CTRI Number |
CTRI/2023/07/055646 [Registered on: 25/07/2023] Trial Registered Prospectively |
Last Modified On: |
25/07/2023 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Drug Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
Comparison of two medicines, Phenylephrine and Norepinephrine for managing low blood pressure occurring after spinal anaesthesia in planned caesarian cases. |
Scientific Title of Study
|
Norepinephrine vs. Phenylephrine in the management of post-spinal hypotension in patients undergoing elective caesarean section:
A double-blinded randomized clinical trial
|
Trial Acronym |
NIL |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr. Hariharan Kannan |
Designation |
Assistant Professor |
Affiliation |
KMCH Institue of Health Sciences and Research |
Address |
B Block, 7th Floor,
Department of Anaesthesia
99 A, Avinashi Road,
Coimbatore
Coimbatore TAMIL NADU 641014 India |
Phone |
8105564983 |
Fax |
|
Email |
dr.hariharankannan@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr. Hariharan Kannan |
Designation |
Assistant Professor |
Affiliation |
KMCH Institue of Health Sciences and Research |
Address |
B Block, 7th Floor,
Department of Anaesthesia
99 A, Avinashi Road,
Coimbatore
Coimbatore TAMIL NADU 641014 India |
Phone |
8105564983 |
Fax |
|
Email |
dr.hariharankannan@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr. Hariharan Kannan |
Designation |
Assistant Professor |
Affiliation |
KMCH Institue of Health Sciences and Research |
Address |
B Block, 7th Floor,
Department of Anaesthesia,
99 A, Avinashi Road,
Coimbatore
Coimbatore TAMIL NADU 641014 India |
Phone |
8105564983 |
Fax |
|
Email |
dr.hariharankannan@gmail.com |
|
Source of Monetary or Material Support
|
KMCH Institute of Medical Sciences & Research
99 A, Avinashi Road,
Coimbatore - 641014,
Tamil Nadu, India |
|
Primary Sponsor
|
Name |
Dr Hariharan Kannan |
Address |
B Block, 7th Floor,
Department of Anaesthesia,
KMCH Institute of Health Sciences and Research,
99A, Avinashi Road, Coimbatore, Tamil Nadu, India - 641014
|
Type of Sponsor |
Other [] |
|
Details of Secondary Sponsor
|
Name |
Address |
KMCH Institue of Health Sciences and Research |
99A, Avinashi Road, Coimbatore, Tamil Nadu, India - 641014 |
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr Hariharan Kannan |
KMCH Institue of Health Sciences and Research |
B Block, 7th Floor,
99A, Avinashi Road, Coimbatore, Tamil Nadu, India - 641014 Coimbatore TAMIL NADU |
8105564983
dr.hariharankannan@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
KMCH Institue of Health Sciences and Research Institutional Human Ethics Committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: O82||Encounter for cesarean delivery without indication, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Norepinephrine vs Phenylephrine for treatment of post spinal hypotension |
4 mcg norepinephrine or 50 mcg phenylephrine to be given to patients undergoing elective caesarean section to treat hypotension following spinal anaesthesia. |
Comparator Agent |
Norepinephrine vs Phenylephrine for treatment of post spinal hypotension |
4 mcg norepinephrine or 50 mcg phenylephrine to be given to patients undergoing elective caesarean section to treat hypotension following spinal anaesthesia. |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
40.00 Year(s) |
Gender |
Female |
Details |
Mothers with singleton term pregnancy undergoing elective caesarean section under spinal anaesthesia |
|
ExclusionCriteria |
Details |
Mothers with complications such as
1. Hypertensive disorders complicating pregnancy
2. Other cardiovascular/cerebrovascular disease, peripheral vascular thrombosis
3. Contra-indications for spinal anaesthesia
4. Multiple pregnancy
5. Known foetal abnormality
6. Primigravida above 35 years of age
7. And those receiving monoamine oxidase inhibitors or tricyclic antidepressants
|
|
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 |
umbilical artery pH |
At delivery of baby |
|
Secondary Outcome
|
Outcome |
TimePoints |
APGAR Score |
1 min & 5 min following delivery |
Maternal haemodynamic parameters such as Heart rate, Blood Pressure, Arrythmias |
End of surgery |
Maternal morbidity such as nausea, vomitin, shivering |
End of Surgery |
|
Target Sample Size
|
Total Sample Size="86" Sample Size from India="86"
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 3/ Phase 4 |
Date of First Enrollment (India)
|
01/08/2023 |
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) |
Open to Recruitment |
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
|
Background: Post-spinal hypotension is a common complication with incidence as high as 30-90%. This may lead to adverse maternal and foetal outcomes such as nausea, emesis, light headedness, impair uterine and intervillous blood flow, and result in foetal acidosis and neonatal depression. The aim of this study is to compare bolus doses of Phenylephrine and Norepinephrine for treating hypotension in mothers undergoing elective caesarean section under spinal anaesthesia. Methods: Eight-six pregnant mothers with singleton pregnancy posted for caesarean section will be randomly assigned to either Phenylephrine group or a Norepinephrine group. An assessor blind to group allocation will measure umbilical artery pH obtained from blood samples sent for blood gas analysis from a segment of umbilical cord double clamped before the baby’s first breath, Apgar scores at 1 min and 5 min, birth weight, the number of hypotensive episodes, vasopressor requirements, the incidence of tachycardia/bradycardia/ arrhythmias/hypertension and maternal complications such as nausea and vomiting, and shivering. It is hypothesized that Phenylephrine has better neonatal and maternal outcomes, and has better efficacy in treating hypotension when compared to Norepinephrine. Discussion: If the study proves that Norepinephrine is more beneficial vis-a-vis Phenylephrine as vasopressor to maintain blood pressure and cardiac output following spinal anaesthesia, it could lead to increased use of Norepinephrine with benefits to neonatal outcomes and better maternal haemodynamic control. |