The Comparison of Two Different Techniques of Remifentanil Consumption During Implantable Vascular Access Device Procedures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 107
- 试验地点
- 4
- 主要终点
- The Numeric Pain Intensity Rating Scale (NPRS)
研究概览
简要总结
Our aim was to investigate whether remifentanil use in both infusion and bolus techniques could provide sufficient sedation and analgesia without serious adverse effects for central venous access device procedures under monitored anesthesia care.
详细描述
The insertion and removal of implantable venous access devices (port-a-cath type) requires moderate level of sedation and monitored anesthesia care to prevent pain and anxiety of patients during the procedure. According to the American Society of Anesthesiologist Physical Status Score, monitored anesthesia care is a planned procedure where a patient undergoes local anesthetic infiltration together with sedation and analgesia. Remifentanil is a potent synthetic opioid with novel pharmacokinetic properties, including very rapid onset and an ultra short duration of action, making it effective for pain relief in short procedures. Remifentanil can be administered as either one of the techniques of intravenous continuous infusion (CI) or intravenous bolus patient-controlled sedation analgesia (PCSA).In previous studies, the insertion or removal of venous access procedures required either local anesthesia or low doses of orally administered anxiolytic medication. The infusion of remifentanil may cause respiratory depression and analgesic efficacy and safety of administration of remifentanil infusion and/or bolus doses of remifentanil during the administration of one of the techniques of either CI or PCSA in short term procedures has not been well studied. The prospective trials that compare analgesic efficacy and adverse events related to intravenous remifentanil consumption in sedation and analgesia of short procedures are very limited.
This study aims to compare level of pain and sedation, total amount of remifentanil consumption, bolus doses of remifentanil, patient and surgeon satisfaction, hemodynamic data and adverse events of two different techniques of intravenous remifentanil use such as; intravenous continuous infusion (CI) or intravenous bolus patient-controlled sedation analgesia (PCSA) in patients under moderate level of sedation for vascular access procedures.
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
- Double (Participant, Outcomes Assessor)
盲法说明
In our study, random allocation sequence was performed using a computer programme for each patient to prevent bias. For concealed allocation, patients were randomly allocated into one group using a numbered, opaque and sealed envelope. A randomized block design is as follows: code A was given to the first group, and code B was given to the second group. The participant, data collector and data analyzer were blinded. This study was a single-blinded controlled study because the sedation and analgesia were administered by anesthesiology residents who were unaware of the technique and the study protocol however, the protocol was known by the experienced anesthesiologist who was attending the case and collecting the data during the procedure. The preparation of remifentanil solutions and installation of the infusion devices were done by an anesthesiologist who was blinded for the study groups.
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •30-80 years old,
- •American Society of Anesthesiologists Physical Status I to III,
- •Referred for an venous access device implantation or removal procedure.
排除标准
- •morbid obesity (body mass index > 40),
- •severe asthma, chronic obstructive lung disease, diabetes mellitus, hepatorenal disease,
- •a history of opioid allergy,
- •long-term opioid use or chronic pain,
- •ASA PS ≥ 4,
- •presence of epilepsy,
- •acute cerebrovascular event,
- •presence of hemodynamical instability such as peripheral oxygen saturation < 90%, systolic blood pressure < 60 mmHg and heart rate ≤ 40 bpm,
- •patients complaining about intense pain before the procedure.
结局指标
主要结局
The Numeric Pain Intensity Rating Scale (NPRS)
时间窗: After incision and during operative time every five minutes, through the operative time period up to two hours of time.
During NPRS pain evaluation, a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain comparison and this includes 0 as no pain and 10 as the worst pain imaginable. There is a comparison of pain scale scores as a decrease of pain relief in an amount of 30% from the pain at start between the two groups.
The faces pain rating scale
时间窗: After incision and during operative time every five minutes, through the operative time period up to two hours of time.
The scale shows a series of faces ranging from a happy face at 0, or "no hurt", to a crying face at 10, which represents "hurts like the worst pain imaginable".
Measurement of sedation and analgesia
时间窗: After incision and during operative time every five minutes, through the operative time period up to two hours of time.
The comparison of the use of Ramsay Sedation Scale for measurement of sedation and analgesia between the two groups.The Ramsay Sedation Scale involves 6 levels and these include; 1- Patient is anxious and agitated or restless, or both, 2- Patient is co-operative, oriented, and tranquil, 3-Patient responds to commands only, 4- Patient exhibits brisk response to light glabellar tap or loud auditory stimulus, 5-Patient exhibits a sluggish response to light glabellar tap or loud auditory stimulus, 6- Patient exhibits no response.
次要结局
- Total Remifentanil Consumption(At the end of operation, through the operative time period up to two hours of time.)
- Modified Aldrete Score(Through the recovery room time period before discharge up to one hour time.)
- Patient and surgeon satisfaction(The collection of questionnaire at the end of operation in recovery room after recovery from sedation in a total of ten minutes time.)
- Systolic blood pressure values during operation and in the recovery room.(The collection of systolic blood pressure in mmHg unit values every 15 minutes through the operative time period up to two hours of time and through the recovery room time period before discharge up to one hour time)
- Heart rate values during operation and in the recovery room.(Through the operative time period up to two hours of time and through the recovery room time period before discharge up to one hour time.)
- Duration of operation(At the end of operation, through the operative time period up to two hours of time.)
- Incidence of adverse events and side effects.(After operation in the recovery room through the recovery room time period before discharge up to one hour time and 24 hour after surgery.)
- Recovery time(Through the recovery room time period before discharge up to one hour time.)
- Diastolic blood pressure values during operation and in the recovery room.(The collection of diastolic blood pressure in mmHg unit values every 15 minutes through the operative time period up to two hours of time and through the recovery room time period before discharge up to one hour time)
- Pulse oximetry values during operation and in the recovery room.(hrough the operative time period up to two hours of time and through the recovery room time period before discharge up to one hour time)
- Hospital Stay(Through the duration of stay in hospital before discharge up to seventy two hours time.)
研究者
Ayse Baysal
The comparison of patient-controlled sedation method and anesthesiologist-controlled sedation method in port interventions
Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital