| CTRI Number |
CTRI/2023/06/054376 [Registered on: 23/06/2023] Trial Registered Prospectively |
| Last Modified On: |
22/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Preventive |
| Study Design |
Other |
|
Public Title of Study
|
To compare the incidence of hypotension and bradycardia by using two sympathomimetic drugs ,phenylephrine and noradrenaline among patients undergoing cesarean section under spinal anesthetia |
|
Scientific Title of Study
|
Comparison of prophylactic infusion of norepinephrine and phenylephrine for the maintenance of hemodynamics following subarachnoid block during cesarean section: an interventional double blind randomised trial |
| Trial Acronym |
No |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ysurekha |
| Designation |
Post graduate |
| Affiliation |
Karnataka Institute of medical sciences |
| Address |
DrY Surekha,postgraduate,department of Anaesthesiology,room no 206,second floor,Karnataka Institute of medical sciences vidyanagar
Hubbali
Dharwad-580032
Vidyanagar,
Hubbali
Dharwad
580032
Dharwad
KARNATAKA
580032
India |
| Phone |
9032909554 |
| Fax |
|
| Email |
rekhamedico96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sushma KS |
| Designation |
Associate Professor |
| Affiliation |
Karnataka Institute of medical sciences, |
| Address |
Dr Sushma KS, Associate professor,Department of Anaesthesiology, Karnataka Institute of medical sciences vidyanagar, Hubbali, Dharwad, Karnataka,
Hubbali
Dharwad
Dr Sushma Ks,Associate Professor,Department of Anaesthesiology,Karnataka Institute of medical sciences, Vidyanagar,Hubbali
Dharwad, Karnataka
580032
Dharwad
KARNATAKA
580032
India |
| Phone |
9844310403 |
| Fax |
|
| Email |
dr.sushsam@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sushma KS |
| Designation |
Associate Professor |
| Affiliation |
Karnataka Institute of medical sciences |
| Address |
Dr Sushma KS, Associate Professor,Department of Anaesthesiology,Karnataka Institute of medical sciences vidyanagar, hubbali, dharwad
Hubbali
Dharwad
Dr Sushma KS, Associate Professor,Department of Anaesthesiology,Karnataka Institute of medical sciences,Hubbali, Dharwad, 580032,Karnataka
Dharwad
580032
Dharwad
KARNATAKA
580032
India |
| Phone |
9844310403 |
| Fax |
|
| Email |
dr.sushsam@gmail.com |
|
|
Source of Monetary or Material Support
|
| Karnataka Institute of medical sciences, vidyanagar, hubbali |
|
|
Primary Sponsor
|
| Name |
Dr Y Surekha |
| Address |
Postgraduate, Department of Anaesthesiology,Karnataka Institute of medical sciences vidyanagar ,hubbali |
| 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 |
| Y surekha |
Karnataka Institute of medical sciences |
Department of Anaesthesiology, Room number 206,vidyanagar,hubbali, 580032,Dharwad.
Dharwad
KARNATAKA |
9032909554
rekhamedico96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Karnataka Institute of Medical Sciences, Hubballi Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O295||Other complications of spinal andepidural anesthesia during pregnancy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Norepinephrine |
Prophylactic infusion of Norepinephrine at 2.5 mcg/hr from the time of incision to till delivery of the baby |
| Comparator Agent |
Phenylephrine |
Prophylactic infusion of Phenylephrine at 50 mcg/hr from the time of incision to till delivery of the baby |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1)Parturients with uncomplicated term singleton pregnancy undergoing elective cesarean delivery and belonging to American Society of Anaesthesiologists classification 2
2) Age 18 to 35 yrs
3) Parturients giving informed written and valid consent |
|
| ExclusionCriteria |
| Details |
1) parturients having hypertensive disorders of pregnancy, diabetes milletus, cardiac, cerebrovascular, renal disorders, oligohydramnios, IUGR.
2) parturients having hypersensitivity to any of the study drugs
3) parturients with known contraindications to spinal anaesthesia |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the incidence of bradycardia among phenylephrine and norepinephrine groups |
Measuring HR every 1 minute from onset of spinal action till delivery of baby |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Incidence of hypotensive episodes, maternal systolic and diastolic blood pressure, MAP,number of boluses of vasopressors required, reactive hypertension. |
Measuring, BP and MAP every one minute from onset of spinal anaesthesia to delivery of the baby |
|
|
Target Sample Size
|
Total Sample Size="128"
Sample Size from India="128"
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 4 |
|
Date of First Enrollment (India)
|
10/07/2023 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a type of randomised double blind interventional study where norepinephrine and Phenylephrine infusions will be given prophylactically in less dose and comparing those two drugs and observing which will prevent bradycardia in parturients undergoing cesarean section. Totally 2 groups, each group containing 64 persons. So total sample size will be 128 . |