| CTRI Number |
CTRI/2019/03/017979 [Registered on: 07/03/2019] Trial Registered Prospectively |
| Last Modified On: |
01/03/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of two anaesthesia techniques for day care surgeries |
|
Scientific Title of Study
|
A RANDOMIZED CONTROL TRIAL COMPARING SPINAL ANAESTHESIA WITH GENERAL ANAESTHESIA ON DISCHARGE CRITERIA FOR DAY CARE URETEROSCOPIC SURGERIES |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gayathri |
| Designation |
Professor |
| Affiliation |
SRMCHRC |
| Address |
Department of Anesthesiology
Room No 209
seconfd floor
SRM Medical College Hospital
SRM Nagar
Kattankulathur
Chennai
603201
Department of Anesthesiology
Room No 209
seconfd floor
SRM Medical College Hospital
SRM Nagar
Kattankulathur
Chennai
603201
Chennai
TAMIL NADU
6003203
India |
| Phone |
9500092905 |
| Fax |
|
| Email |
gayathrii.r@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
B Gayathri |
| Designation |
Professor |
| Affiliation |
SRMCHRC |
| Address |
Department of Anesthesiology
Room No 209
seconfd floor
SRM Medical College Hospital
SRM Nagar
Kattankulathur
Chennai
603201
Department of Anaesthesiology
Room No 211
SRM Nagar Kattankulathur
Chennai
Chennai
TAMIL NADU
6003203
India |
| Phone |
9500092905 |
| Fax |
|
| Email |
gayathrii.r@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aiswarya Sriniivasan |
| Designation |
Post graduate student |
| Affiliation |
SRMCHRC |
| Address |
Department of Anaesthesia
Room no 209
Second floor
SRM Medical College Hospital
SRM Nagar
Kattankulathur
Chennai
603203
Second floor
SRM Medical College Hospital
SRM Nagar
Kattankulathur
Chennai
603203
Chennai
TAMIL NADU
603203
India |
| Phone |
8428468813 |
| Fax |
|
| Email |
ayshwarya.s@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr.Gayathri B
Professor Anaesthesiology
Department of Anaesthesiology
Room n 209, Second floor
SRM Medical College and research centre
SRM Nagar Kattankulathur
Chennai
600203 |
|
|
Primary Sponsor
|
| Name |
SRM Medical College |
| Address |
Department Anaesthesithesiology
Room No 209
SRMMCHRC
SRM Nagar
Kattankulathur
Chennai
Tamilnadu
India |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| GAYATHRI |
SRM Medical College Hospital and Research Centre |
Department of Anaesthesithesiology
Room mumber 209 Second floor
SRM Nagar KATTANKULATHUR Chennai
Kancheepuram
TAMIL NADU |
9500092905
gayathrii.r@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC SRM MCH AND RC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N211||Calculus in urethra, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Technique used: Sub arachanoid block |
Spinal anaesthesia given with
Dose:0.75% Isobaric Ropivacaine, with 25 microgram Fentany using 25 G needle
Duration: Maximum time taken for giving spinal 1 min
Frequency: Single injection
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA 1 AND 2 patients
2. Patients posted for ureterolithotrypsy |
|
| ExclusionCriteria |
| Details |
1. Urinary tract infection.
2. Patients with contra indications for spinal anesthesia.
3. Patients with coronary artery disease
4. Patients with deranged renal parameters 5. Patients with deranged coagulation
5. Patients with deranged liver parameters.
6.Patient with history of bronchial asthma or chronic obstructive pulmonary disease.
7. Patients with allergy to any study medications.
8. ASA (American Society of Anaesthesiology) category III and IV.
9. Patient refusal for one or other technique of anaesthesia.
10.Surgeon requests for specific anaesthesia technique.
11.Pregnancy.
12. Patient refusal.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Aldrete score 10 |
Sameday |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Haemodynamics |
same day |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
30/04/2019 |
| Date of Study Completion (India) |
01/08/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
01/08/2020 |
|
Estimated Duration of Trial
|
Years="0"
Months="5"
Days="20" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Published in Indian Journal of Clinical Anaesthesia Current Volume - 7 | Issue - 4 | Year - 2020 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
AIM: The aim of the study is to compare the effect of spinal anesthesia with general anesthesia on discharge criteria for day care ureteroscopic procedures. · Primary objective: Attainment of discharge criteria · Secondary objective: to evaluate hemodynamics and occurrence of complications (Pain , Post operative nausea and vomiting). Methodology: As per randomization cases are done under SA or GA((LMA Spontaneous) under standardized monitoring protocol Shifted to Phase 1 recovery area where Aldrete score is checked. Patients are shifted to phase 2 recovery area when Aldrete score is 10 In Phase 2 recovery, monitoring continued for HR, NIBP, and Saturation. Patients will be made to sit in the bed with support in the 2nd hour (120 min). During this time patients will be assessed for nausea. If no nausea complained, they will be encouraged to drink water. At 2.5 hours (150 min) after surgery patients will be encouraged to sit at the edge of the cot with legs dangling down. At 3 hours (180 min) they will be encouraged to stand with support (Staffs holding on either side). In spinal group standing was encouraged only after confirming return of Bromage to 1 (No detectable weakness in lower limbs). If the patient had no complaint of giddiness they will be encouraged to walk from 4th hour (240 min). PADSS score (Post anaesthesia discharge scoring system) which includes vital signs, gait, mental status, pain nausea and vomiting will be recorded in all patients from 4th hour (240 min) till score of 9 was achieved. Patients will be discharged from phase 2 recovery at the end of 360 minutes i.e., 6th hour after reconfirming whether they have achieved PADSS score of 9. (In our patients PADSS of 10 will not be achieved as they will be catheterized). Before discharge from phase 2 cognitive ability of patients using digit symbol substitution test method will be done. Patient will be assessed for pain using VAS score and anytime VAS is above 4, rescue analgesic Inj. Tramadol 100mg IV will be given. During recovery stay presence of complications like nausea, vomiting and shivering will be also recorded. The surgeon was asked to grade their comfort during surgery which is recorded as satisfactory score. (4-excellent, 3- Good, 2- fair, 1-poor). Results will be submitted to statistical analysis |