NCT07550751已完成4 期
Optimal Melatonin Dosage for Effective Sedation, Hemodynamic Stability and Pain Control in Functional Endoscopic Sinus Surgery (FESS)
Aswan University Hospital1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2024年8月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- preoperative sedation using ramsay sedation scale
研究概览
简要总结
To determine the optimal dosage of Melatonin for preoperative sedation in patients undergoing FESS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Care Provider)
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
- 是
入选标准
- •- ASA 1 ASA 2 patients scheduled for elective FESS under general anesthesia
排除标准
- •hypersensitivity or contraindication to the drug
- •Severe psychiatric disorders.
- •Regular use of sedatives or analgesics.
- •Pregnancy or breastfeeding
- •Significant systemic diseases such as severe cardiovascular, hepatic, or renal dysfunction.
研究组 & 干预措施
D
Other
Melatonin 10mg
干预措施: Melatonin (Drug)
A
Other
placebo
干预措施: Melatonin (Drug)
B
Other
Melatonin 3mg
干预措施: Melatonin (Drug)
C
Other
Melatonin 5mg
干预措施: Melatonin (Drug)
结局指标
主要结局
preoperative sedation using ramsay sedation scale
时间窗: just before intravenous anesthetic induction and one hour after recovery
assess of sedation pre-induction of anesthesia and one hour after recovery
次要结局
- perioperative anxiety using The six-item State-Trait Anxiety Inventory (STAI-6) scale(Baseline one hour before surgery, just before induction of anaesthesia and one hour after recovery)
- Measuring heart rate in beat/min(Baseline and perioperative)
- Measuring blood pressure (systolic, diastolic and mean arterial pressure) in mmHg(Baseline and perioperative)
- Measuring oxygen saturation (in percentage) using pulse oximeter(Baseline and perioperative)
- Postoperative pain assessment using Visual Analogue score of pain(1,2,4and6 hours postoperative)
研究者
Osaid Abdelshakour Elsayed Abdallah
anesthesia, surgical intensive care unit and pain management resident doctor.
Aswan University Hospital
研究点 (1)
Loading locations...
相似试验
尚未招募
不适用
to assess the effect of Melatonin in patients undergoing awake craniotomyCTRI/2024/09/074211All India Institute of Medical Sciences40
尚未招募
4 期
Oral melatonin and alprazolam for postoperative pain management in abdominal hysterectomy.CTRI/2025/09/095057Abhirami NP102
进行中（未招募）
不适用
Clinical and Radiographic Evaluation of Local Application of Melatonin on Postoperative Outcomes After Surgical Removal of Impacted Mandibular Third MolarNCT07374536Suez Canal University20
尚未招募
不适用
A Comparative study of effectiveness of two different drugs (alprazolam and melatonin) on the quality of sleep in patients posted for elective surgeryCTRI/2025/07/091965Dr Janet Jassica J160
尚未招募
Unknown
a clinical trial to study efficacy of two different doses of melatonin for anxiety alleviation in pre-operative patientsCTRI/2024/08/072706Dayanand Medical College and Hospital100