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CTRI Number  CTRI/2020/11/029196 [Registered on: 18/11/2020] Trial Registered Prospectively
Last Modified On: 17/11/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to compare spinal anaesthesia with general anaesthesia using drugs given intravenously for early discharge to home. 
Scientific Title of Study   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 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  M KEERTHIVASAN 
Designation  POST GRADUATE 
Affiliation  SRM Medical College Hospital 
Address  Department of Anaesthesia SRM Medical College and Hospital Potheri

Kancheepuram
TAMIL NADU
603203
India 
Phone  9444304482  
Fax    
Email  keerthivasanm94@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  M KEERTHIVASAN 
Designation  POST GRADUATE 
Affiliation  SRM Medical College Hospital 
Address  Department of Anaesthesia SRM Medical College and Hospital Potheri

Kancheepuram
TAMIL NADU
603203
India 
Phone  9444304482  
Fax    
Email  keerthivasanm94@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Venkatraman 
Designation  Professor 
Affiliation  SRM medical college and Hospital 
Address  Department of Anaesthesia SRM Medical College Hospital and Research Centre Potheri kancheepuram

Kancheepuram
TAMIL NADU
603203
India 
Phone  9894581455  
Fax    
Email  drvenkat94@gmail.com  
 
Source of Monetary or Material Support  
SRM Institute of science and technology 
 
Primary Sponsor  
Name  SRM Institute of science and technology 
Address  SRM Nagar Potheri-603203  
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
MKeerthivasan  SRM Medical College Hospital  Room NO-1 B block Department of Anaesthesia SRM Medical College Hospital
Kancheepuram
TAMIL NADU 
9444304482

keerthivasanm94@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SRM Medical College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N201||Calculus of ureter,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Spinal Anaesthesia   Spinal anesthesia given in L3 -L4 space about 12.5mg plain Bupivacaine Heavy given 
Intervention  Total intravenous Anaesthesia  The drug propofol 3to4mcg/ml administered intravenously through target control infusion pump to induce and maintain anaesthesia till the end of the procedure  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ASA 1 and ASA 2
Duration of surgery about 30min to 120min
Patients with ureteric calculi
 
 
ExclusionCriteria 
Details  Pregnancy
Contraindication to spinal anaesthesia
Drug allergy
Patient refusal
Spinal failure
Difficult airway
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare early attainment of Modified Post anaesthetic discharge scoring system  To compare early attainment of Modified Post anaesthetic discharge scoring system 
 
Secondary Outcome  
Outcome  TimePoints 
To compare
Time to Discharge from recovery room by Modified Aldrete score
Visual analogue scale every hour till attainment of discharge criteria
 
Aldrete score of more than 9 of 10 
Complications like nausea,vomiting,hypotension ,bradycardia  First 24hours after surgery 
 
Target Sample Size   Total Sample Size="66"
Sample Size from India="66" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   18/11/2020 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NA 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
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.

 
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