Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE1
50 participants
INTERVENTIONAL
2025-01-25
2026-04-30
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
TRIPLE
Study Groups
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full dose of Neostigmine
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.
half 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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* Age: \< or = 18 years.
* Both genders.
* American Society Of Anesthiologists (ASA) I/II patients.
* BMI \<35
Exclusion Criteria
* ASA III/IV
* BMI \>35
* Chronic opioid use or abuse
* Pregnancy or breastfeeding
18 Years
75 Years
ALL
Yes
Sponsors
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Aswan University Hospital
OTHER
Responsible Party
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Sara Abd El Dayem Mohamed Abed
Resident of anesthesia, surgical intensive care & pain management
Principal Investigators
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Ayman M El-demirdash
Role: STUDY_CHAIR
Anesthesia, surgical intensive care and pain management - Aswan University Hospital
Hani M Raslan
Role: STUDY_DIRECTOR
Anesthesia, surgical intensive care and pain management - Aswan University Hospital
Zaher Z Zaher
Role: STUDY_DIRECTOR
Anesthesia, surgical intensive care and pain management - Aswan University Hospital
Central Contacts
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References
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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.
Alam 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.
Adeyinka A, Layer DA. Neuromuscular Blocking Agents. 2024 Jun 8. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK537168/
Other Identifiers
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944/7/24
Identifier Type: -
Identifier Source: org_study_id
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