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临床试验/CTRI/2023/07/055823
CTRI/2023/07/055823已完成Unknown

Study of effect of nebulised Dexmedetomidine on onset and duration of Spinal Anaesthesia- a one year hospital based randomised clinical trial

Other1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2023年4月8日最近更新:

试验速览

阶段
Unknown
状态
已完成
发起方
Other
入组人数
80
试验地点
1
主要终点
To study the effect of nebulised Dexmedetomidine on onset and duration of sensor and motor block in Spinal Anaesthesia

研究概览

简要总结

After obtaining approval from the Ethical Committee, and applying inclusion and exclusion criteria, subjects undergoing infra-umbilical surgery in supine position under Spinal anaesthesia will be included in the study.Data collection procedure:

In the Pre-operative area

 After obtaining approval and consent for the study, patient’s details are elicited, and NBM status is confirmed.

Pulse Oximeter, NIBP, ECG leads are attached and baseline reading is taken in the Preoperative room.

Patient will be shifted into the OT. Baseline pulse,NIBP and SpO2 will be recorded.

Patient will then receive Spinal anaesthesia in L3-L4 space with 3.2ml of 0.5% Hyperbaric Bupivacaine. Intraoperative Pulse, SpO2, NIBP will be monitored every 5 minutes upto 30 minutes and then every 10 minutes till the end of surgery.

After the action of spinal anaesthesia, patient will receive nebulisaion.

Group I will receive dexmedetomidine nebulisation with maximum of 1mcg/kg diluted with Normal Saline upto 5 ml.

 Patients in Group II will receive nebulisation with 5 ml of saline.

Onset of Sensory and Motor blockade is noted. Onset and duration of Sensory blockade is noted with cold swab.

Motor blockade is assessed with Bromage Scale with the following score:-

0-   No paralysis

1-      Unable to flex hip, but able to flex knees and ankle

2-      Unable to flex hips and knees, but able to flex ankles

3-      Unable to flex ankles, only able to move toes.

4-      Total paralysis

Time for regression of sensory block by 2 segments is noted as duration of Sensory Blockade.

Duration of time taken for Bromage score 0 to return is noted as duration of Motor blockade.

Intraoperative fall in HR over 15% of baseline will be treated with Inj. Atropine 0.6mg IV while fall in BP>20% will be treated with 3 mg of Mephentermine IV if required.

Intraoperatively sedation will be assessed using Ramsay sedation score every half hourly till the duration of surgery or for 3 hours whichever is longer.

Post Operatively- Pain will be evaluated using the VAS Scale. When VAS>3, patient will receive Inj. Paracetamol 15mg/Kg BW. The time at which patient asks for analgesic is noted and the total analgesic consumption in the First 24 hours is noted.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Not Applicable

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • ASA grade I to II Patients undergoing elective infra-umbilical surgery under Spinal Anaesthesia.

排除标准

  • Patients with ASA Grade III and above Patients contraindication to Spinal Anaesthesia Patients with known allergy to Dexmedetomidine Patients on pre-operative drugs that could be potential confounders such as Clonidine, Gabapentin, Pregabalin, Steroids etc.

结局指标

主要结局

To study the effect of nebulised Dexmedetomidine on onset and duration of sensor and motor block in Spinal Anaesthesia

时间窗: Monitored every 5 min upto 30 minutes then every 10 minutes upto the end of surgery

次要结局

  • Time for first rescue analgesia(Total analgesic requirement in the first 24 hours post-operatively)

研究者

发起方
Other
申办方类型
Other [self]

研究点 (1)

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