2024-516325-31-01招募中4 期
Placebo-controlled double-blind trial of the analgesic effect and safety of clonidine in patients after major abdominal surgery
Esbjerg Og Grindsted Sygehus1 个研究点 分布在 1 个国家目标入组 182 人开始时间: 2024年12月17日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 182
- 试验地点
- 1
- 主要终点
- Use of morphine 24 hours post-operatively
研究概览
简要总结
The relationship between a single iv. bolus dose of clonidine administered postoperatively to patients undergoing colectomy and postoperative acute pain.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Planned colectomy due to cancer. • Age over 18 years. • Able to read and understand Danish. • Willingness and able to comply with scheduled visit, treatment plan, laboratory tests and other trial procedures.
排除标准
- •Sick sinus syndrome. • Second- or third-degree atrioventricular block. • Known hypersensitivity, intolerance or allergy towards clonidine or morphine. • Clinically relevant side effects or symptoms of allergy, judged by the investigator. • Pregnancy (positive urine HCG)/ lactating. • Participants with any clinical abnormalities that, in the opinion of the investigator, may increase the risk associated with trial participation or may interfere with the interpretation of the trial results • Participation in other clinical studies less than six month prior to inclusion. • Hypotension (persistent systolic blood pressure below 100 mmHg). • Bradycardia (< 50 beats/minute). • Known significant decreased kidney function, or an eGFR below 30 ml/min. • Use of a α-agonist drug. (Clonidine, Dexmedetomidine, Tizanidine). • Use of a α-adrenoceptor blocking drug. (Phentolamine, Tolazoline, Phenoxybenzamine, Prazosin, Terazosin, Doxazosin, Alfuzosin, Bunazosin, Tamsulosin, Silodosin, Yohimbine, Idazoxan, Ergot alkaloids).
研究组 & 干预措施
-
Placebo Comparator
Participants receiving -
干预措施: - (Drug)
结局指标
主要结局
Use of morphine 24 hours post-operatively
Use of morphine 24 hours post-operatively
次要结局
- VAS/NRS (pain scores), Qestionnaires, QST (Quantitative Sensory Testing), ANS (BP, ECG, HR, Sat, Tp, Pupil reaction), Certain genetic profile (CYP2D6, OPRM and COMT sequenced. SNPs of ABCB1 and rs2952768/CREB1 and ncRNA), Blood samples (concentrations of clonidine, morphine, morphine-3-glucoronide, morphine-6-glucoronide), Demographics, physical, medical, laboratory data, Physical examination.
研究者
Clinical trial information desk c/o department of Anesthesiology
Scientific
Esbjerg Og Grindsted Sygehus
研究点 (1)
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