| CTRI Number |
CTRI/2022/08/044705 [Registered on: 17/08/2022] Trial Registered Prospectively |
| Last Modified On: |
20/08/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare phenylephrine and nor epinephrine boluses for the treatment of post spinal hypotension during elective caesarean section |
|
Scientific Title of Study
|
A STUDY TO EVALUATE PHENYLEPHRINE AND NOR EPINEPHRINE BOLUSES FOR THE TREATMENT OF HYPOTENSION POST SPINAL ANAESTHESIA FOR ELECTIVE CAESAREAN SECTION. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Reddy Gnanendra Prasad |
| Designation |
Junior Resident |
| Affiliation |
DR B R Ambedkar Medical College and Hospital |
| Address |
Major OT Complex,Department of Anaesthesiology, DR B R
Ambedkar Medical College and Hospital,K G Halli,Bangalore
Bangalore
KARNATAKA
560045
India |
| Phone |
9535422875 |
| Fax |
|
| Email |
reddy.svis@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Santosh kumar |
| Designation |
Associate Professor |
| Affiliation |
DR B R Ambedkar Medical College and Hospital |
| Address |
Major OT Complex,Department of Anaesthesiology, DR B R
Ambedkar Medical College and Hospital,K G Halli,Bangalore
Bangalore
KARNATAKA
560045
India |
| Phone |
9845785715 |
| Fax |
|
| Email |
drsantoshkumarcc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Santosh kumar |
| Designation |
Associate Professor |
| Affiliation |
DR B R Ambedkar Medical College and Hospital |
| Address |
Major OT Complex,Department of Anaesthesiology, DR B R
Ambedkar Medical College and Hospital,K G Halli,Bangalore
KARNATAKA
560045
India |
| Phone |
9845785715 |
| Fax |
|
| Email |
drsantoshkumarcc@gmail.com |
|
|
Source of Monetary or Material Support
|
| DR B R Ambedkar Medical College and Hospital,K G Halli,Bangalore. |
|
|
Primary Sponsor
|
| Name |
Dr Santosh Kumar |
| Address |
DR B R Ambedkar Medical College and Hospital
K G Halli
Bangalore |
| Type of Sponsor |
Private medical college |
|
|
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 Y Reddy Gnanendra Prasad |
DR B R AMBEDKAR MEDICAL COLLEGE AND HOSPITAL |
Major OT Complex,Department of Anaesthesiology, DR B R Ambedkar Medical College and Hospital,K G Halli.
Bangalore
KARNATAKA |
9535422875
reddy.svis@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institution ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O759||Complication of labor and delivery, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NOR EPINEPHRINE 100mcg IV |
A COMPARATIVE STUDY TO EVALUATE PHENYLEPHRINE AND NOR EPINEPHRINE BOLUSES FOR THE TREATMENT OF POST SPINAL HYPOTENSION DURING ELECTIVE CAESAREAN SECTION-[PHENYLEPHRINE NORADRENALINE CAESAREAN SECTION SAB] |
| Intervention |
phenylephrine 100 mcg IV |
A COMPARATIVE STUDY TO EVALUATE PHENYLEPHRINE AND NOR EPINEPHRINE BOLUSES FOR THE TREATMENT OF POST SPINAL HYPOTENSION DURING ELECTIVE CAESAREAN SECTION-[PHENYLEPHRINE NORADRENALINE CAESAREAN SECTION SAB] |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1.Patients posted for Elective cesarean section.
2.Patient aged between 20-35 years.
3.Patients belonging to American Society of Anaesthesiologists (ASA) grade I and II . |
|
| ExclusionCriteria |
| Details |
1.patient refusal.
2.Patients with altered coagulation profile / bleeding diathesis.
3.Pre existing neurological or cardiac
diseases.
4.Alcoholism, drug abuse, psychological or other emotional problems that are likely to invalidate the informed consent, or limit the ability of the subject to comply with the protocol requirements
were excluded. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To Study the number of bolus doses of
Phenylephrine and nor epinephrine needed to treat hypotension following Spinal Anaesthesia during Elective caesarean delivery |
Base line, during spinal, position, every 3 minutes till the baby delivered and after that every 5 mins till the end of surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare incidence of nausea and vomiting in mother |
45 minutes to 180 minutes |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
N/A |
|
Date of First Enrollment (India)
|
20/08/2022 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Study to compare the number of bolus doses of Phenylephrine and nor epinephrine needed to treat hypotension following Spinal Anaesthesia during Elective caesarean delivery. Hypotension is a common side effect of spinal anesthesia for cesarean section, with an incidence of up to 71% . Maternal hypotension produces unpleasant symptoms such as nausea, vomiting, and dizziness. Prompt treatment of hypotension with intravenous fluids and vasopressor is necessary to avoid detrimental maternal effects. Use of vasopressors, which lead to an increase in systemic vascular resistance and rise in mean arterial pressures, have been traditionally used for the prevention and management of hypotension after spinal anaesthesia. |