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临床试验/CTRI/2025/09/094413
CTRI/2025/09/094413尚未招募2/3 期

A COMPARATIVE STUDY BETWEEN ISOBARIC LEVOBUPIVACAINE WITH HYPERBARIC BUPIVACAINE IN UROLOGIC SURGERIES: A PROSPECTIVE RANDOMISED CONTROLLED TRIAL

SNEHA ANAND1 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2025年9月25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
74
试验地点
1
主要终点
To compare the onset, duration of sensory and motor blockade in

研究概览

简要总结

SPINAL ANESTHESIA PLAYS A PIVOTAL ROLE IN MODERN SURGICAL PRACTICE, OFFERING INTRAOPERATIVEANESTHESIA AND POSTOPERATIVE ANALGESIA WHILE MINIMISING SYSTEMIC SIDE EFFECTS. IN UROLOGICAL SURGERIES SPINAL ANESTHESIA IS THE PREFERRED TECHNIQUE DUE TO ITS RAPID ONSET , PREDICTABLE EFFECT AND COST EFFECTIVENESS.A RANDOMISED CONTROLLED DOUBLE BLINDED STUDY IS DONE BETWEEN PATIENTS RECEIVING ISOBARIC LEVOBUPIVACAINE AND HYPERBARIC BUPIVACAINE IN PATIENTS UNDERGOING ELECTIVE UROLOGIC SURGERIES UNDER SPINAL ANESTHESIA. TOTAL SAMPLE SIZE IS 74, WITH 37 PARTICIPANTS IN EACH GROUP.

THE INCLUSION AND EXCLUSION CRITERIA ARE FOLLOWED . INFORMED AND WRITTEN CONSENT FROM PATIENTS WILL BE OBTAINED.PATIENTS WILL BE SHIFTED TO OT ,IV ACCESS WILL BE SECURED, ON THE FOREARM ,IV FLUIDS WILL BE STARTED. MULTIPARA MONITORS WILL BE CONNECTED , UNDER ASEPTIC PRECAUTIONS UNDER SPINAL ANESTHESIA THE DRUG WILL BE ADMINISTERED .HEART RATE , BP, ECG, RR, SPO2, VAS SCALE MODIFIED  BROMAGE  SCALE ARE MONITORED AND STUDIED.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator Blinded

入排标准

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

入选标准

  • PATIENTS POSTED FOR ELECTIVE UROLOGIC SURGERIES UNDER SPINAL ANESTHESIA AGE GROUP OF 18-65 YEARS OF AGE BELONGING TO ASA CLASS I AND CLASS II.

排除标准

  • Patient refusal to spinal anesthesia Contraindications to spinal anesthesia like Bleeding disorders and coagulation abnormalities Raised Intracranial pressure Having neurological deficits History of severe migraine and headache.

结局指标

主要结局

To compare the onset, duration of sensory and motor blockade in

时间窗: MODIFIED BROMAGE SCALE HR, SBP, DBP, MAP, ECG, RR, SPO2

patients receiving 0.5% isobaric Levobupivacaine [group L] and patients receiving 0.5%

时间窗: MODIFIED BROMAGE SCALE HR, SBP, DBP, MAP, ECG, RR, SPO2

hyperbaric Bupivacaine [group B] in patients undergoing urologic surgeries.

时间窗: MODIFIED BROMAGE SCALE HR, SBP, DBP, MAP, ECG, RR, SPO2

次要结局

  • To compare the intraoperative hemodynamic changes between two groups(To evaluate the adverse effects between the groups)

研究者

发起方
SNEHA ANAND
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

SNEHA ANAND

SREE VENKATESHWARA MEDICAL COLLEGE HOSPITAL AND RESEARCH INSTITUTE

研究点 (1)

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