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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:
Participants will:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| full dose of Neostigmine | Active Comparator |
| |
| half dose of Neostigmine | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| full dose of Neostigmine | Drug | • 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | preoperatively and at zero, 10 minutes and 30 minutes postoperatively |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sara A Mohamed | Contact | +201153006436 | sara1704387@med.aswu.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Ayman M El-demirdash | Anesthesia, surgical intensive care and pain management - Aswan University Hospital | Study Chair |
| Hani M Raslan | Anesthesia, surgical intensive care and pain management - Aswan University Hospital |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11226114 | Background | 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. | |
| 35081706 | Background | 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. |
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| half dose of Neostigmine | Drug | • 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. |
|
| Zaher Z Zaher | Anesthesia, surgical intensive care and pain management - Aswan University Hospital | Study Director |
| 30725853 | Background | Adeyinka 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/ |