Comparison of Dexmetomidine's Efficacy as an Adjuvant to Intrathecal Levobupivacaine and Intravenous Administration Additionally to Spinal Anaesthesia, In Total Knee Arthroplasty
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Onset and duration of sensory block using the ' pin-prick ' method,in total knee athroplasty, using DEX as an adjuvant to intrathecal Levobuvicaine and iv administration additionally to spinal anesthesia with Levobuvicaine
研究概览
简要总结
The present study is designed to evaluate and compare the efficacy of intrathecal dexmedetomidine (DEX) as an adjuvant to Levobupivacaine in spinal anaesthesia and DEX's intravenous administration, without loading dose, additionally to spinal anaesthesia, in patients undergoing total knee arthroplasty.
详细描述
Introduction
Various adjuvants like morphine, fentanyl, clonidine, ketamine are being used since long for improvement of intraoperative anaesthesia and postoperative analgesia following spinal anaesthesia. On the other hand, such adjuvants have their associated adverse effects. As a result, search for an effective adjuvant is still going on. Dexmedetomidine (DEX), a selective α2-adrenoceptor agonist, has analgesic and sedative effects and nowadays, is being studied for its adjuvant action in subarachnoid anaesthesia.
As far as DEX is concerned, it has been reported that it can be administered intravenously in additional to spinal anaesthesia, in order to promote sensory and motor blockade duration and postoperative analgesia, because of its synergistic action with local anaesthetics.
DEX is a highly selective alpha 2 adrenergic receptor agonist with a higher α2/α1 selectivity ratio of 1620:1 than clonidine (200:1). It was first introduced to clinical as a sedative in intensive care unit. Alpha-2 adrenergic receptor agonists have been tried by many clinicians due to their sedative, anxiolytic, hypnotic, analgesic, perioperative sympatholytic and stable haemodynamic properties. DEX, specifically, has all these properties, without causing respiratory depression. Currently its adjuvant action in spinal anaesthesia and its intravenous administration, additionally to subarachnoid anaesthesia, is being explored.
Aim The present study is designed to evaluate and compare the efficacy of intrathecal DEX as an adjuvant to Levobupivacaine in spinal anaesthesia and DEX's intravenous administration, without loading dose, additionally to spinal anaesthesia, in patients undergoing total knee arthroplasty.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients selected for total knee arthroplasty of approximately one and half hour (90 min) duration under spinal anaesthesia.
- •Patients who belong to American Society of Anaesthesiologists (ASA) physical status grade I and II
排除标准
- •Patients with coagulation and neurological disorders
- •Patients allergic to DEX
- •Patients showing unwillingness for spinal anaesthesia
研究组 & 干预措施
Levobupivacaine intrathecally
3 ml Levobupivacaine 0,5% (15mg) given intrathecally once for anesthesia in total knee arthroplasty
干预措施: Levobupivacaine (Drug)
Levobupivacaine intrathecally
3 ml Levobupivacaine 0,5% (15mg) given intrathecally once for anesthesia in total knee arthroplasty
干预措施: Normal Saline intrathecally (Drug)
Dexmetomidine intrathecally
5 μgr Dexmetomidine given intrathecally once for anesthesia in total knee arthroplasty
干预措施: Levobupivacaine (Drug)
Dexmetomidine intrathecally
5 μgr Dexmetomidine given intrathecally once for anesthesia in total knee arthroplasty
干预措施: Normal Saline added intrathecally (Drug)
Dexmetomidine intrathecally
5 μgr Dexmetomidine given intrathecally once for anesthesia in total knee arthroplasty
干预措施: Dexmetomidine intrathecally (Drug)
Dexmetomidine intravenously
Continuous infusion of dexdemetomidine at a rate of 0.25 μg/kg/h given intravenously starting 10 min before spinal anesthesia in total knee arthroplasty
干预措施: Levobupivacaine (Drug)
Dexmetomidine intravenously
Continuous infusion of dexdemetomidine at a rate of 0.25 μg/kg/h given intravenously starting 10 min before spinal anesthesia in total knee arthroplasty
干预措施: Dexmetomidine intravenously (Drug)
Dexmetomidine intravenously
Continuous infusion of dexdemetomidine at a rate of 0.25 μg/kg/h given intravenously starting 10 min before spinal anesthesia in total knee arthroplasty
干预措施: Ringer's Lactate solution intravenously (Drug)
Normal Saline intrathecally
0,5 ml Normal Saline given intrathecally given once for spinal anesthesia in total knee arthroplasty
干预措施: Levobupivacaine (Drug)
Normal Saline intrathecally
0,5 ml Normal Saline given intrathecally given once for spinal anesthesia in total knee arthroplasty
干预措施: Normal Saline added intrathecally (Drug)
Normal Saline intrathecally
0,5 ml Normal Saline given intrathecally given once for spinal anesthesia in total knee arthroplasty
干预措施: Dexmetomidine intrathecally (Drug)
Normal Saline added intrathecally
Normal Saline added intrathecally up to 0,5 ml given intrathecally for spinal anesthesia in total knee arthroplasty
