially when intermediate or long-acting NMBAs have been administered. Sugammadex is the first selective reversal drug for steroidal NMBAs; it has been shown to give full and rapid recovery of muscle strength, thus minimizing the occurrence of residual curarization.
This study was designed to assess differences in the recovery of the diaphragmatic function, using diaphragm ultrasonography, after reversal of a rocuronium-induced block, using neostigmine versus sugammadex.
It was conducted to 60 patients of both sexes, scheduled for FESS surgeries who underwent deep neuromuscular block with rocuronium. Cases were aged 18-65 years, ASA physical status ІІ or III.
The patients were randomized by computer software randomization and divided into two equal groups; SUG group (n =30 patients) that received 2 mg/kg sugammadex and NEU group (n =30 patients) that received 50 mic/kg and 0.01-0.02 mg/kg atropine.
The following parameters were assessed and recorded; diaphragmatic thickening fraction, diaphragmatic excursion, number of patient with baseline diaphragmatic functionat 30min, spirometry volume, post extubation heart rate, respiratory rate, saturation, bronchospasm, nausea and vomiting.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Interventional, parallel
| Arm | Type | Receives |
|---|---|---|
| sugammadex | Active comparator | Drug: sugammadexGroup A: receive sugammadex (SUG group) as the reversal drug |
| neostigmine | Active comparator | Drug: Neostigminereceive neostigmine (NEO group) as reversal drug. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with American Society of Anesthesiologists' (ASA) physical status I or II or III
- Adult patients aging (18-65) years of both sexes. who undergoing deep neuromuscular block with rocuronium.
- Patients Scheduled for elective FISS surgery
Key exclusion criteria (7 listed)
- Patient's refusal of procedure or participation in the study.
- ASA class IV.
- History of hepatic disease (Child Pugh B or C class).
- History of renal disease.
- Allergy or hypersensitivity to sugammadex or neostigmine.
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 |
|---|---|---|
| sugammadexAlso: bridion: patients will receive the reversal drug according to the group to which they had been randomised. in the Sugammadex Group will receive 2 mg/kg sugammadex. | Drug | sugammadex |
| NeostigminePatients in the NEO Group will receive 50 mic/kg neostigmine and .01-.02 mg/kg atropine | Drug | neostigmine |
Primary outcome
the difference between diaphragmatic thickening fraction at 30 minuets vs. The corresponding baseline values
Time frame: By using diaphragmatic ultrasonography baseline diaphragmatic thickening fraction preoperative and at Zero time, 10 minutes, and 30 minutes in Post anesthesia care unit
Prior to induction of anesthesia, baseline thickening fractioning evaluated using diaphragmatic ultrasonography, All patients were given general anesthesia, after pre-oxygenation induction of anesthesia was started using fentanyl and propofol. Intubation was done with proper size endotracheal tube after relaxation provided by rocuronium, At the end the operation patients received the reversal drug according to the group to which they had been randomised. Immediately prior to extubation, diaphragm ultrasonography was carried out to assess muscle recovery in each patient during spontaneous breathing. Two additional diaphragm ultrasound sessions were carried out 10 minutes and 30 minutes after discharge from the operating theatre, while the patients are in the post anesthesia care unit.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
- Individual participant dataSharing planned: Yes. All data will be shared once study is completed
Related trials for Perioperative Diaphragmatic Function
Not yet recruiting
Flow-Controlled vs. Pressure-Controlled Ventilation in CABG: Effects on Lung Aeration and Diaphragm Function
Coronary Artery Disease, Postoperative Pulmonary Complications
RecruitingObservational study
Diaphragm Ultrasound İn Children With OSAS
Obstructive Sleep Apnea of Child
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.
Mostafa Hamed Mahmoud, M.B.B.CH principal investigator
Anesthesia resident Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing sugammadex and Neostigmine in people with Perioperative Diaphragmatic Function, run by Ain Shams 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 7 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: finished, as of the sponsor's last update on 21 May 2025. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
the difference between diaphragmatic thickening fraction at 30 minuets vs. The corresponding baseline values (time frame: By using diaphragmatic ultrasonography baseline diaphragmatic thickening fraction preoperative and at Zero time, 10 minutes, and 30 minutes in Post anesthesia care unit). 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 21 May 2025.