A Prospective Randomized Comparative Study to Evaluate the Use of Remifentanil as a Sole Agent or in Combination With Midazolam Versus Fentanyl/Midazolam During Sedation for Colonoscopy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- The Recovery Time
研究概览
简要总结
Colonoscopy is one of the most commonly performed outpatient procedure for diagnosis and treatment of lower gastrointestinal tract disorders. It has been largely accepted as an effective tool for colorectal cancer(CRC) screening, given its ability to detect and remove identified polyps. Increased colonoscopy utilization is associated with the observed decline in the incidence of CRC and its diagnosis at earlier stages. Diagnostic and therapeutic colonoscopy can successfully be performed using moderate sedation in the ambulatory setting. Techniques of sedation must guarantee the comfort and safety of patients, and at the same time allow a rapid turnover of patients.. An anaesthetic agent with rapid onset and offset of action, and convenient titration of anaesthetic/analgesic depth as well as rapid recovery to enable discharge from the endoscopy unit as soon as possible would be ideal as most such procedures are performed in the Non-Operating Room Anaesthesia(NORA) settings.
There is recent interest in the use of Remifentanil, in endoscopic units as it might have advantages over other drugs because of its profound analgesic effects, rapid onset and offset time and rapid titration to the individual patient's requirements and intermittent pain during colonoscopy.
The aim of this randomized study is to test the hypothesis that a colonoscopy of good quality in terms of pain relief, patient comfort and discharge times with less cardiorespiratory side effects can be performed using Remifentanil as a sole agent as compared with the standard midazolam/fentanyl protocol. The second group combining Remifentanil with Midazolam is taken to evaluate if there is any advantage of adding an anxiolytic amnesic drug as used in the standard Midazolam/Fentanyl Protocol.
详细描述
A Prospective Randomized Comparative Study to Evaluate the Use of Remifentanil as a Sole Agent or in Combination with Midazolam Versus Fentanyl/Midazolam during Sedation for Colonoscopy.
Background:
Audits of patient experiences and studies on quality improvement for colonoscopy have shown that increased sedation administration results in long-lasting improvement of colonoscopy quality indicators. However deep sedation in NORA ambulatory settings has been associated with increased sedation associated risks and raises costs for healthcare providers. Sedation may delay discharge of patients or cause discharge of patients with early cognitive impairment that contraindicate complex activities of daily living, The search is still on for an ideal drug that produces optimal operating conditions with minimum postoperative cognitive impairment.
Remifentanil is an ultrashort, very potent narcotic, which is eliminated by plasma and tissue esterases. There is recent interest in the use of Remifentanil in endoscopic units as it might have advantages over other drugs because of its profound analgesic effects, rapid onset and offset time and rapid titration to the individual patient's requirements and intermittent pain during colonoscopy. There are a few studies which suggest that the analgosedation(intense pain relief without loss of consciousness) achievable with remifentanil is a valid alternative to the present sedo-analgesia techniques used for colonoscopic sedation.
Ackcaboy ZN conducted a prospective randomized trial to test the hypothesis that continuous infusion of low dose remifentanil (0.05mcg/kg/min) continuous and bolus injection - in combination with 2 mg of midazolam, can provide effective analgesia, sedation, amnesia, patient comfort and stable recovery profile without respiratory depression when compared with Propofol infusion during colonoscopy.
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
- Single (Participant)
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
- •Patients between 18-75 years
- •ASA Grade I, II and controlled ASA III.
排除标准
- •Patient Refusal
- •Patients with psychiatric or Emotional Disorders
- •Previous adverse reaction to any of the drugs used
- •History of addiction to opiates/sedatives/alcohol
- •ASA Grade 3-4 patients with clinically significant or uncontrolled cardiovascular or respiratory disease.
- •Age <=18years
研究组 & 干预措施
Midazolam and Fentanyl
Midazolam and Fentanyl Two minutes before the colonoscopy procedure, a bolus of midazolam 0.03mg/Kg and 1.5microgram/Kg fentanyl will be given intravenously over 60 sec in group 1. 0.5 mg of midazolam intravenously can be given every two minutes till the patient is sufficiently sedated (sleeping but arousable on calling). The colonoscopy can start at this end point. Increments of 0.5mcg/Kg of fentanyl will be given if patient complains of pain, which can be repeated every 5 minutes if there is persistent pain
干预措施: Midazolam, Fentanyl (Drug)
Midazolam and Remifentanil
Midazolam and Remifentanil Target controlled infusion of Remifentanil to 3.0 ng/ml will be started 2 minutes before procedure. The patient will then be given same doses of midazolam in 0.5 mg increments till sedated sufficiently (sleeping but arousable on verbal command). During Colonoscopy the dose of Remifentanil could be increased by 0.5ng/ml if patient complained of pain upto 4.0ng/ml.
干预措施: Midazolam, Remifentanil (Drug)
Remifentanil
Remifentanil Group Patients will receive only Remifentanil in the same doses as given in group 2. During the procedure if the pain is excessive and persistent in spite of increasing the respective doses as prescribed in each group, or causing loss of cooperation of patient and interfering in the performance of procedure, the patients will be given sleep dose of Inj Propofol and further anaesthesia care as required will be provided for same.
干预措施: Remifentanil (Drug)
结局指标
主要结局
The Recovery Time
时间窗: 30 min
Every 5 minutes till a score of 10/10 achieved on Aldrete Score
propofol consumption
时间窗: 60 minutes
Number of patients in each group who had to receive propofol due to loss of cooperation
次要结局
- Endoscopist Satisfaction(60 min)
- Incidence of Patient's Recall.(6 hours)
- Patient satisfaction(6 hours)
- Side effects(6 hours)