| CTRI Number |
CTRI/2023/11/060261 [Registered on: 28/11/2023] Trial Registered Prospectively |
| Last Modified On: |
25/11/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Other (Specify) [Hemodynamic variability after giving position ] |
| Study Design |
Other |
|
Public Title of Study
|
Hemodynamic changes after position in spinal anesthesia is compared on 30seconds,1minute and immediately lying down position. |
|
Scientific Title of Study
|
Comparison of 30 seconds and 1 minute sitting position vs Immediately lying down on hemodynamic variable after spinal anesthesia in elective cesarean section |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Raavi swapna lakshmi priya |
| Designation |
Junior resident |
| Affiliation |
DR.D.Y.PATIL MEDICAL COLLEGE,HOSPITAL AND RESEARCH CENTRE |
| Address |
Dr.D.Y.Patil Medical College Hospital And Research Centre,carnation girls hostel,A-35Sant Tukaram Nagar,Pimpri,Pune
Dr.D.Y.Patil Medical College Hospital And Research Centre,carnation girls hostel,A-35,Sant Tukaram Nagar,Pimpri,Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9494901213 |
| Fax |
|
| Email |
swapnapriyanani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Maj Gen S Hasnain(Retd) |
| Designation |
professor |
| Affiliation |
DR.D.Y.PATIL MEDICAL COLLEGE,HOSPITAL AND RESEARCH CENTRE |
| Address |
Dr.D.Y.Patil Medical College Hospital And Research Centre,Sant Tukaram Nagar,Pimpri,Pune
Dr.D.Y.Patil Medical College Hospital And Research Centre,Sant Tukaram Nagar,Pimpri,Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9764621253 |
| Fax |
|
| Email |
shahbazhsnn@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Raavi swapna lakshmi priya |
| Designation |
Junior resident |
| Affiliation |
DR.D.Y.PATIL MEDICAL COLLEGE,HOSPITAL AND RESEARCH CENTRE |
| Address |
Dr.D.Y.Patil Medical College Hospital And Research Centre,carnation hostel A-35,Sant Tukaram Nagar,Pimpri,Pune
Dr.D.Y.Patil Medical College Hospital And Research Centre,Carnation hostel A-35,Sant Tukaram Nagar,Pimpri,Pune
MAHARASHTRA
411018
India |
| Phone |
9494901213 |
| Fax |
|
| Email |
swapnapriyanani@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr.Y.Patil medical college,Central pharmacy,hightech ot -5th floor |
|
|
Primary Sponsor
|
| Name |
DRSWAPNA LAKSHMI PRIYA |
| Address |
Dr.D.Y.Patil Medical College Hospital And Research Centre,Carnation hostel,Sant Tukaram Nagar,Pimpri,Pune |
| Type of Sponsor |
Other [] |
|
|
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 |
| DrSwapna lakshmi priya |
Dr.Y.Patil Medical College |
carnation hostel A-35,Department of Anesthesia,Junior resident.
Pune
MAHARASHTRA |
9494901213
swapnapriyanani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS SUB COMMITEE,DR.D.Y.PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
ASA I AND ASAII |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bupivacaine heavy 2.2cc, Intrathecal route Immediately lying down position |
To compare the hemodynamic variables on immediately lying down after giving spinal anaesthesia in elective cesarean section |
| Intervention |
Bupivacaine heavy 2.2cc, Intrathecal route, lying down after 1 minute position |
To compare the hemodynamic variables on lying down after 1 minute of giving spinal anaesthesia in elective cesarean section |
| Intervention |
Bupivacaine heavy 2.2cc, Intrathecal route, lying down after 30 seconds |
To compare the hemodynamic variables on lying down after 30 seconds after giving spinal anaesthesia in elective cesarean section |
| Comparator Agent |
Bupivacaine heavy 2.2cc,Intrathecal route |
To compare the hemodynamic variables on lying down after 1 minute of giving spinal anaesthesia in elective cesarean section |
| Comparator Agent |
Bupivacaine heavy 2.2cc,Intrathecal route |
To compare the hemodynamic variables on immediately lying down after giving spinal anaesthesia in elective cesarean section |
| Comparator Agent |
Bupivacaine heavy2.2cc,Intrathecal route |
To compare the hemodynamic variables on lying down after 30 seconds after giving spinal anaesthesia in elective cesarean section |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
ASA grade I and II
Ages between 18 to 65 yrs.
Patients undergoing elective cesarean section.
Haemodynamically stable patients with all routine investigations with in normal limits.
Availability of an informed consent. |
|
| ExclusionCriteria |
| Details |
Patient refusal
Preeclampsia
Chronic hypertension
Diabetes
Allergy to drugs used in the study.
Contraindication to neuraxial anesthesia.
Blood pressure below 90mmhg and heart rate below50/min.
Need for general anesthesia.
Addiction or drug abuse.
Anyobstretic emergency.
ASA III and above. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Hemodynamic variable after spinal anesthesia in elective ceserean section in 30sec and 1minute vs immediately lying down position. |
Baeline,30seconds,1,2,3,5 minutes,10,15,20,25,30 minutes,40,50,60 minutes. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Hemodyanamic variable and sensory blockade after spinal spinal anesthesia in 30sec,1minute vs immediately lying down position. |
Baeline,30seconds,1,2,3,5 minutes,10,15,20,25,30 minutes,40,50,60 minutes. |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
03/12/2023 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
It is a randomized prospective study for comparison of 30 sec ,1minute and immediately lying down position on hemodynamic variable after spinal anesthesia in elective cesarean section and aslo the use of vasopressors and level achieved after the position. |