Influence of Spinal or Intravenous Dexmedetomidine on Spinal Anesthesia With Chloroprocaine and Bladder Function in Day-case Surgery. A Double Blind Randomized Study.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- sensory block regression L2 dermatome (minutes) (Time from injection until First time registration of loss of cold sensation)
研究概览
简要总结
The primary objective of this double blind randomized study is to determine the effect of dexmedetomidine on onset and duration of the sensory and motor block and on the influence on bladder function after spinal anesthesia with chloroprocaine. Our primary hypothesis is that sensory block will significantly be prolonged by dexmedetomidine administered by both the spinal and the intravenous route. The investigators do not expect a significant difference in motor block duration between intravenous or spinal administration. Secondary outcomes are micturition problems, duration of analgesia and the occurrence of side effects such as sedation and hypotension.
详细描述
The study is designed as a multicenter study and randomization and inclusion of patients will be performed in three hospitals. Each hospital has its own randomisation sequence and coordinating investigator who will be responsible for appointing blinded and unblinded participators in the study.
Patients scheduled for spinal anesthesia in ambulatory surgery will be randomized by sealed envelopes (computer generated sequence) into one of the following three study groups:
spinal chloroprocaine 40 mg with spinal dexmedetomidine (5mcg) spinal chloroprocaine 40 mg with intravenous dexmedetomidine ( 0.5 mcg/kg) spinal chloroprocaine 40 mg alone (control group)
All patients will receive the same amount of spinal solution, containing chloroprocaine 1% (4 ml) with dexmedetomidine (0.5 ml, 1 mcg/ml) or NaCl ( sodiumchloride) 0,9% (0.5 ml ) ( and 50 ml intravenous Nacl 0.9, containing dexmedetomidine (0.5 mcg/kg) or not depending on the study group. All solutions are prepared by an independent anesthesiologist and labelled as Intravenous study medication and spinal study medication. Spinal anesthesia and data registration will be done by a blinded anesthesist and/or study nurse on a data sheet designed for the study.
Spinal anesthesia is performed in the lateral decubitus at L3-L4 vertebral interspace and standard monitoring for this procedure is applied. Insufficient analgesia will be treated with sufentanil increments. Hypotension and bradycardia will be treated with ephedrine and atropine. Patients will be discharged when the block is regressed, there is no sedation or nausea and nrs scores of pain are below 4. Patients will be contacted by telephone after one week to evaluate any postoperative complaints.Micturition will receive a score based on bladder volumes measured by bladder scanning and subjective complaints . This score system was used in two of our former studies (1,2)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •ASA (American Society of Anesthesiologists) class 1 & 2,
- •undergoing day-case knee arthroscopy
排除标准
- •micturition problems,
- •neurological history or
- •previous lower abdominal surgery with an abnormal micturition
研究组 & 干预措施
C chloro + IV dexdor
Spinal chloroprocaine 40 mg IV dexmedetomidine 0.5 mcg/kg
干预措施: spinal chloroprocaine 40 mg (Other)
A chloro
spinal chloroprocaine 40 mg
干预措施: spinal chloroprocaine 40 mg (Other)
B chloro+ spin dexdor
Spinal chloroprocaine 40 mg spinal dexmedetomidine 0.5 mcg
干预措施: spinal dexmedetomidine 0.5 mcg (Drug)
B chloro+ spin dexdor
Spinal chloroprocaine 40 mg spinal dexmedetomidine 0.5 mcg
干预措施: spinal chloroprocaine 40 mg (Other)
C chloro + IV dexdor
Spinal chloroprocaine 40 mg IV dexmedetomidine 0.5 mcg/kg
干预措施: IV dexmedetomidine 0.5 mcg/kg (Drug)
结局指标
主要结局
sensory block regression L2 dermatome (minutes) (Time from injection until First time registration of loss of cold sensation)
时间窗: up to 360 minutes
Time from injection until First time registration of loss of cold sensation at the L2 dermatome during block regression. Loss of cold sensation will be regularly assessed from spinal injection until total regression of the sensory block
Motor block regression (minutes) (time from injection until achievement of active knee movement)
时间窗: up to 240 minutes
time from injection until achievement of active knee movement during block regression. Motor block will be assessed at regular intervals from spinal injection untill total regression of the motor block
次要结局
- time to micturition ( minutes)(up to 240 minutes)
- blood pressure drop(up to 240 minutes)
- discharge time (minutes)(up to 240 minutes)
研究者
Dr M. B. Breebaart
dr
University Hospital, Antwerp