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临床试验/CTRI/2023/01/049345
CTRI/2023/01/049345尚未招募不适用

COMPARISON OF HEMODYNAMIC PARAMETERS AND QUALITY OF ANAESTHESIA BETWEEN LEVOBUPIVACAINE (0.5% HYPERBARIC) AND BUPIVACAINE (0.5% HYPERBARIC) DURING SPINAL ANAESTHESIA IN ELDERLY PATIENTS (AGE 60 to 90 YRS) UNDERGOING UROLOGICAL SURGERIES.

PALLAVI SAXENA1 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2023年1月2日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
74
试验地点
1
主要终点
This study will help us to determine whether there is any significant difference between the hemodynamic parameters changes in elderly patients (age 60 to 90 yrs) undergoing urological surgeries between levobupivacaine (0.5%hyperbaric)and bupivacaine(0.5%hyperbaric) and compare the onset and duration of sensory action and motor action between them.

研究概览

简要总结

Spinal anesthesia has been a popular anesthesia technique for short urological surgeries.. Hy­perbaric racemic bupivacaine is commonly used for spinal an­esthesia due to its long duration of action and combined motor and sensory blockade. However, the use of hyperbaric racemic bupivacaine in spinal anesthesia has some drawbacks. It has a high propensity to cause hypotension and bradycardia follow­ing intrathecal injection, and there is potential for catastrophic cardiac toxicity due to the high affinity of bupivacaine to cardiac myocytes. Racemic bupivacaine is an equimolar mixture of dextro and levobupivacaine. Levobupivacaine has a lower affinity for car­diac sodium channels and greater plasma protein binding affin­ity compared with the dextro isomer; thus, reducing the risk of cardio-toxicity [3–5].  Levobupivacaine also results in earlier motor recovery compared with racemic bupivacaine [8,9]. These advantages make levobupivacaine an attractive alternative to racemic bupivacaine for spinal anesthesia.

Urological surgeries are performed under regional anaesthesia with subarachnoid blockade on a wide variety of patients ranging from the young, physically fit to the elderly with multiple comorbidities.Most of the patients presenting for urological surgeries belong to the geriatric population having a coexisting cardiac,pulmonary condition,or some other comorbidities.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
60.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • •Age 60 to 90yrs •height 145–180 cm •weight 50–100 kg •Both genders- male and female •ASA grade I and ASA grade II •Undergoing elective urological surgery of maximum 2 hrs of duration under spinal anaesthesia.

排除标准

  • 1.Age <60 yrs, > 90 yrs 2.Height<145cm, > 180 cm 3.Weight <50kgs, > 100 kg 4.ASA grade III and ASA grade IV 5.Patients with hepatic, cardiac, pulmonary, neuropsychiatric, renal or thyroid disease 6.Hypersensitivity to Bupivacaine or levobupivacaine.
  • 7.Any contraindication to spinal anaesthesia ( local infection, spinal deformity, coagulopathy).

结局指标

主要结局

This study will help us to determine whether there is any significant difference between the hemodynamic parameters changes in elderly patients (age 60 to 90 yrs) undergoing urological surgeries between levobupivacaine (0.5%hyperbaric)and bupivacaine(0.5%hyperbaric) and compare the onset and duration of sensory action and motor action between them.

时间窗: 3MINS | 5MINS | 10MINS | 15MINS | 30MINS | 45MINS | 60MINS | 90MINS | 120MINS

次要结局

  • hemodynamic parameters (Pulse rate & Blood pressure). 2. quality of anesthesia (onset and duration of sensory and motor blockade),(3.adverse effects of levobupivacaine (0.5%hyperbaric) and bupivacaine (0.5%hyperbaric). 4.post operative cognitive status.)

研究者

发起方
PALLAVI SAXENA
申办方类型
Other [self]

研究点 (1)

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