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临床试验/CTRI/2020/11/029196
CTRI/2020/11/029196尚未招募不适用

Comparison of spinal anaesthesia with general anaesthesia using target control infusion for early attainment of discharge criteria in patients undergoing day care ureteroscopic lithotripsy-A Randomized Control Trial

SRM Institute of science and technology1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2020年11月18日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
66
试验地点
1
主要终点
To compare early attainment of Modified Post anaesthetic discharge scoring system

研究概览

简要总结

Patients satisfying inclusion and exclusion criteria will be taken up for the study .Patients randomly allocated into Group S and Group T done by computer generated randomization. Patients will be explained about the study methodology and proper consent will be obtained.

In both the groups patient will be Pre medicated with Tab.Alprazolam 0.25mg P/O  night before surgery and 2hours before on the day of surgery .Inj.Ondansetron 4mg iv will be given half an hour before surgery.

In group S patient in sitting posture under aseptic precaution using 25Gauge Quincke’s spinal needle in L3-L4 lumbar space Inj.0.5% Bupivacaine Heavy 12.5mg will be given. Patient positioned to supine and after 5min positioned to Lithotomy for surgery.

In group T patient in supine posture Pre oxygenated with 100% oxygen .Injection Fentanyl 2mcg kg-1 stat dose given intravenously .With set target plasma concentration of 3mcgml-1Propofol using  TCI pump with Schnider’s model will be given .Plasma concentration will be increased from 3to4mcg ml-1 if there is no proper jaw relaxation or hemodynamic changes .LMA insertion will be done once plasma concentration reaches set target plasma concentration .Patient will be positioned to Lithotomy for surgery.

Throughout the procedure anaesthesia will be maintained with set target control infusion with Propofol, O2 and N20in 2:1 ratio without volatile agent under spontaneous ventilation .After the procedure once lithotomy position is removed target control infusion will be stopped. LMA will be removed once the patient is awake and responding .

Throughout the procedure vitals will be monitored. Patient will be shifted to recovery room for further monitoring .Postoperatively both groups will receive Inj.paracetamol1gm iv at the end of surgery and then 6hrly.

For rescue analgesia Inj.Tramadol 100mg iv will be given along with Inj.Ondansetron 4mg iv if the VAS score is ≥ 4 with minimum 8hours interval

Patient will be followed postoperatively for 12hrs and modified Post anaesthestic discharge scoring system will be assessed after 6 hours of surgery and then every half an hour till attainment of discharge criteria

Patients will be informed about complication like Nausea, Vomiting ,Headache ,Pain and Bleeding at the time of discharge and asked to get re admit if they have any of the above complication.

Patient will be followed till 72hrs through phone call for Post Dural puncture headache and other complications .Patients satisfying inclusion and exclusion criteria will be taken up for the study .Patients randomly allocated into Group S and Group T done by computer generated randomization. Patients will be explained about the study methodology and proper consent will be obtained.

In both the groups patient will be Pre medicated with Tab.Alprazolam 0.25mg P/O  night before surgery and 2hours before on the day of surgery .Inj.Ondansetron 4mg iv will be given half an hour before surgery.

In group S patient in sitting posture under aseptic precaution using 25Gauge Quincke’s spinal needle in L3-L4 lumbar space Inj.0.5% Bupivacaine Heavy 12.5mg will be given. Patient positioned to supine and after 5min positioned to Lithotomy for surgery.

In group T patient in supine posture Pre oxygenated with 100% oxygen .Injection Fentanyl 2mcg kg-1 stat dose given intravenously .With set target plasma concentration of 3mcgml-1Propofol using  TCI pump with Schnider’s model will be given .Plasma concentration will be increased from 3to4mcg ml-1 if there is no proper jaw relaxation or hemodynamic changes .LMA insertion will be done once plasma concentration reaches set target plasma concentration .Patient will be positioned to Lithotomy for surgery.

Throughout the procedure anaesthesia will be maintained with set target control infusion with Propofol, O2 and N20in 2:1 ratio without volatile agent under spontaneous ventilation .After the procedure once lithotomy position is removed target control infusion will be stopped. LMA will be removed once the patient is awake and responding .

Throughout the procedure vitals will be monitored. Patient will be shifted to recovery room for further monitoring .Postoperatively both groups will receive Inj.paracetamol1gm iv at the end of surgery and then 6hrly.

For rescue analgesia Inj.Tramadol 100mg iv will be given along with Inj.Ondansetron 4mg iv if the VAS score is ≥ 4 with minimum 8hours interval

Patient will be followed postoperatively for 12hrs and modified Post anaesthestic discharge scoring system will be assessed after 6 hours of surgery and then every half an hour till attainment of discharge criteria

Patients will be informed about complication like Nausea, Vomiting ,Headache ,Pain and Bleeding at the time of discharge and asked to get re admit if they have any of the above complication.

Patient will be followed till 72hrs through phone call for Post Dural puncture headache and other complications.

研究设计

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

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 1 and ASA 2 Duration of surgery about 30min to 120min Patients with ureteric calculi.

排除标准

  • Pregnancy Contraindication to spinal anaesthesia Drug allergy Patient refusal Spinal failure Difficult airway.

结局指标

主要结局

To compare early attainment of Modified Post anaesthetic discharge scoring system

时间窗: To compare early attainment of Modified Post anaesthetic discharge scoring system

次要结局

  • To compare(Time to Discharge from recovery room by Modified Aldrete score)
  • Complications like nausea,vomiting,hypotension ,bradycardia(First 24hours after surgery)

研究者

申办方类型
Private medical college

研究点 (1)

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