Estimation of Effective Dose 95 (ED95) of Intrathecal Isobaric 2-chloroprocaine (2-CP) Based on the Height (cm) of a Patient Undergoing Ambulatory Knee Arthroscopy : Dose-finding Study Based on the Continual Reassessment Method (CRM)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Success or failure of anesthesia
研究概览
简要总结
In ambulatory surgery, the choice of the local anesthetic used is essential. The ideal local anesthetic must allow a quick installation of the spinal block, a duration of the sensory block adapted to the surgery with a minimum of side effects. These side effects include bradycardia, hypotension and block failure during the intraoperative period; bladder retention, transient neurological disorders during the post-operative period. The achievement of kinetic objectives associated with a reduction in side effects is related to the choice of local anesthetic and the dose administered. However, there are interindividual pharmacokinetic variations that make it difficult to predict the effective dose and the unfortunate occurrence of side effects.
In this context, the height of the patient is a criterion involved in the level, the duration of the sensitive motor block and therefore the side effects
The local anesthetic of the amino ester family, isobaric 2-chloroprocaine (2-CP) has been successfully used for spinal anesthesia since several decades. With a short duration of action, it is preferred to other anesthetics for the short-term outpatient surgeries. However, the effective dose 95 (ED95) of intrathecal isobaric 2-CP is currently unknown.
The purpose of this prospective study is to determine the ED95 of the spinal 2-CP using the continuous re-evaluation method (Continual Reassessment Method) (CRM) based on patient's height
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •signed informed consent
- •scheduled outpatient knee arthroscopy
- •between 18 and 80 years old
- •American Society of Anesthesiologists physical status (ASA) < III
- •Height between 150 and 195 cm
排除标准
- •cardiac pathology (such as heart failure, aortic stenosis)
- •coagulation disorder (International Normalized Ratio (INR) > 1.3, platelets<80.000/mm3)
- •known allergy to local anaesthetics
- •central and peripheral neuropathies
- •patient's refusal
研究组 & 干预措施
Cohort 1 : Height 150-165 cm
Dose-finding study with 4 subjects per dose and a maximum of 40 patients by cohort. The cohort 1 includes patients whose the height is between 150 and 165 cm. To identify the dose to give for reaching the ED95 (effective dose for 95% subjects), isobaric 2-chloroprocaine will be administrated at the dose initial of 40 mg in the cohort 1 for the first 4 subjects. For the next subjects, the doses to administrate will vary 5 mg (0.5 ml) and will be determined by the Continual Reassessment Method (CRM) according to the observed responses in the previous subjects. Doses will be staggered from 25 to 50 mg for cohort 1.
干预措施: Isobaric 2-chloroprocaine (Drug)
Cohort 2 : Height 166-180 cm
Dose-finding study with 4 subjects per dose and a maximum of 40 patients by cohort. The cohort 2 includes patients whose the height is between 166 and 180 cm. To identify the dose to give for reaching the ED95 (effective dose for 95% subjects), isobaric 2-chloroprocaine will be administrated at the dose initial of 45 mg in the cohort 2 for the first 4 subjects. For the next subjects, the doses to administrate will vary 5 mg (0.5 ml) and will be determined by the Continual Reassessment Method (CRM) according to the observed responses in the previous subjects. Doses will be staggered from 30 to 55 mg for cohort 2.
干预措施: Isobaric 2-chloroprocaine (Drug)
Cohort 3 : Height 181-195 cm
Dose-finding study with 4 subjects per dose and a maximum of 40 patients by cohort. The cohort 3 includes patients whose the height is between 166 and 180 cm. To identify the dose to give for reaching the ED95 (effective dose for 95% subjects), isobaric 2-chloroprocaine will be administrated at the dose initial of 50 mg in the cohort 3 for the first 4 subjects. For the next subjects, the doses to administrate will vary 5 mg (0.5 ml) and will be determined by the Continual Reassessment Method (CRM) according to the observed responses in the previous subjects. Doses will be staggered from 35 to 60 mg for cohort 3.
干预措施: Isobaric 2-chloroprocaine (Drug)
结局指标
主要结局
Success or failure of anesthesia
时间窗: perioperative
The anesthesia will be considered as a success if there is an extension of the sensory block to the Th12 dermatome after inflation of the tourniquet, absence of pain during tourniquet inflation, incision and overall surgery. Or the anesthesia will be considered as a failure if there is an absence of extension of the sensory block at the Th12 dermatome, pain at the tourniquet inflation, at the incision, or during surgery.
次要结局
- Maximum level of sensory block assessed as loss of sensation to pinprick, cold(Until complete release of sensory block (up to 5 hours after surgery))
- Level of motor block assessed by the Bromage score(Until complete release of motor block (up to 5 hours after surgery))
- Side-effects (nausea, vomiting)(up to 5 hours after surgery)
- Pain as assessed by Visual Analog Scale(up to 24 hours after surgery)
- End time of sensory block(Until complete release of sensory block (up to 5 hours after surgery))
- Time to void(up to maximum 5 hours after surgery)
- Bladder volume before first micturition(up to maximum 5 hours after surgery)
- Time to eligibility for discharge defined by complete regression of sensory block(up to maximum 5 hours after surgery)