A study to compare spinal anaesthesia with general anaesthesia using drugs given intravenously for early discharge to home.
- Conditions
- Calculus of ureter,
- Registration Number
- CTRI/2020/11/029196
- Lead Sponsor
- SRM Institute of science and technology
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 66
ASA 1 and ASA 2 Duration of surgery about 30min to 120min Patients with ureteric calculi.
Pregnancy Contraindication to spinal anaesthesia Drug allergy Patient refusal Spinal failure Difficult airway.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare early attainment of Modified Post anaesthetic discharge scoring system To compare early attainment of Modified Post anaesthetic discharge scoring system
- Secondary Outcome Measures
Name Time Method To compare Time to Discharge from recovery room by Modified Aldrete score Complications like nausea,vomiting,hypotension ,bradycardia First 24hours after surgery
Trial Locations
- Locations (1)
SRM Medical College Hospital
🇮🇳Kancheepuram, TAMIL NADU, India
SRM Medical College Hospital🇮🇳Kancheepuram, TAMIL NADU, IndiaMKeerthivasanPrincipal investigator9444304482keerthivasanm94@gmail.com