| CTRI Number |
CTRI/2024/10/075003 [Registered on: 09/10/2024] Trial Registered Prospectively |
| Last Modified On: |
27/09/2024 |
| 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
|
norepinephrine and phenylephrine infusion for controlling spinal anaesthesia induced hypotension in caesarean section |
|
Scientific Title of Study
|
a comparative study of prophylactic norepinephrine and phenylephrine infusion for controlling spinal anaesthesia induced hypotension in parturients undergoing lower section caesarean section-randomized clinical trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| A/206/REB-Comm(SP)/RIMS/2015/970/01/2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Joydeepa Das |
| Designation |
Post graduate trainee |
| Affiliation |
Regional Institute of Medical Sciences |
| Address |
Department of Anaesthesiology, Regional Institute of Medical Sciences, Imphal West, Manipur
Imphal West
MANIPUR
795004
India |
| Phone |
9485161543 |
| Fax |
|
| Email |
Joydeepadas36@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr T Hemjit Singh |
| Designation |
Assistant Professor |
| Affiliation |
Regional Institute of Medical Sciences |
| Address |
Department of Anaesthesiology, Regional Institute of Medical Sciences, Imphal West, Manipur
Imphal West
MANIPUR
795004
India |
| Phone |
9436021445 |
| Fax |
|
| Email |
takhelhem@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr T Hemjit Singh |
| Designation |
Assistant Professor |
| Affiliation |
Regional Institute of Medical Sciences |
| Address |
Department of Anaesthesiology, Regional Institute of Medical Sciences, Imphal West, Manipur
Imphal West
MANIPUR
795004
India |
| Phone |
9436021445 |
| Fax |
|
| Email |
takhelhem@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, Regional Institute of Medical sciences, Imphal, Manipur, India, PIN- 795004 |
|
|
Primary Sponsor
|
| Name |
Joydeepa Das |
| Address |
Regional Institute of Medical Sciences, Imphal , Manipur, India, Pin- 795004 |
| 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 Joydeepa Das |
Regional Institute of Medical Sciences |
Operation Theatre complex (Ot 1-8), Department of Anaesthesiology, Regional Institute of Medical Sciences, Imphal,Manipur, India, 795004
Imphal West
MANIPUR |
9485161543
Joydeepadas36@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research Ethics Board, Regional Institute of Medical Sciences, Imphal |
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 |
administration of intravenous infusion of 150 mcg/hr of norepinephrine |
Study participants will be randomized into 2 groups. One intervention group receiving an intravenous infusion of norepinephrine 150mcg/hr after giving spinal anesthesia till completion of surgery and 1ml of the same drug as an intravenous bolus dose whenever blood pressure falls below 20% of baseline |
| Intervention |
administration of intravenous infusion of 3mg/hour of phenylephrine |
study participants will be randomized into 2 groups. One group will receive an intravenous infusion of 3mg/hour of phenylephrine after giving spinal anesthesia till completion of surgery and 1ml of the same drug as intravenous bolus whenever blood pressure falls below 20% of baseline. |
| Comparator Agent |
not applicable |
not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Patients of age group 18 to 45 years undergoing elective caesarean section
Patients with American Society of Anaesthesiologists (ASA) physical grade I or II |
|
| ExclusionCriteria |
| Details |
history of allergy to local anesthetic drug and study drugs
local site infection
spinal deformity
parturients with PET or any hypertensive disorder
bleeding disorders
cardiac, respiratory diseases, kidney disorders, neurological deficit |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| occurence of hypotension |
outcome will be continuosly recorded every 2 mins till 10mins then every 5 mins until the end of surgery and data will be assessed at the end of one year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Apgar score, umbilical vein blood gases record, hemodynamic changes, norepinephrine consumption, adverse effects |
all outcomes will be continuously recorded every 2 mins till 10 mins and then every 5 mins until the end of surgery |
|
|
Target Sample Size
|
Total Sample Size="104"
Sample Size from India="104"
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 3 |
|
Date of First Enrollment (India)
|
09/10/2024 |
| 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)
|
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 most commonly preferred type of anaesthesia in elective cesarean section. But hypotension following spinal anaesthesia is a common and dreadful complication. The use of nonpharmacological methods is not found to be effective, hence use of vasopressor is indicated in the management of hypotension. Among vasopressors norepinephrine and phenylephrine are used. Here, in our study, we will compare the infusion doses of two drugs to prevent spinal anesthesia-induced hypotension. We will also try to find out the vasopressor (phenylephrine or norepinephrine) that brings the most stable hemodynamic response and least adverse reactions. A total of 104 parturients, aged 18 to 45 years belonging to the American Society of Anaesthesiologists (ASA) I and II, undergoing lower segment caesarean section under spinal anaesthesia will be divided into two groups (Group A and Group B) by block randomization. Group A patients will receive norepinephrine 60ml/hr as intravenous infusion, group B patients will receive phenylephrine 60ml/hr as intravenous infusion, after subarachnoid block at the rate of 1ml/kg/hr. The number of occurrences of hypotension (before delivery and after delivery) will be noted. Hemodynamic parameters will be monitored and recorded. The baseline values will be compared with the values obtained after spinal block in all four groups. The incidence of bradycardia, hypertension, and fetal outcomes such as Apgar score and umbilical vein blood gases will also be recorded. The findings and observations made during the entire study will be tabulated, graphically depicted whenever possible, statistically analyzed and inference will be drawn. |