| CTRI Number |
CTRI/2024/06/069129 [Registered on: 18/06/2024] Trial Registered Prospectively |
| Last Modified On: |
11/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparision of prophylactic infusion of Phenylephrine versus Norepinephrine for the prevention of post spinal hypotension in parturients undergoing elective caesaeran section-A double blinded,randomised controlled trial |
|
Scientific Title of Study
|
Comparision of prophylactic infusion of Phenylephrine versus Norepinephrine for the prevention of post spinal hypotension in parturients undergoing elective caesaeran section-A double blinded, non inferiority, randomised controlled 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 |
DrAnil Kumar Ganeshnavar |
| Designation |
Professor |
| Affiliation |
S.Nijalingappa Medical College |
| Address |
Department of Anaesthesiology,S.N.M.C and HSK Hospital,Navanagar,Bagalkot
Bagalkot
Karnataka
Bagalkot
KARNATAKA
587102
India |
| Phone |
9964526598 |
| Fax |
|
| Email |
anilganesh22@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrAnil Kumar Ganeshnavar |
| Designation |
Professor |
| Affiliation |
S.Nijalingappa Medical College |
| Address |
S.Nijalingappa Medical College
Department of Anaesthesiology
Bagalkot
Karnataka
Bagalkot
KARNATAKA
587102
India |
| Phone |
9964526598 |
| Fax |
|
| Email |
anilganesh22@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rachana R |
| Designation |
Junior Resident |
| Affiliation |
S.Nijalingappa Medical College |
| Address |
Department of Anaesthesiology,S.N.M.C and HSK Hospital,Navanagar
Bagalkot
Karnataka
Bagalkot
KARNATAKA
587102
India |
| Phone |
9964526598 |
| Fax |
|
| Email |
rachanaranganath96@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia,S.Nijalingappa Medical College and HSK Hospital,Bagalkot -587102 |
| S.Nijalingappa Medical College |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesia |
| Address |
S.Nijalingappa Medical College and HSK Hospital,Bagalkot 587102. Karnataka,India |
| 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 |
| DrAnilkumar Ganeshnavar |
Department of Anaesthesia,HSK Hospital and Research Centre |
S.Nijalingappa Medical College and HSK Hospital,Navanagar,Bagalkot-587102,Karnataka,India
Bagalkot
KARNATAKA |
9964526598
anilganesh22@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| S.Nijalingappa Medical College Institutional Ethics Committee and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: O748||Other complications of anesthesiaduring labor and delivery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Parturients undergoing Elective Caesarean section |
Patients will be fasted overnight and will given IV metoclopramide 10 mg and Pantoprazole 40 mg iv. On arrival to the operating room , electrocardiogram, non-invasive blood pressure (BP), and SpO2 monitors will be attached. Baseline heart rate (HR) and BP will be noted with the patient in supine position with left lateral tilt. An 18G IV cannula will be placed and coloading will be achieved using 500 mL of lactated Ringer solution. Another wide-bore cannula will be placed in the in the contralateral arm.
Participants will be randomly allocated into 2 groups using computer generated random number tables.
Group B participants will receive Norepinephrine 5mcg/min iv at 15ml/hr.
Subarachnoid block (SAB) will be administered by an experienced anaesthesiologist with 12.5 mg 0.5% bupivacaine heavy in the L3-L4 interspace using a 25 G Quincke needle with the patient in the sitting position. After the block, patients will be made supine with left lateral tilt, and vasopressor infusion will be started at 15 mL/ hr according to the group allocation and observed for 60 minutes. |
| Intervention |
Paturients undergoing Elective caesarean section |
Patients will be fasted overnight and will given IV metoclopramide 10 mg and Pantoprazole 40 mg iv.On arrival to the operating room , electrocardiogram, non-invasive blood pressure (BP), and SpO2 monitors will be attached. Baseline heart rate (HR) and BP will be noted with the patient in supine position with left lateral tilt. An 18G IV cannula will be placed and coloading will be achieved using 500 mL of lactated Ringer solution. Another wide-bore cannula will be placed in the in the contralateral arm.Participants will be randomly allocated into 2 groups using computer generated random number tables.Group A participants will receive Phenylephrine 50mcg/min iv at 15ml/hr.
Subarachnoid block (SAB) will be administered by an experienced anaesthesiologist with 12.5 mg of bupivacaine heavy 0.5% in the L3-L4 interspace using a 25 G Quincke needle with the patient in the sitting position. After the block, patients will be made supine with left lateral tilt, and vasopressor iv infusion will be started at 15 mL/ hr according to the group allocation and observed for 60 minutes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
American Society of Anaesthesiologist grade
Non labouring,normotensive parturients
Term singleton pregnancy
Posted for Elective caesarean section under Spinal anaesthesia
|
|
| ExclusionCriteria |
| Details |
Known fetal abnormality,
Pre existing or pregnancy-induced hypertension,
Known cardiovascular or cerebrovascular disease,
Allergy or hypersensitivity to study drugs
Thrombocytopenia, coagulopathy, or any medical contraindication to spinal
anaesthesia
Weight-50-100kg
Height-140 or 180cm
Patients who refused to give consent |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To measure proportion of hypotension between 2 groups |
1 hour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Secondary objectives - incidence of maternal bradycardia, nausea and vomiting, reactive hypertension, requirement of rescue boluses of vasopressor and atropine between the 2 groups. |
1 hour |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
24/06/2024 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Spinal anaesthesia is the technique of choice for elective caesarean delivery; however this technique results in hypotension in the vast majority of women if not actively prevented. The consequences of spinal hypotension in this setting are proportional to the severity and include nausea and vomiting, decrease in uteroplacental blood flow, fetal acidosis, and rarely, cardiovascular collapse. Without prophylactic Vasopressors, post spinal hypotension affects neatly 60% of women during caesarean delivery; thus using vasopressors have been highly recommended for routine prevention of post spinal hypotension during caesarean delivery. Phenylephrine is a potent α -adrenergic receptor agonist as emerged as the vasopressor of choice for management of post spinal hypotension. It’s use is often associated with a dose related reflexive slowing of maternal heart rate(HR) and a corresponding decrease in cardiac output(CO).Although the clinical significance of these decreases in HR and CO in healthy patients with unstressed fetuses is unknown, concern has been expressed that there may be potential for harm in the presence of a compromised fetus. Hence the use of norepinephrine which is characterized by α -adrenergic agonistic activity in addition to a weak β -adrenergic agonistic activity, is recommended as vasopressor with minimal cardiac depressant effect to prevent maternal hypotension. These pharmacologic properties would make norepinephrine an attractive alternative to phenylephrine and ephedrine in obstetric anaesthesia. We postulated that norepinephrine might therefore be an effective vasopressor for maintaining blood pressure during spinal anaesthesia with less tendency to decrease Heart rate and Cardiac output. |