Diaphragm UltrasoundPhase 1DTF/DE/AChENCT06787638
Effects of Neostigmine-dose on Diaphragmatic Dynamics
A Phase 1 study testing full dose of Neostigmine and half dose of Neostigmine in people with Diaphragm Ultrasound, run by Aswan University Hospital.
Trial summary
The goal of this Randomized Clinical Trial is to compare the postoperative diaphragmatic excursion between patients receiving half-dose neostigmine (0.04 mg/kg) and those receiving full-dose neostigmine (0.08 mg/kg) for neuromuscular blockade reversal. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Diaphragm Ultrasound
- What is being tested?
- full dose of Neostigmine and half dose of Neostigmine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 25 Jan 2025to Apr 2026
- Phase
- Phase 1
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults scheduled for elective laparoscopic cholecystectomy.
- Age: < or = 18 years.
- Both genders.
- American Society Of Anesthiologists (ASA) I/II patients.
- BMI <35
Who cannot join
- Pre-existing diaphragmatic or respiratory disorders.
- ASA III/IV
- BMI >35
- Chronic opioid use or abuse
- Pregnancy or breastfeeding
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Diaphragmatic Dynamics in Laparoscopic Cholecystectomy: Comparing Neuromuscular Blocker Reversal Strategies-A Randomized Trial
The goal of this Randomized Clinical Trial is to compare the postoperative diaphragmatic excursion between patients receiving half-dose neostigmine (0.04 mg/kg) and those receiving full-dose neostigmine (0.08 mg/kg) for neuromuscular blockade reversal.
The main questions it aims to answer are:
Read more
- Does half-dose neostigmine result in similar postoperative diaphragmatic excursion compared to full-dose neostigmine?
- Does half-dose neostigmine result in similar diaphragmatic thickening fraction compared to full-dose neostigmine? Researchers will compare patients receiving half-dose neostigmine to those receiving full-dose neostigmine to see if there are differences in postoperative diaphragmatic function, respiratory complications, and recovery.
Participants will:
- Undergo elective laparoscopic cholecystectomy.
- Receive either half-dose or full-dose neostigmine for neuromuscular blockade reversal.
Read the detailed description
Fifty patients from both genders scheduled for elective laparoscopic cholecystectomy were enrolled in this study to compare diaphragmatic assessment parameters.
Enrolled participants were randomly assigned to group A (patient receiving full dose of Neostigmine (0.08 mg/kg) plus Atropine (20 mic/kg)) or group B (patient receiving half dose of Neostigmine (0.04 mg/kg) plus Atropine (20 mic/kg)).
This is a prospective study that will be conducted at Aswan University Hospital.
Eligible participants will be adult patients (age ≥ 18 years) scheduled for elective laparoscopic cholecystectomy, with American Society of Anesthesiologists (ASA) physical status I or II, and a body mass index (BMI) < 35 kg/m². Patients with pre-existing diaphragmatic or respiratory disorders, ASA physical status III or IV, BMI > 35 kg/m², chronic opioid use or abuse, pregnancy, or breastfeeding will be excluded.
- Conditions
- Diaphragm Ultrasound
- Being tested
- full dose of Neostigmine, half dose of Neostigmine
- Keywords
- Diaphragmatic Thickening Fraction, Diaphragmatic Excursion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
full dose of NeostigmineDrug
- Group A: received 10ml (a full dose of Neostigmine (0.08 mg/kg) plus Atropine (20 mic/kg+7ml normal saline)
Measured using ultrasound Time frame: preoperatively and at zero, 10 minutes and 30 minutes postoperatively.
half dose of NeostigmineDrug
- Group B: received 10ml (a half dose of Neostigmine (0.04 mg/kg) plus Atropine (20 mic/kg+8ml normal saline).
