Effects of Neostigmine-dose on Diaphragmatic Dynamics (DTF/DE/AChE)

Aswan University Hospital

Status and phase: Not yet enrolling; Phase 1

Conditions: Diaphragm Ultrasound

Treatments: Drug: full dose of Neostigmine; Drug: half dose of Neostigmine

Study type: Interventional

Funder types: Other

Identifiers

NCT06787638

944/7/24

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Adults scheduled for elective laparoscopic cholecystectomy.
• Age: < or = 18 years.
• Both genders.
• American Society Of Anesthiologists (ASA) I/II patients.
• BMI <35

Exclusion criteria

• Pre-existing diaphragmatic or respiratory disorders.
• ASA III/IV
• BMI >35
• Chronic opioid use or abuse
• Pregnancy or breastfeeding

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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50 participants in 2 patient groups

full dose of Neostigmine

Active Comparator group

Treatment:

Drug: full dose of Neostigmine

half dose of Neostigmine

Active Comparator group

Treatment:

Drug: half dose of Neostigmine