| CTRI Number |
CTRI/2023/07/055528 [Registered on: 24/07/2023] Trial Registered Prospectively |
| Last Modified On: |
21/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare effect of nor epinephrine and phenylephrine in cases of blood pressure decrease in pregnant women undergoing emergency cesarean section under spinal anaesthesia. |
|
Scientific Title of Study
|
To compare bolus doses of nor epinephrine and phenylephrine for treatment of maternal hypotension undergoing emergency lower segment cesarean section under subarachnoid block : A Randomized Clinical 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 Rajat Kathpal |
| Designation |
Post Graduate Student |
| Affiliation |
Maharaja Agarsen Medical College,Agroha,Hisar,Haryana |
| Address |
Department of Anaesthesia,
Division-Operation Theatre Complex,
Room No-120,
Maharaja Agarsen Medical College,
Agroha,Hisar,Haryana
Hisar
HARYANA
125047
India |
| Phone |
9896683083 |
| Fax |
|
| Email |
dr.rajatkathpal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vibha Mehta |
| Designation |
Professor |
| Affiliation |
Maharaja Agarsen Medical College,Agroha,Hisar,Haryana |
| Address |
Department of Anaesthesia,
Division-Operation Theatre Complex,
Room No-120,
Maharaja Agarsen Medical College,
Agroha,Hisar,Haryana
Hisar
HARYANA
125047
India |
| Phone |
9466088221 |
| Fax |
|
| Email |
drvibhamehta1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vibha Mehta |
| Designation |
Professor |
| Affiliation |
Maharaja Agarsen Medical College,Agroha,Hisar,Haryana |
| Address |
Department of Anaesthesia,
Division-Operation Theatre Complex,
Room No-120,
Maharaja Agarsen Medical College,
Agroha,Hisar,Haryana
Hisar
HARYANA
125047
India |
| Phone |
9466088221 |
| Fax |
|
| Email |
drvibhamehta1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maharaja Agarsen Medical College,
Agroha,Hisar,Haryana |
|
|
Primary Sponsor
|
| Name |
Dr Rajat Kathpal |
| Address |
Department of Anaesthesia,
Maharaja Agarsen Medical College,
Agroha,Hisar,Haryana |
| Type of Sponsor |
Other [Self] |
|
|
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 Rajat Kathpal |
Maharaja Agarsen Medical College |
Department of Anaesthesia,
Division-Operation Theatre Complex,
Room No-120,
Hisar
HARYANA |
9896683083
dr.rajatkathpal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE FOR HUMAN RESEARCH ,Maharaja Agrasen Medical College,Agroha,Hisar(Haryana) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 1||Obstetrics, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Not Epinephrine |
4 micrograms as intravenous bolus from administration of sub arachnoid block to end of surgery, if required. |
| Comparator Agent |
Phenylepherine |
50 micrograms as intravenous bolus from administration of sub arachnoid block to end of surgery, if required. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Those parturients who will develop hypotension after subarachnoid block, with systolic blood pressure being <20% of the baseline value will be included in the study. |
|
| ExclusionCriteria |
| Details |
Parturients with:-
1.Fetal Abnormality.
2.Preexisting or Pregnancy Induced Hypertension.
3.Known Cardiovascular or Cerebrovascular Disease.
4.Thrombocytopenia.
5.Coagulopathy or any medical contraindication to spinal anesthesia.
6.Weight <50 kg or >100kg.
7.Height <140 cm or >180 cm.
8.Parturient using monoamine oxidase inhibitors or tricyclic anti-depressants.
9.Parturient allergic to study drug.
10.Refusal of informed consent.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Haemodynamic Changes:
Blood pressure & HR will be monitored every 2 mins till 10 min, & thereafter every 5 min till the end of surgery.
Incidence of hypotension, bradycardia, tachycardia, hypertension will be noted.
2.No. of boluses of vasopressor agents given intraoperatively will be noted.
|
From administration of sub arachnoid block to end of surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Fetal Outcome:
A paediatrician who will not be aware of the vasopressor used will note:
a) APGAR SCORE:- at 1 min & 5 mins.
b) Fetal Acidosis:- Umbilical arterial sample will be collected at the time of birth to analyse pH. Fetal acidosis will be defined as pH less than 7.
2.Complications if any:
Incidence of dizziness, nausea, vomiting or shivering due to maternal hypotension will also be noted.
|
From administration of sub arachnoid block to end of surgery. |
|
|
Target Sample Size
|
Total Sample Size="210"
Sample Size from India="210"
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 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
This study will be conducted in a prospective, randomized, double blinded and comparative manner in the Department of Anaesthesiology and Critical Care, Maharaja Agarsen Medical college, Agroha.The primary objective of the study will be to determine whether nor epinephrine is more effective compared to phenylephrine for treatment of maternal hypotension undergoing emergency lower segment cesarean section under subarachnoid block.The secondary objectives will be to determine effect of nor epinephrine and phenylephrine bolus on maternal heart rate and on fetal outcome by assessing APGAR score and investigating fetal acidosis. |