Diaphragmatic Dynamics in Laparoscopic Cholecystectomy: Comparing Neuromuscular Blocker Reversal Strategies-A Randomized Trial
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 主要终点
- Diaphragmatic Dynamics
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults scheduled for elective laparoscopic cholecystectomy.
- •Age: < or = 18 years.
- •Both genders.
- •American Society Of Anesthiologists (ASA) I/II patients.
排除标准
- •Pre-existing diaphragmatic or respiratory disorders.
- •ASA III/IV
- •Chronic opioid use or abuse
- •Pregnancy or breastfeeding
研究组 & 干预措施
full dose of Neostigmine
干预措施: full dose of Neostigmine (Drug)
half dose of Neostigmine
干预措施: half dose of Neostigmine (Drug)
结局指标
主要结局
Diaphragmatic Dynamics
时间窗: 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.
次要结局
未报告次要终点
研究者
Sara Abd El Dayem Mohamed Abed
Resident of anesthesia, surgical intensive care & pain management
Aswan University Hospital