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临床试验/CTRI/2024/06/069439
CTRI/2024/06/069439尚未招募Phase 3 4

Discharge Time And Satisfaction Score Of Patients Undergoing Endoscopies Under Intravenous Remifentanil Sedation - A Prospective Observational Study

Regional cancer centre,Trivandrum1 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2024年7月8日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
74
试验地点
1
主要终点
1. To determine the time to discharge in patients undergoing endoscopies under remifentanil sedation.

研究概览

简要总结

Remifentanil an ultra-short acting opioid with an analgesic potency similar to that of fentanyl, has been introduced into the Indian market in November 2023. Remifentanil given as infusion might provide adequate analgesia and sedation with better patient satisfaction during endoscopic procedures. Hence this study is being proposed.

Research question:Does Intravenous Remifentanil infusion provide better patient satisfaction and adequate analgesia without prolonging time to discharge after endoscopic procedures?

Null hypothesis: Intravenous Remifentanil infusion will not reduce the discharge time or improve patient satisfaction during endoscopies.

Aim of the study is to evaluate the discharge time and patient satisfaction after Remifentanil infusion in patients undergoing endoscopies.

Based on previous literature, the sample size required will be 74 participants with power (1-β) 80% and level of significance(α) at 5%.

Method:

Routinely patients undergo endoscopies under iv midazolam sedation alone or in combination with iv fentanyl given as bolus doses as required. They are provided O2 via facemask and vitals (Heart rate, SpO2 and BP) are monitored during the procedure.

Study procedure:

Patients will be instructed to attend the endoscopy unit with two hours fasting for clear liquids and 6 hours for solid foods. A 20 gauge iv canula will be secured on arrival to the endoscopy room. Patients will be given iv Remifentanil infusion at a dose of 0.25 - 1 μgm/kg/minute along with 1 mg of iv Midazolam bolus dose. The procedure will start after one minute of starting the Remifentanil infusion. A baseline and intraprocedural Ramsay sedation score will be recorded as assessed by the attending anaesthesiologist. Intraprocedural HR, BP, ETCO2 and SpO2, total and supplemental dose of Remifentanil will be recorded. The Remifentanil infusion will be stopped on withdrawal of the endoscope. The time of discharge after sedation based on MPADSS will be assessed by the recovery nurse and entered into the proforma. Any adverse events (like nausea, vomiting) will also be entered into the proforma. Any bradycardia will be treated with atropine. Nausea/ vomiting if any will be treated with iv ondansetron 0.1mg/kg. Patient satisfaction will be assessed after the procedure using the VAS. The Surgeon’s satisfaction will also be assessed using VAS. The patient sedation score and time to recovery from Remifentanil will be compared with the existing data of midazolam/fentanyl sedation.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • Age 18 to 75 years Both males and females ASA 1 and 2.

排除标准

  • Age less than 18 and more than 75 years ASA 3 and above Allergic to any opioids.

结局指标

主要结局

1. To determine the time to discharge in patients undergoing endoscopies under remifentanil sedation.

时间窗: 1.Immediately after endoscopy | 2.10 minutes after procedure

2. To assess the patient satisfaction to remifentanil sedation using Visual Analogue Scale (VAS) after the procedure.

时间窗: 1.Immediately after endoscopy | 2.10 minutes after procedure

次要结局

  • 1.To evaluate sedation during endoscopies using Ramsay sedation score.(2. To determine the total and supplemental dose of Remifentanil, required for sedation.)

研究者

发起方
Regional cancer centre,Trivandrum
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Rajasree O

Regional Cancer Centre , Trivandrum

研究点 (1)

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