The Prolonged Effects of Spinal Dexmedetomidine Versus Intravenous Dexmedetomidine on Spinal Anesthesia With Isobaric Bupivacaine: A Comparative Study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Regression time of Bromage score from 3 to 0
研究概览
简要总结
This prospective, double-blinded, randomized clinical trial aims to examine the effects of combining isobaric bupivacaine with dexmedetomidine administered intrathecally (IT), compared to the combination of isobaric bupivacaine administered intrathecally and dexmedetomidine administered intravenously (IV), on spinal anesthesia prolongation time in minutes, time of regression from Bromage score 3 to 0.
详细描述
Dexmedetomidine, an α2-adrenergic agonist, is commonly used in anesthetic practice for various applications, including premedication, as an adjunct to general anesthesia, sole anesthetic agent, and sedation in intensive care settings. Its effects include enhancing the efficacy of other anesthetic drugs, inducing perioperative sympatholysis, and lowering blood pressure by stimulating central α2 and imidazoline receptors.
Spinal anesthesia is a type of regional anesthesia that involves administering a local anesthetic directly into the cerebrospinal fluid surrounding the spinal cord and nerve roots. It is primarily used for procedures below the umbilicus, such as orthopedic surgeries involving joints and bones.
The 0.5% isobaric formulation of bupivacaine is characterized by a slower onset compared to hyperbaric formulations but provides a longer duration of both sensory and motor blockade. Achieving successful spinal anesthesia (SA) depends on selecting the appropriate dose of isobaric bupivacaine. Administering an excessive dose can lead to high spinal anesthesia, while an insufficient dose may result in inadequate cephalad spread.
A retrospective observational study involving 1,079 adult patients who received spinal anesthesia with 0.5% isobaric bupivacaine between 2018 and 2021 investigated the relationship between the bupivacaine dose and block height. The study concluded that for patients younger than 60 years, doses of 15-17 mg (3.0-3.4 mL) were optimal, while doses of 10.5-16 mg (2.1-3.2 mL) were suitable for patients aged 60 years or older. These doses achieved a T5-T10
Over the years, various agents have been combined with local anesthetics (LA) to extend the duration of action in both spinal anesthesia via intrathecal (IT) administration and peripheral nerve blocks (PNB), achieving varying levels of success. Dexmedetomidine, a highly selective α2-adrenergic receptor agonist, offers several advantages as an adjuvant. These include its sedative and analgesic effects (acting at both spinal and supraspinal levels), anti-anxiety properties, inhibition of sympathetic activity, mild respiratory depression, and hemodynamic stability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
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
- 是
入选标准
- •Male and female patients in adult age group more than 18 years old
- •ASA classification I, II, and III.
- •Orthopedic surgery, including total hip replacement (THR) and total knee replacement (TKR).
- •No history of Obstructive sleep apnea
排除标准
- •Patient below 18 years old of both genders.
- •ASA classification of IV and more.
- •Patients with a height of less than 150 cm.
- •Patients on alpha-two antagonist ACE inhibitors and CCB.
- •Patient received intrathecal morphine, intravascular dexamethasone, or Midazolam
- •Patient who can't tolerate fluid challenge. Example: ESRD, HF...etc.
- •Any contraindication for neuraxial procedure. Examples: coagulopathy, severe AS, sepsis...etc.
- •Psychiatric patients.
研究组 & 干预措施
Dexmedetomidine HCL IT
Group B: RECEIVING IT "Dexmedetomidine HCL," "Demexa®," Through IT, receiving plain isobaric "Bupivacaine 0.5%", "Bucaine®," (2.4 ml) +3mcg of "Dexmedetomidine HCL, (0.15 ml), total volume = 2.4 ml.
Through IV, 15 ml of normal saline ( placebo) will be received over 30 mins.
干预措施: Interventional group#1 (Drug)
Dexmedetomidine HCL IV
Group C: RECEIVING IV "Dexmedetomidine HCL," "Demexa®,"
Through IT, receiving plain isobaric "Bupivacaine 0.5%", "Bucaine®," (2.4 ml) + Placebo of normal saline (0.15 ml), total volume = 2.4 ml.
Through IV, 0.5 mcg/kg of "Dexmedetomidine HCL" is prepared in a concentration of 2 mcg/ml ( maximum of 15 ml, 30 mcg) over 30 mins.
干预措施: Interventional group#2 (Drug)
结局指标
主要结局
Regression time of Bromage score from 3 to 0
时间窗: Patients' recruitment and participation in the study will be over 3-4 month, as the load of lower limb surgery at KAMC is high. Subjects' participation will be throughout the surgery time and 45 mins later in PACU if there was not a reason for delay.
This double-blind study will include 75 participants divided equally into three groups: A, B, and C. The IT medication injection / IV infusion start time is considered time zero. The Bromage score will be assessed at the motor block's onset, representing a Bromage score of 3, recorded in minutes. The record of the time to reach Bromage 3 represents the spinal anesthesia's onset time. The Bromage scale is a clinical scale used to determine motor block during regional anesthesia. It evaluates lower limb movement, grade 0, no motor block, to grade 3, complete motor block. Bromage 0; the patient can move hip, knee, and ankle. No motor block Bromage 1: the patient cannot move the hip but can move the knee and ankle. Partial block Bromage 2: the patient cannot move the hip and knee but can move the ankle. partial block Bromage 3: the patient cannot move the hip, knee, and ankle. Complete motor block A Bronage score regression to 0 during a PACU stay will represent a spinal anesthesia offset
次要结局
- Hypotension, bradycardia and desaturation with dermatome coverage <T4 or >T4, checked by Ice test.(Patients' recruitment and participation in the study will be over 3-4 month, as the load of lower limb surgery at KAMC is high. Subjects' participation will be throughout the surgery time and 45 mins later in PACU if there was not a reason for delay.)
- Sedation score using Ramsay sedation score, aiming for score 2; calm and oriented.(Patients' recruitment and participation in the study will be over 3-4 month, as the load of lower limb surgery at KAMC is high. Subjects' participation will be throughout the surgery time and 45 mins later in PACU if there was not a reason for delay.)
研究者
Hebah Musalem
Anesthesia Assistant consultant
King Abdulaziz Medical City