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临床试验/CTRI/2023/10/059271
CTRI/2023/10/059271尚未招募不适用

Effect of two doses of Intravenous Dexamethasone on Duration of Spinal Anesthesia in Lower Segment Cesarean Section Surgeries-A Randomised Controlled Trial

Shree Krishna Hospital1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2023年11月30日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
64
试验地点
1
主要终点
Will get to know the effect of dexamethasone on duration of spinal anesthesia

研究概览

简要总结

Patients undergoing lower segment caesarean section under spinal anesthesia will be recruited in this study. Pre-anesthetic check up will be carried out in all patients. Participants will be allotted in to two groups through balanced randomization.In group-A patient will receive 4mg intravenous injection dexamethasone and in group-B patient will receive 8mg intravenous injection dexamethasone 15 minutes prior to giving spinal anaesthesia. On arrival to operation theatre, Standard intraoperative monitoring- electrocardiogram, pulse oximetry and noninvasive blood pressure will be attached and baseline vitals will be noted. Under all aseptic precautions spinal anaesthesia will be performed in sitting position at L3-L4 space for lower Segment caesarean section using 23G Quincke spinal needle. After free flow of cerebrospinal fluid, inj. hyperbaric Bupivacaine (0.5%) 10mg will be slowly injected.

Sensory and motor level will be evaluated by blind individual every 30 seconds for first 5 minutes, 1 minute till 10 minutes, every 5 minutes till 30 minutes and every 30 minutes till patients will be in post anesthesia care unit. Sensory block will be checked bilaterally at mid-clavicular line using pinprick method. The onset time of sensory block will be defined as time from drug administration until bilateral T10 level of sensory blockade is achieved. The duration of sensory block will be considered as time from the highest level of sensory blockade until 4 segment regression were observed. Motor block will be checked by Modified Bromage Scale (MBS). The onset time of motor blockage will be defined as time from drug injection until a grade-3 MBS is achieved. The regression of motor block will be considered as the time from full intensity motor blockade until a MBS grade-0 is achieved.

Clinically relevant hypotension will be defined as decrease in systolic arterial pressure 20% or more from base line. In that case, Inj. epinephrine 6mg will be given. Bradycardia will be defined as decrease in heart rate to 20% or more from the baseline heart rate. Inj Atropine 0.6mg will be given in such scenarios. Incidence of nausea vomiting will be recorded intraoperatively and will be treated with Inj. Ondensatron 8mg IV. Additional analgesia with Inj.Paracetamol 1gm will be given on visual analougue score(VAS) more than 4. Incidence of peri-operative shivering will be notyed and treated with warming blanket and if not relieved, then by inj.tramadol 25mg iv.

For assessing recovary of patient after 24 hr, we will use ObsQoR-11 questionnaries also been translated into gujarati language by forward and backward translation method for easy understanding of patient.The questionnaries will be containing 11 questions to be asked to the patient 24 hrs after cesarean delivery and will be rated according to patients agreement and disagreement.

研究设计

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

入排标准

年龄范围
18.00 Year(s) 至 40.00 Year(s)(—)
性别
Female

入选标准

  • Patient undergoing Lower Segment cesarean section under spinal anesthesia with American Society of Anesthesiologist Physical Status grade||-|||.

排除标准

  • High risk pregnancy-Eclampsia,Preeclampsia,Abruption Placenta,Placenta previa,Cord prolapse,Absolute contraindication to spinal anesthesia,patient on steriod therapy or past history of medication with steriods in last 1 year,Patient with diabetes or gestational diabetes,Allergy to local anesthetic drug.

结局指标

主要结局

Will get to know the effect of dexamethasone on duration of spinal anesthesia

时间窗: 15 minutes prior to giving spinal anesthesia

次要结局

未报告次要终点

研究者

申办方类型
Private medical college

研究点 (1)

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