| CTRI Number |
CTRI/2016/12/007541 [Registered on: 07/12/2016] Trial Registered Prospectively |
| Last Modified On: |
16/05/2018 |
| 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
|
Comparison of phenylephrine and norepinephrine boluses for treatment of fall in blood pressure during planned caesarean section under spinal anaesthesia |
|
Scientific Title of Study
|
Randomized double blind comparison of phenylephrine and norepinephrine boluses for treatment of post-spinal hypotension during 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 Medha Mohta |
| Designation |
Director Professor |
| Affiliation |
University College of Medical Sciences and Guru Teg Bahadur Hospital |
| Address |
Department of Anaesthesiology and Critical Care
University College of Medical Sciences and Guru Teg Bahadur Hospital,
Delhi
East
DELHI
110095
India |
| Phone |
9868399626 |
| Fax |
|
| Email |
medhamohta@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ankita |
| Designation |
Post-graduate student |
| Affiliation |
University College of Medical Sciences and Guru Teg Bahadur Hospital |
| Address |
Department of Anaesthesiology and Critical Care
University College of Medical Sciences and Guru Teg Bahadur Hospital,
Delhi
East
DELHI
110095
India |
| Phone |
9821183677 |
| Fax |
|
| Email |
ankitagarg179@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Medha Mohta |
| Designation |
Director Professor |
| Affiliation |
University College of Medical Sciences and Guru Teg Bahadur Hospital |
| Address |
Department of Anaesthesiology and Critical Care
University College of Medical Sciences and Guru Teg Bahadur Hospital,
Delhi
East
DELHI
110095
India |
| Phone |
9868399626 |
| Fax |
|
| Email |
medhamohta@hotmail.com |
|
|
Source of Monetary or Material Support
|
| University College of Medical Sciences and Guru Teg Bahadur Hospital, Dilshad Garden, Delhi-110095 |
|
|
Primary Sponsor
|
| Name |
University College of Medical Sciences and Guru Teg Bahadur Hospital |
| Address |
University College of Medical Sciences and Guru Teg Bahadur Hospital, Dilshad Garden, Delhi-110095 |
| Type of Sponsor |
Government 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 Medha Mohta |
University College of Medical Sciences and GTB Hospital |
Department of Anaesthesiology and Critical Care, 2nd Floor, OT Block, University College of Medical Sciences and Guru Teg Bahadur Hospital,Dilshad Garden
East
DELHI |
9868399626
medhamohta@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee-Human Research (University College of Medical Sciences, Delhi) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Spinal Anaesthesia induced Hypotension in Elective caesarean section, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group Norepinephrine |
Norepinephrine 5 microg IV will be given for treatment of each hypotensive value of blood pressure till the time of delivery |
| Comparator Agent |
Group Phenylephrine |
Phenylephrine 100 microg IV will be given for treatment of each hypotensive value of blood pressure till the time of delivery
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Healthy females with term, uncomplicated, singleton pregnancy undergoing elective caesarean section under spinal anaesthesia |
|
| ExclusionCriteria |
| Details |
• Maternal complications e.g. diabetes, pre-eclampsia, cardiovascular disease, cerebrovascular disease, renal impairment
• Placental complications viz., placenta praevia or abruptio placentae
• Cord complications viz., nuchal cord or cord prolapse
• Fetal malformations
• Multiple gestation
• Patients with absolute or relative contra-indications for spinal anaesthesia e.g. infection in lumbar area, coagulation abnormalities, autonomic neuropathy, spinal deformities, other neurological diseases, hypovolemia due to any cause
• Patients on monoamine oxidase inhibitors or tricyclic antidepressants
• Presence of mesenteric or peripheral vascular thrombosis
• Maternal baseline SBP less than 100 mmHg
• Patients with baby birth weight less than 2.5 kg or greater than 4.5 kg |
|
|
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 |
| incidence of maternal bradycardia (HR less than 60) |
till delivery of baby |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• Changes in maternal SBP after vasopressor administration
• Number of episodes of hypotension
• Total number of vasopressor doses given
• Incidence of reactive hypertension and arrhythmias
• Incidence of nausea, vomiting, dizziness or any other complications
• Apgar scores at 1 and 5 minutes
• Umbilical artery pH
• Incidence of fetal acidosis, defined as umbilical artery pH less than 7.20 |
till delivery of baby |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "90"
Final Enrollment numbers achieved (India)="90" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
09/12/2016 |
| Date of Study Completion (India) |
23/01/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a randomized, double blind, parallel group trial comparing phenylephrine and norepinephrine for the treatment of post-spinal hypotension in patients undergoing elective caesarean section. Post-spinal hypotension, defined as fall of SBP 20% or more from the baseline or an absolute SBP less than100 mm Hg, whichever is higher; will be treated with inj. phenylephrine 100 microg iv or inj. norepinephrine 5 microg iv. Umbilical arterial and venous blood samples of the fetus will be obtained from a segment of umbilical cord double clamped before the baby’s first breath for blood gas analysis. The primary outcome measure will be incidence of maternal bradycardia (HR below 60 per minute). The secondary outcome measures will be change in maternal SBP, number of episodes of hypotension, total vasopressor doses given, Apgar scores at 1 and 5 minutes, incidence of fetal acidosis (defined as umbilical artery pH less than 7.20), incidence of tachycardia/bradycardia/ arrhythmias/hypertension, incidence of nausea, vomiting, dizziness or any other complications. |