跳至主要内容
临床试验/CTRI/2024/01/061502
CTRI/2024/01/061502尚未招募不适用

A comparative study on the block characteristics in spinal anaesthesia with premixed or succedent administration of hyperbaric bupivacaine and fentanyl in lower segment caesarean section

BIDYA NGANGOM1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年1月20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
60
试验地点
1
主要终点
DURATION OF ANALGESIA (time to demand of first rescue analgesia assessed by visual analogue scale)

研究概览

简要总结

The study will be a prospective randomized double blinded study to assess and compare the effects of premixed or succedent intrathecal administration of 25 mcg fentanyl citrate with 0.5% bupivacaine (2ml , heavy) in parturient undergoing LSCS procedures under subarachnoid block.

A total of 60 parturient will be selected for the study and divided into 2 groups of 30 patients each viz. group A (n-30) and group B (n-30). According to block randomization, patients in group A will be administered premixed 2ml of 0.5% bupivacaine heavy plus 0.5 ml  (25mcg) fentanyl citrate with a 5 ml syringe and group B will be administered 2ml of 0.5% bupivacaine heavy in a 5ml syringe followed by 0.5 ml (25mcg) fentanyl citrate with a 2ml syringe in the subarachnoid space L3-L4. in both the groups, the study drugs will be administered  at a rate of 0.2ml/min. The block characteristics along with regression of the blockade, side effects (if any) and the hemodynamic changes will be observed, assessed and recorded by blinded investigator using the modified bromage scale, VAS, sedation scale.

The data collected will be collected and analyzed using student t test for continuous data and chi square test for categorical data as and where appropriate.

研究设计

研究类型
Interventional
分配方式
Permuted block randomization, fixed
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 45.00 Year(s)(—)
性别
Female

入选标准

  • PARTURIENT WITH AMERICAN SOCIETY OF ANAESTHESIOLOGISTS (ASA) I OR II AGED 18-45 YEARS UNDERGOING LOWER SEGMENT CAESAREAN SECTION UNDER SPINAL ANAESTHESIA.

排除标准

  • a) HISTORY OF ALLERGY TO STUDY DRUGS b) BLEEDING DISORDER- PLATELET COUNT -<50,000/MICROLITRE, PROTHROMBIN TIME>14 SEC, INR >1.5 c) LOCAL SITE INFECTION d) CARDIAC,RESPIRATORY DISEASES AND KIDNEY DISORDER, NEUROLOGICAL DEFICIT d) SPINAL DEFORMITY.

结局指标

主要结局

DURATION OF ANALGESIA (time to demand of first rescue analgesia assessed by visual analogue scale)

时间窗: Time (in minutes) to demand of first rescue analgesia assessed by visual analogue scale (VAS score more than 4)

次要结局

  • 1)HAEMODYNAMIC PROFILE-SBP,DBP,MAP,SPO2(2)SENSORY BLOCK ONSET AT T10)

研究者

发起方
BIDYA NGANGOM
申办方类型
Other [POST GRADUATE TRAINING]

研究点 (1)

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