干预措施: Levobupivacaine (Drug)
Normal Saline added intrathecally
Normal Saline added intrathecally up to 0,5 ml given intrathecally for spinal anesthesia in total knee arthroplasty
干预措施: Normal Saline intrathecally (Drug)
Normal Saline added intrathecally
Normal Saline added intrathecally up to 0,5 ml given intrathecally for spinal anesthesia in total knee arthroplasty
干预措施: Dexmetomidine intrathecally (Drug)
Ringer's Lactate solution intravenously
Continuous infusion of Ringer's Lactate solution given intravenously for total knee arthroplasty will start 10 minutes before spinal anesthesia to the end of the operation
干预措施: Levobupivacaine (Drug)
Ringer's Lactate solution intravenously
Continuous infusion of Ringer's Lactate solution given intravenously for total knee arthroplasty will start 10 minutes before spinal anesthesia to the end of the operation
干预措施: Dexmetomidine intravenously (Drug)
Ringer's Lactate solution intravenously
Continuous infusion of Ringer's Lactate solution given intravenously for total knee arthroplasty will start 10 minutes before spinal anesthesia to the end of the operation
干预措施: Ringer's Lactate solution intravenously (Drug)
结局指标
主要结局
Onset and duration of sensory block using the ' pin-prick ' method,in total knee athroplasty, using DEX as an adjuvant to intrathecal Levobuvicaine and iv administration additionally to spinal anesthesia with Levobuvicaine
时间窗: The time of onset will be taken from the time of injection of drug intrathecally to loss of pinprick sensation to T12 within 30 min. Duration of sensory blockade will be measured as time from onset to time of return of piniprick sensation to S1 level.
By using a hypodermic needle at 2 min interval, we will assess the 'pin-prick' sensation from T12 to S1 The onset of sensory block will be tested by 'pin-prick method' using a hypodermic needle at 2 minutes interval. The time of onset will be taken from the time of injection of drug into subarachnoid space to loss of pinprick sensation to T12 level. We study 90 patients(ASAI-II) devided in 3 groups and we measure the highest level of sensory block, time for two dermatomal segments regression of sensory level, duration of sensory blockade taken as time from onset to time of return of pinprick sensation to S1 (heel) dermatomal area will be noted.
Onset and duration of motor block using the Modified Bromage Scale, in total knee athroplasty, using DEX as an adjuvant to intrathecal Levobuvicaine and iv administration additionally to spinal anesthesia with Levobuvicaine
时间窗: Onset time will be taken from the time of injection of drug intrathecally to the patient's inability to lift the extended leg within 30 min. The duration will be taken from time of injection of drug to the patient's ability to lift the extended leg.
By using the Modified Bromage Scale we will assess the onset and duration of motor block. Grade 0 : Full flexion of knees and feet. Grade 1: Just able to flex knees, full flexion of feet. Grade 2: Unable to flex knees, but some flexion of feet possible. Grade 3; Unable to move legs or feet.
Duration of post-operative analgesia using the Visual Analogue Scale (VAS), in total knee arthroplasty, using DEX as an adjuvant to intrathecal Levobuvicaine and iv administration additionally to spinal anesthesia with Levobuvicaine
时间窗: We will record the post-operative analgesia using the Visual Analogue Scale (VAS) at the end of the surgery and 3, 6, 12,24 hours after the end of the surgeryn and at the end of the surgery. an interval of 3, 6 ,and 12 h after surgery
VAS is a scale from 0 to 10, with 0 indicating 'no pain' and 10 indicating the most severe pain, that somebody has experienced. Rescue analgesics will be given to the patients when VAS\>3, which will be the cut-off point of our study.
次要结局
- Hemodynamic stability of DEX, used as an adjuvant to intrathecal Levobupivacaine and intravenous administration additionally to spinal anesthesia, in total knee arthroplasy(HR will be recorded will be recorded at the time of the spinal injection, 10, 20, 30,45, 60 min after spinal injection and at the end of the surgery.)
- Adverse effects of DEX, used as an adjuvant to intrathecal Levobupivacaine and intravenous administration additionally to spinal anaesthesia with Levobupivacaine, in total knee arthroplasy(Adverse effects will be recorded will be recorded at the time of the spinal injection, 15, 30, 60 min after spinal injection, at the end of the surgery and 3, 6, 12, 24 hours after the end of the surgery)
- Sedation will be assessed with the Ramsay Sedation Scale, in total knee arthroplasty, by using DEX as an adjuvant to intrathecal Levobupivacaine and intravenous administration additionally to spinal anesthesia with Levobuvicaine(Sedation scores will be assessed will be recorded at the time of the spinal injection, 10, 20, 30,45, 60 min after spinal injection, at the end of the surgery and 30 minutes after the end of the surgery)
研究者
Ioanna Diagoupi
Intern doctor in anaesthesiology
KAT General Hospital