Measured using ultrasound Time frame: preoperatively and at zero, 10 minutes and 30 minutes postoperatively.
| Study group | Role | What they receive |
|---|---|---|
| full dose of Neostigmine | Active comparator | Not described Receives: Drug: full dose of Neostigmine |
| half dose of Neostigmine | Active comparator | Not described Receives: Drug: half dose of Neostigmine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diaphragmatic Dynamics
To compare the postoperative diaphragmatic excursion between patients receiving half-dose neostigmine (0.04 mg/kg) and those receiving full-dose neostigmine (0.08 mg/kg) for neuromuscular blockade reversal.
Measured: preoperatively and at zero, 10 minutes and 30 minutes postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2025
- Study start25 Jan 2025 (estimated)
- Primary completionJan 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Diaphragm UltrasoundStudies 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 1
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aswan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Abd El Dayem Mohamed Abed, Aswan University Hospital
- Investigators
- Ayman M El-demirdash, Study chair, Anesthesia, surgical intensive care and pain management - Aswan University HospitalHani M Raslan, Study director, Anesthesia, surgical intensive care and pain management - Aswan University HospitalZaher Z Zaher, Study director, Anesthesia, surgical intensive care and pain management - Aswan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06787638
- Sponsor's protocol ID
- 944/7/24
- Acronym
- DTF/DE/AChE
- Status last verified
- Jan 2025
- First submitted
- 16 Jan 2025
- Last updated
- 22 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ayoub J, Cohendy R, Prioux J, Ahmaidi S, Bourgeois JM, Dauzat M, Ramonatxo M, Prefaut C. Diaphragm movement before and after cholecystectomy: a sonographic study. Anesth Analg. 2001 Mar;92(3):755-61. doi: 10.1097/00000539-200103000-00038.
PubMed 11226114Alam MJ, Roy S, Iktidar MA, Padma FK, Nipun KI, Chowdhury S, Nath RK, Rashid HO. Diaphragm ultrasound as a better predictor of successful extubation from mechanical ventilation than rapid shallow breathing index. Acute Crit Care. 2022 Feb;37(1):94-100. doi: 10.4266/acc.2021.01354. Epub 2022 Jan 11.
PubMed 35081706Adeyinka A, Layer DA. Neuromuscular Blocking Agents. 2024 Jun 8. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK537168/
PubMed 30725853
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diaphragmatic Dynamics in Laparoscopic Cholecystectomy: Comparing Neuromuscular Blocker Reversal Strategies-A Randomized Trial
- ClinicalTrials.gov ID
- NCT06787638
- Acronym / sponsor ID
- DTF/DE/AChE / 944/7/24
- Conditions
- Diaphragm Ultrasound
- Keywords
- Diaphragmatic Thickening Fraction, Diaphragmatic Excursion
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Aswan University HospitalUniversity, hospital or other
- Study start
- 25 Jan 2025 (estimated)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 22 Jan 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 goal of this Randomized Clinical Trial is to compare the postoperative diaphragmatic excursion between patients receiving half-dose neostigmine (0.04 mg/kg) and those receiving full-dose neostigmine (0.08 mg/kg) for neuromuscular blockade reversal.
The main questions it aims to answer are:
- Does half-dose neostigmine result in similar postoperative diaphragmatic excursion compared to full-dose neostigmine?
- Does half-dose neostigmine result in similar diaphragmatic thickening fraction compared to full-dose neostigmine? Researchers will compare patients receiving half-dose neostigmine to those receiving full-dose neostigmine to see if there are differences in postoperative diaphragmatic function, respiratory complications, and recovery.
Participants will:
- Undergo elective laparoscopic cholecystectomy.
- Receive either half-dose or full-dose neostigmine for neuromuscular blockade reversal.
Detailed description
Fifty patients from both genders scheduled for elective laparoscopic cholecystectomy were enrolled in this study to compare diaphragmatic assessment parameters.
Enrolled participants were randomly assigned to group A (patient receiving full dose of Neostigmine (0.08 mg/kg) plus Atropine (20 mic/kg)) or group B (patient receiving half dose of Neostigmine (0.04 mg/kg) plus Atropine (20 mic/kg)).
