A Study to Assess Sedation Using Intranasal Dexmedetomidine in Upper Gastrointestinal Endoscopy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 50
- 主要终点
- Consumption of Rescue Patient Controlled Propofol
研究概览
简要总结
Upper gastrointestinal endoscopy, like many other diagnostic and therapeutic procedures, may be associated with discomfort. Although upper endoscopy is usually of shorter duration and better tolerated by patients, most trials investigating the influence of analgesia and sedation have been performed on patients undergoing this procedure. Some patients may tolerate colonoscopy without sedation, but various techniques are used to limit discomfort and pain. Selection and dosing of sedatives depends on the patient's emotional state, the intensity of pain during examination, foreseeable technical difficulties, the endoscopist's experience, the presence or absence of anesthesia personnel, and hospital-specific procedures.
Conscious sedation is a popular technique for colonoscopy and upper gastrointestinal endoscopy. The combination of an opioid and a benzodiazepine is known to provide good analgesic and sedative conditions during endoscopy. This combination of opioid and benzodiazepine, however, also increases the risk of respiratory depression. Therefore, pharmacologic agents which may provide adequate sedation without respiratory depression are of great interest to clinicians.
Dexmedetomidine is a highly selective α2-adrenoceptor agonist with sedative and analgesic effects. Compared with clonidine, it is more selective for the α 2 adrenoceptor and acts as a full agonist in most pharmacologic test models. Potentially desirable properties include decreased requirements for other anesthetics and analgesics, a diminished sympathetic response to stress and the potential for cardioprotective effects against myocardial ischemia. When compared with conventional sedatives such as opioids or benzodiazepines, its lack of respiration depression is a distinct advantage. Previous studies using dexmedetomidine for sedation has been promising with maintenance of respiratory function. Patients are readily arousable. With intravenous slow bolus administration, there is a minimal increase in blood pressure initially, followed by a slight decrease in blood pressure. Lower dose ranges, avoidance of rapid bolus injection, and a slow rate of administration tend to decrease these circulatory side effects. Many clinical studies have shown that it can be well and safely used intravenously, intramuscularly and transdermally. Although not an officially technique, there are also reports of intranasal administration resulting in fairly predictable onset in both adults and children.
详细描述
Aims:
This study aims to evaluate sedative effects using intranasal dexmedetomidine in upper gastrointestinal endoscopy. The investigators aim to evaluate the efficacy, side effects and acceptability of sedation using intranasal dexmedetomidine by patients and endoscopist for upper gastrointestinal endoscopy.
Methods:
Double blind randomized prospective study.
Sample size:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiology grade I-III
- •18-60 years old
- •Patients having upper endoscopy
排除标准
- •Clinical history or electrocardiographic evidence of heart block, ischaemic - heart disease, asthma, sleep apnoea syndrome
- •BMI > 35kg/m2
- •Impaired liver (preoperative serum albumin level less than 30g/L ) or renal function (creatinine >120umol/L)) or known renal or hepatic disease
- •Alcohol consumption in excess of 28 units per week
- •Pregnancy
- •Patient refusal
- •Known psychiatric illness
- •Chronic sedative use, and regular use of or known allergy to dexmedetomidine, propofol and opioids.
研究组 & 干预措施
Normal Saline
Normal saline was given intranasally
干预措施: Placebo (Drug)
Dexmedetomidine
1.5mcg dexmedetomidine was given intranasally before procedure
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
Consumption of Rescue Patient Controlled Propofol
时间窗: Up to 30 minutes during gastrointestinal endoscopy
Until the removal of the endoscopy from the patients
次要结局
- Side Effects of Intrananasal Dexmedetomidine(Up to 24 hours after Upper Endoscopy)
研究者
Dr. Chi-Wai Cheung
Clinical Associate Professor
The University of Hong Kong
