| CTRI Number |
CTRI/2024/12/077977 [Registered on: 11/12/2024] Trial Registered Prospectively |
| Last Modified On: |
05/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective observational study |
| Study Design |
Other |
|
Public Title of Study
|
Phenylephrine boluses versus continuous infusion for preventing post spinal hypotension in low risk pregnant patients undergoing elective caesarean section |
|
Scientific Title of Study
|
Phenylephrine boluses vs continuous infusion for preventing post spinal hypotension in low risk parturients undergoing elective caesarean section- A prospective observational study |
| 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 Jose Paul |
| Designation |
Senior Resident |
| Affiliation |
Kerala University of Health Sciences |
| Address |
Department of Anaesthesiology
Al Azhar Medical College and Super Speciality Hospital
Thodupuzha
Idukki
Kerala
India
685605
Idukki
KERALA
685605
India |
| Phone |
9447840994 |
| Fax |
|
| Email |
joseparackal62@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manjit George |
| Designation |
Professor and HOD |
| Affiliation |
Kerala University of Health Sciences |
| Address |
Room no: 12
Division: 5
Department of Anaesthesiology
Al Azhar Medical College and Super Speciality Hospital
Thodupuzha
Idukki
Kerala
India
685605
Idukki
KERALA
685605
India |
| Phone |
9447411536 |
| Fax |
|
| Email |
manjitgeorge@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jose Paul |
| Designation |
Senior Resident |
| Affiliation |
Kerala University of Health Sciences |
| Address |
Room no: 12
Division: 5
Department of Anaesthesiology
Al Azhar Medical College and Super Speciality Hospital
Thodupuzha
Idukki
Kerala
India
685605
Idukki
KERALA
685605
India |
| Phone |
9447840994 |
| Fax |
|
| Email |
joseparackal62@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room no: 12
Division: 5
Department of Anaesthesiology
Al Azhar Medical College and Super Speciality Hospital
Thodupuzha
Idukki
Kerala
India
685605 |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology |
| Address |
Room no: 12
Division: 5
Department of Anaesthesiology
Al Azhar Medical College and Super Speciality Hospital
Thodupuzha
Idukki
Kerala
India
685605 |
| 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 Jose Paul |
Al Azhar Mediacal College and Super Speciality Hospital |
Room no: 12
Division: 5
Department of Anaesthesiology
Al Azhar Medical College and Super Speciality Hospital
Thodupuzha
Idukki
Kerala
India
685605
Idukki
KERALA |
9447840994
joseparackal62@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AL AZHAR MEDICAL COLLEGE AND SUPER SPECIALITY HOSPITAL -INSTITUTIONAL ETHICS COMMITTEE |
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 |
nil |
nil |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
elective cesarean section
ASA 2
|
|
| ExclusionCriteria |
| Details |
Cesarean section under general anesthesia
ASA grade 3 and above
hypotension associated with bradycardia
emergency cesarean section
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of hypotension during procedure |
30 seconds
1 minute
1 minute 30 seconds
2 minutes
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
maternal and fetal complications
adverse effects of phenylephrine
maternal satisfaction and recovery time |
30 mins
60 mins
90 mins
120 mins
150 mins
180 mins |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
30/12/2024 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
Hypotension remains the most common complication following spinal anaesthesia, potentially leading to adverse maternal and foetal outcomes. Intravenous vasopressors such as Phenylephrine, Ephedrine and Mephenteramine are widely used to manage this. Prospective observational study at Al- Azhar Medical College and Superspecialty Hospital with a duration of 6 months. Study population include low risk parturients undergoing elective caesarean section. Sample size is 90.The study will be started after getting permission. Informed consent will be obtained from the patient prior to study participation. Patients will be divided into two groups A and B. Group A includes patients receiving Phenylephrine continous infusion. Group B includes patients receiving Phenylephrine intermittent boluses.All patients in our study undergoing caesarean section will be receiving spinal anaesthesia in sitting position using 25G whitacre/ Quincke needle. The drug administered intrathecally will be 0.5% Bupivacaine Heavy 2.2 mls. A sensory level of T5 will be ensured before the start of surgery. Group A will receive iv continuous infusion of phenylephrine at 0.5-0.6mcg/kg/min started immediately after spinal anesthesia and continued until Pitocin bolus is given after baby delivery. BP will be measured every minute. iv bolus of 50 mcg phenylephrine will be given if bp drops to less than 80 percentage of base line values. If HR falls below 50/min or if the SBP goes above 20% of baseline, the infusion of Phenylephrine will be held until it recovers. Patients in Group B will receive intermittent boluses of Phenylephrine 25 mcg iv every 3rd minute after spinal anaesthesia and this will be continued until Pitocin bolus is given after baby delivery and BP will be recorded every minute. iv bolus of 50 mcg phenylephrine will be given when bp falls less than 80% baseline. If HR falls below 50/min or if the SBP goes above 20% of baseline, the next dose of intermittent bolus will be held until it recovers. After 1 minute of spinal anesthesia, heart rate, SBP and DBP are recorded every minute until baby delivery. After baby delivery, apgar score will be measured at 1 minute and 5 minutes.Primary outcome is Incidence of
hypotension during the procedure (BP drops to less than 80 percentage of base line).Secondary
outcomes is maternal and fetal complications , adverse effects of phenylephrine, maternal satisfaction and recovery time |