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临床试验/CTRI/2025/01/078873
CTRI/2025/01/078873尚未招募不适用

Intravenous Dexamethasone versus Intravenous Normal Saline in Prolonging the Effect of Spinal Anesthesia in Lower Abdominal and Lower Limb Surgeries Randomized Control Trial

Rohilkhand Medical College and Hospital1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年1月30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
80
试验地点
1
主要终点
1. Onset of sensory & motor blockade

研究概览

简要总结

Spinal anesthesia has significantly evolved, offering various techniques and adjuvants to enhance efficacy and patient outcomes. Notably, the intravenous dexamethasone as soon as the patient is lied supine after the hyperbaric ropivacaine 3ml given intrathecally is of great interest. This study tells us about the efficacy of the intravenous dexamethasone in prolonging the effect of spinal anesthesia and also how it reduces the need for the post op analgesia.

Hyperbaric ropivacaine produces more reliable motor or sensory blocks with faster onset. Also it has better result as it has less central nervous system toxicity and is more cardio stable has lesser episodes of hypotension.

Dexamethasone is strong and selective glucocorticoid with minimal mineralocorticoid effect. Immunosuppressive properties and anti-inflammatory properties of dexamethasone if given intravenously might be in charge of the analgesic’s prolonged duration postoperatively

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant, Investigator and Outcome Assessor 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

  • American society of Anesthesiologist (ASA) grade I or II and Patient having elective procedures on lower limbs and abdomen.

排除标准

  • 1.Patient refusal for the procedure 2.Infection at the site 3.Any abnormality of spinal anatomy 4.Allergy or intolerance to regional anesthesia 5.Coagulopathy or Bleeding disorder.

结局指标

主要结局

1. Onset of sensory & motor blockade

时间窗: for sensory blockade the time to assess will be by pin prick sensation every 2min till loss at T06 dermatome and motor till the modified bromage grade 3 occurs. | after the surgery, the time needed for the 1st rescue analgesia will be noted

2. Highest level of sensory block

时间窗: for sensory blockade the time to assess will be by pin prick sensation every 2min till loss at T06 dermatome and motor till the modified bromage grade 3 occurs. | after the surgery, the time needed for the 1st rescue analgesia will be noted

3. Time for two segment regression of sensory

时间窗: for sensory blockade the time to assess will be by pin prick sensation every 2min till loss at T06 dermatome and motor till the modified bromage grade 3 occurs. | after the surgery, the time needed for the 1st rescue analgesia will be noted

block

时间窗: for sensory blockade the time to assess will be by pin prick sensation every 2min till loss at T06 dermatome and motor till the modified bromage grade 3 occurs. | after the surgery, the time needed for the 1st rescue analgesia will be noted

4. Duration of motor blockade

时间窗: for sensory blockade the time to assess will be by pin prick sensation every 2min till loss at T06 dermatome and motor till the modified bromage grade 3 occurs. | after the surgery, the time needed for the 1st rescue analgesia will be noted

5. Time for first rescue analgesic

时间窗: for sensory blockade the time to assess will be by pin prick sensation every 2min till loss at T06 dermatome and motor till the modified bromage grade 3 occurs. | after the surgery, the time needed for the 1st rescue analgesia will be noted

6. Incidence of post-operative nausea, vomiting

时间窗: for sensory blockade the time to assess will be by pin prick sensation every 2min till loss at T06 dermatome and motor till the modified bromage grade 3 occurs. | after the surgery, the time needed for the 1st rescue analgesia will be noted

and post spinal shivering.

时间窗: for sensory blockade the time to assess will be by pin prick sensation every 2min till loss at T06 dermatome and motor till the modified bromage grade 3 occurs. | after the surgery, the time needed for the 1st rescue analgesia will be noted

次要结局

  • Hemodynamic parameters (Heart rate, systolic(and diastolic blood pressure, mean arterial)

研究者

发起方
Rohilkhand Medical College and Hospital
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Richa Chandra

Rohilkhand medical college and hospital

研究点 (1)

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