| CTRI Number |
CTRI/2024/01/061641 [Registered on: 19/01/2024] Trial Registered Prospectively |
| Last Modified On: |
03/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare effect of phenylephrine infusion versus normal saline on intraoperativ e hemodynamics, shivering, hypothermia in casearean section under spinal anesthesia |
|
Scientific Title of Study
|
A comparative evaluation of effect of phenylephrine infusion versus normal saline infusion on intraoperative hemodynamics, shivering, hypothermia in patient undergoing cesarean section under spinal anesthesia |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrMeenakshiN |
| Designation |
Post Graduate in Department of Anaesthesiology |
| Affiliation |
Rajarajeswari medical college and hospital |
| Address |
Department of Anaesthesiology
Rajarajeswari Medical College and hospital
Mysore Road
Kambipura
Bangalore
KARNATAKA
Bangalore
KARNATAKA
560074
India |
| Phone |
9566746452 |
| Fax |
|
| Email |
meenakshin.14@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrSudheer |
| Designation |
Professor |
| Affiliation |
Rajarajeswari medical college and hospital |
| Address |
Department of Anaesthesiology
Rajarajeswari Medical College and hospital
Mysore Road
Kambipura
Bangalore
KARNATAKA
Bangalore
KARNATAKA
560074
India |
| Phone |
9741117754 |
| Fax |
|
| Email |
sudheerramegowda81@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrSudheer |
| Designation |
Professor |
| Affiliation |
Rajarajeswari medical college and hospital |
| Address |
Department of Anaesthesiology
Rajarajeswari Medical College and hospital
Mysore Road
Kambipura
Bangalore
KARNATAKA
Bangalore
KARNATAKA
560074
India |
| Phone |
9741117754 |
| Fax |
|
| Email |
sudheerramegowda81@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology
2nd floor Rajarajeshwari medical college and hospital
Bangalore 560074 |
|
|
Primary Sponsor
|
| Name |
Dr.Meenakshi.N |
| Address |
Department of Anaesthesiology
Rajarajeswari Medical College and hospital
Mysore Road
Kambipura
Bangalore
KARNATAKA |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| DrSudheer |
Rajarajeswari medical college and hospital |
Department of Anaesthesiology
Rajarajeswari Medical College and hospital
Mysore Road
Kambipura
Bangalore
KARNATAKA
Bangalore
KARNATAKA |
9741117754
sudheerramegowda81@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: 1||Obstetrics, (2) ICD-10 Condition: 1||Obstetrics, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Normal saline infusion |
Patients undergoing ceserean section under spinal anesthesia will be divided into Group N will recieve Normal saline infusion at 15ml/hr, intravenous administration, duration of 50 minutes intraoperatively |
| Intervention |
Phenylephrine infusion |
Patients under cesearean section under spinal anesthesia will be divided into Group P will recieve intravenous phenylephrine infusion at dose of 1mcg/kg/min,intravenous route of administartion,total duration upto 50 minutes. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Patients undergoing elective cesarean section |
|
| ExclusionCriteria |
| Details |
Patient refusal
Hypertensive disorder in pregnancy
Cardiac disease
Antepartum haemorrhage
Known allergy to drug used in study
Patient posted for emergency LSCS
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Primary outcome is prevention of hypotension |
shivering, hypothermia baseline and every 5 minutes for 50 minutes intraoperatively.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Hemodynamic parameters like NIBP,HR intraoperatively
Prevention of nausea and vomiting
Prevention of shivering |
Intraoperative period |
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
22/01/2024 |
| 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="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
|
Spinal anesthesia induced hypotension is a common problem and is associated with maternal nausea and vomiting,fetal acidosis.Aim of this study is to compare efficacy of phenylephrine infusion and normal saline infusion to prevent hypotension , nausea, vomiting, shivering. |