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临床试验/CTRI/2025/09/094069
CTRI/2025/09/094069尚未招募2/3 期

COMPARISON OF EFFECTS OF DEXMEDETOMIDINE ADDED TO LEVOBUPIVACAINE VERSUS LEVOBUPIVACAINE ALONE INFILTRATION SCALP BLOCK FOR ATTENUATION OF THE HAEMODYNAMIC RESPONSE TO SKULL PIN PLACEMENT IN NEUROSURGICAL PROCEDURES A DOUBLE BLIND RANDOMISED CLINICAL TRIAL

J L N Medical college1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年9月15日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
duration of analgesia

研究概览

简要总结

Skull pin placement during brain surgery often causes significant pain and stress responses, such as increases in heart rate and blood pressure. Scalp nerve blocks with local anesthetics are commonly used to reduce this response. Levobupivacaine is a safe and effective local anesthetic, and dexmedetomidine is an adjuvant that may enhance its effect by providing better pain relief and reducing the stress response. This study aims to compare the effectiveness of levobupivacaine alone versus levobupivacaine combined with dexmedetomidine for scalp nerve blocks. The main focus is on how well each technique reduces the body’s stress response during skull pin insertion. Results may help improve patient comfort and stability during neurosurgery.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • all adult patients of either 18 -65 years of age belonging to American Society of Anaesthesiologist physical status (ASA PS) grading 1 and 2 schedule forelective craniotomoy requiring placement of Mayfieldskull pins under general anaesthesia.

排除标准

  • patient refusal patient with known allergies to study medication patient with uncontrolled hypertension perioperative bradycardia (heart and renal disease) patient on chronic opioid or alpha2-adrenergic agonist/antagonist therapy pregnant or lactating.

结局指标

主要结局

duration of analgesia

时间窗: assessment of visual analogue score for pain in post operative period at immediately after shifting post operative unit after 1hr 2hr 3hr 4hr 6hr 8hr 10hr

次要结局

  • onset & duration of sensory block onset duration of motor block(assessment of sensory block using pin prick sensation assessed)

研究者

发起方
J L N Medical college
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Maina Singh

Jawahar Lal Nehru Medical College Ajmer Rajasthan

研究点 (1)

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