| CTRI Number |
CTRI/2024/02/062991 [Registered on: 21/02/2024] Trial Registered Prospectively |
| Last Modified On: |
26/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
The study to compare two different dose of norepinephrine based on weight of the patient for preventing fall in blood pressure after spinal anaesthesia in patients undergoing cesarean section |
|
Scientific Title of Study
|
Randomised double blind study of comparing two weight adjusted doses of norepinephrine for preventing hypotension during spinal anaesthesia for elective Caesarean 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 |
SK SAIF ALI |
| Designation |
Post graduate resident M.D Anaesthesiology |
| Affiliation |
Sri Ramachandra institute of higher education and research |
| Address |
Room no: A-6 anaesthesia department,Sri Ramachandra institute of higher education and research,Ramachandra nagar,Porur,chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
8895706873 |
| Fax |
|
| Email |
saifali669@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr ARUNA PARAMESWARI |
| Designation |
Professor and Head of department |
| Affiliation |
SRI Ramachandra institute of higher education and research |
| Address |
Room no: A-6 anaesthesia department,Sri Ramachandra institute of higher education and research,Ramachandra nagar,Porur,chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
9840529863 |
| Fax |
|
| Email |
reetharun@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SK SAIF ALI |
| Designation |
second year post graduate resident M.D Anaesthesiology |
| Affiliation |
SRI Ramachandra institute of higher education and research |
| Address |
Room no: A-6 anaesthesia department,Sri Ramachandra institute of higher education and research,Ramachandra nagar,Porur,chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
8895706873 |
| Fax |
|
| Email |
saifali669@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Ramachandra institute of higher education and research |
|
|
Primary Sponsor
|
| Name |
SK Saif ali |
| Address |
Room no A6 anaesthesia department,Sri Ramachandra institute of higher education and research, Ramachandra nagar,Porur,Chennai-600116 |
| Type of Sponsor |
Other [Self financing ] |
|
|
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 |
| Dr SK Saif ali |
Sri Ramachandra institute of higher education and research |
Department of anaesthesia,Operating room division room number-A6
Chennai
TAMIL NADU |
8895706873
saifali669@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee,Sri Ramachandra institute of higher education and research,Porur,chennai-600116 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Norepinephrine infusion for preventing hypotension in elective lower segment cesarean section |
weight adjusted dose of norepinephrine infusion at concentration of 0.05mcg//kg/min . And infusion is started immediately after spinal anaesthesia through intravenous route at rate of 5ml/hr and hemodynamics are measured at 0 minute then every 1minute till the baby is delivered and access it’s efficacy in prevention of hypotension |
| Comparator Agent |
Weight adjusted separate concentration of norepinephrine in elective lower segment cesarean section |
Weight adjusted dose of norepinephrine infusion at concentration of 0.075mcg/kg/min.And infusion is started immediately after spinal anaesthesia through intravenous route at rate of 5ml/hr and hemodynamics are measured at 0minute then every 1minute till the baby is delivered and access it’s efficacy in prevention of hypertension |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1)full term women undergoing elective cesarean section
2) ASA class II
3)age between 18-35 years |
|
| ExclusionCriteria |
| Details |
1) patients refusal
2)hypertensive disorders
3)cardiac diseases
4)allergy to local anaesthetics
5)obstretic complications (antepartum hemorrhage,placenta privea,placental abruption)
6)coagulopathy,sepsis,hepatic or renal failure |
|
|
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 |
1)Doses of rescue bolus of phenylephrine 20 mcg
2)access incidence of hypotension in both groups |
Incidence of hypotension is assessed immediately after spinal anaesthesia measurement of blood pressure every 1 minute after spinal till the delivery of baby and the amount of PHENYLEPHERINE boluses used during the intraoperative period. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)intraoperative blood pressure(systolic and diastolic h
Pressure)
2)mean arterial pressure
3)post operative shivering |
1)intraoperative blood pressure at baseline and 1minute after spinal anaesthesia till end of the procedure
2)post operative shivering accessed after giving spinal anaesthesia and in the post anaesthetic care unit
3)mean arterial pressure at baseline and 1 minute after giving spinal anaesthesia till the end of procedure |
|
|
Target Sample Size
|
Total Sample Size="170"
Sample Size from India="170"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="170" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
21/02/2024 |
| Date of Study Completion (India) |
24/05/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Hypotension is the most common complication seen in patients undergoing Caesarean section under spinal anaesthesia.Norepinephrine infusion has been suggested as an effective method for preventing hypotension during spinal anaesthesia for elective Caesarean section. Norepinephrine associated with less propensity to reduce heart rate and cardiac output owing to its mild beta adrenergic agonist effects.our study compares norepinephrine infusion with two different combinations in elective Caesarean section under spinal anaesthesia |