This is a prospective study that will be conducted at Aswan University Hospital.
Eligible participants will be adult patients (age ≥ 18 years) scheduled for elective laparoscopic cholecystectomy, with American Society of Anesthesiologists (ASA) physical status I or II, and a body mass index (BMI) < 35 kg/m². Patients with pre-existing diaphragmatic or respiratory disorders, ASA physical status III or IV, BMI > 35 kg/m², chronic opioid use or abuse, pregnancy, or breastfeeding will be excluded.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| full dose of Neostigmine | Active comparator | Drug: full dose of Neostigmine |
| half dose of Neostigmine | Active comparator | Drug: half dose of Neostigmine |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults scheduled for elective laparoscopic cholecystectomy.
- Age: < or = 18 years.
- Both genders.
- American Society Of Anesthiologists (ASA) I/II patients.
- BMI <35
Key exclusion criteria (5 listed)
- Pre-existing diaphragmatic or respiratory disorders.
- ASA III/IV
- BMI >35
- Chronic opioid use or abuse
- Pregnancy or breastfeeding
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 |
|---|---|---|
| full dose of Neostigmine• Group A: received 10ml (a full dose of Neostigmine (0.08 mg/kg) plus Atropine (20 mic/kg+7ml normal saline) Measured using ultrasound Time frame: preoperatively and at zero, 10 minutes and 30 minutes postoperatively. | Drug | full dose of Neostigmine |
| half dose of Neostigmine• Group B: received 10ml (a half dose of Neostigmine (0.04 mg/kg) plus Atropine (20 mic/kg+8ml normal saline). Measured using ultrasound Time frame: preoperatively and at zero, 10 minutes and 30 minutes postoperatively. | Drug | half dose of Neostigmine |
Primary outcome
Diaphragmatic Dynamics
Time frame: preoperatively and at zero, 10 minutes and 30 minutes postoperatively
To compare the postoperative diaphragmatic excursion between patients receiving half-dose neostigmine (0.04 mg/kg) and those receiving full-dose neostigmine (0.08 mg/kg) for neuromuscular blockade reversal.
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 22 Jan 2025.
- Background: PubMed 11226114Ayoub J, Cohendy R, Prioux J, Ahmaidi S, Bourgeois JM, Dauzat M, Ramonatxo M, Prefaut C. Diaphragm movement before and after cholecystectomy: a sonographic study. Anesth Analg. 2001 Mar;92(3):755-61. doi: 10.1097/00000539-200103000-00038.
- Background: PubMed 35081706Alam MJ, Roy S, Iktidar MA, Padma FK, Nipun KI, Chowdhury S, Nath RK, Rashid HO. Diaphragm ultrasound as a better predictor of successful extubation from mechanical ventilation than rapid shallow breathing index. Acute Crit Care. 2022 Feb;37(1):94-100. doi: 10.4266/acc.2021.01354. Epub 2022 Jan 11.
- Background: PubMed 30725853Adeyinka A, Layer DA. Neuromuscular Blocking Agents. 2024 Jun 8. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK537168/
- Individual participant dataSharing planned: No
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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.
Ayman M El-demirdash study chair
Anesthesia, surgical intensive care and pain management - Aswan University Hospital
Hani M Raslan study director
Anesthesia, surgical intensive care and pain management - Aswan University Hospital
Zaher Z Zaher study director
Anesthesia, surgical intensive care and pain management - Aswan University Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing full dose of Neostigmine and half dose of Neostigmine in people with Diaphragm Ultrasound, run by Aswan University Hospital.
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 5 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: opening soon, as of the sponsor's last update on 22 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
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 Sara A Mohamed (+201153006436, sara1704387@med.aswu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diaphragmatic Dynamics (time frame: preoperatively and at zero, 10 minutes and 30 minutes postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06787638, which also lists 3 linked publications.
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 22 Jan 2025.