Effect of Dexamethasone, Dexmedetomidine and Their Combination on Postoperative Gastrointestinal Function Measured by I-FEED Score After Elective Laparoscopic Cholecystectomy Surgery: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- The highest I-FEED score
研究概览
简要总结
The goal of this clinical trial is to learn the effect of Dexamethasone and Dexmedetomidine and Their Combination on Post op. GIT Function Measured by I-FFED Score Post Laparoscopic Cholecystectomy
What medical problems do participants have when taking Dexamethasone and Dexmedetomidine? Researchers will compare Dexamethasone and Dexmedetomidine and Their Combination to a placebo (a look-alike substance that contains no drug) to see the effect on Post op. GIT Function Measured by I-FFED Score Post Laparoscopic Cholecystectomy Participants will receive Dexamethasone 8 mg IV + Saline IV (total volume 10 ml) over 10 minutes administered after induction of anesthesia.
Participants will receive Dexmedetomidine 0.5 mcg /kg IV + Saline IV (total volume 10 ml) over 10 minutes administered after induction of anesthesia.
Participants will receive Dexamethasone 8 mg IV + Dexmedetomidine 0.5 mcg/kg IV+ Saline IV (total volume 10 ml) over 10 minutes administered after induction of anesthesia.
Participants will receive Saline IV (total volume 10 ml) over 10 minutes administered after induction of anesthesia
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •. Age 18-65 years.
- •American Society of Anesthesiologists (ASA) physical status I or II.
- •Scheduled for elective laparoscopic cholecystectomy surgery under general anesthesia.
- •Ability to provide written informed consent
排除标准
- •Known allergy or contraindication to any study drug (dexamethasone, dexmedetomidine, or placebo).
- •Pre-existing gastrointestinal motility disorders (e.g., gastroparesis, inflammatory bowel disease).
- •Chronic use of opioids, steroids, or antiemetics.
- •History of severe cardiac disease (e.g., high-grade AV block, severe bradycardia).
- •Uncontrolled diabetes mellitus (HbA1c > 8.0%).
- •Emergency surgery or conversion to open surgery.
- •Pregnancy or breastfeeding.
- •Morbid obesity (BMI >40).
- •Severe hepatic or renal dysfunction.
研究组 & 干预措施
Group P (Placebo)
干预措施: Placebo (Drug)
Group D (Dexamethasone)
干预措施: Dexamethasone (Drug)
Group X (Dexmedetomidine)
干预措施: Dexmedetomidine (Drug)
Group DX (Combination)
干预措施: Dexamethasone and dexmedetomidine (Drug)
结局指标
主要结局
The highest I-FEED score
时间窗: 24 -48 hours post operative
recorded daily from Postoperative Day (POD) 1 to POD 2. The I FEED score is calculated based on five components: Intake, Feeling nauseated, Emesis, Examination, and Duration of symptoms
次要结局
- Time (hours) to first flatus and first defecation(24-48 hours post operative)
- Time to tolerate oral intake.(24-48 hours postoperative)
- postoperative nausea and vomiting (PONV), Incidence and severity(24-48 hours)
- Total rescue opioid consumption(24-48 hours postoperative)
- incidence of POGD (defined as I-FEED score > 2)(24-48 hours postoperative)
- • Any adverse events related to study drugs(24-48 hours postoperative)
- • Length of hospital stay (days) from surgery to discharge(1 week post operative)
研究者
Taghreed Elshahat Sakr
lecturer of anesthesia and icu
Benha University