| CTRI Number |
CTRI/2023/11/059859 [Registered on: 15/11/2023] Trial Registered Prospectively |
| Last Modified On: |
09/11/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Infusion norepinephrine versus infusion phenylephrine for prevention of hypotension after spinal anaesthesia in elective cesarean section.
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Scientific Title of Study
|
Norepinephrine versus phenylephrine infusion for prevention of hypotension after spinal anaesthesia in elective cesarean section-A randomised double blinded study.
|
| Trial Acronym |
Nil |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
CHILLARA MEENA |
| Designation |
JUINOR RESIDENT |
| Affiliation |
JSS ACADEMY OF HIGHER EDUCATION AND RESEARCH |
| Address |
Department of anaesthesiology, JSS hospital, Mysore.
Mysore
KARNATAKA
570004
India |
| Phone |
9949813502 |
| Fax |
|
| Email |
meenakshi23.mia@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR CAPTAIN GURUDATT CL |
| Designation |
PROFESSOR |
| Affiliation |
JSS ACADEMY OF HIGHER EDUCATION AND RESEARCH |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY,JSS HOSPITAL,MYSORE,KARNATAKA.
Mysore
KARNATAKA
570004
India |
| Phone |
9845312311 |
| Fax |
|
| Email |
dattguru55@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR CAPTAIN GURUDATT CL |
| Designation |
PROFESSOR |
| Affiliation |
JSS ACADEMY OF HIGHER EDUCATION AND RESEARCH |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY,JSS HOSPITAL,MYSORE,KARNATAKA.
Mysore
KARNATAKA
570004
India |
| Phone |
9845312311 |
| Fax |
|
| Email |
dattguru55@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
JSS ACADEMY OF HIGHER EDUCATION AND RESEARCH |
| Address |
JSS medical college and hospital, Mysore, 570004 |
| Type of Sponsor |
Private medical college |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr CHILLARA MEENA |
JSS MEDICAL COLLEGE AND HOSPITAL |
Department of obstetrics and gynecology, 2ND FLOOR,JSS HOSPITAL,MG road, agrahara, mysore
Mysore
KARNATAKA |
9949813502
meenakshi23.mia@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O759||Complication of labor and delivery, unspecified, (2) ICD-10 Condition: O||Medical and Surgical, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Inj. Norepinephrine |
After subarachnoid block with inj. bupivacaine 0.5%(H)2ml, inj. norepinephrine 8mcg/ml at the rate of 24ml/hr will be administered until the extraction of fetus |
| Comparator Agent |
Inj. phenylephrine |
After subarachnoid block with inj. bupivacaine 0.5%(H)2ml,inj.phenylephrine 100mcg/ml at the rate of 24ml/hr will be administered until the extraction of fetus. |
|
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Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
-Parturients of ASA-2 with no comorbidities.
-Height:150-170cm
-Undergoing elective cesarean under spinal anaesthesia |
|
| ExclusionCriteria |
| Details |
-BMI>30kg/m2
-Patients with cardiac comorbidities:
a. Rheumatic heart disease
b. Coronary artery disease
c. Hypertensive disorders of pregnancy.
-Allergic reaction to local anesthetics or any history of allergy to local anaesthetics. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
|
Participant and Investigator Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| To compare the changes in maternal heart and blood pressure following infusions of norepinephrine versus phenylephrine. |
Starts as soon as subarachnoid block is given and terminated on the delivery of the baby |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
.To study the of incidence of hypotension and bradycardia.
-To analyse the number of rescue doses of vasopressors used .
-To record the APGAR score of neonates at 1 minute and 5 minutes.
-To analyse the incidence of intra operative nausea and vomiting.
|
Starts as soon as subarachnoid block is given and terminated on the delivery of the baby |
|
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Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
24/11/2023 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
Following approval from the Institutional Ethical Committee, informed and written consent will be taken from 60 parturients of American Society of Anaesthesiologists Physical status (ASA) class II undergoing elective lower segment cesarean section under spinal anaesthesia.Randomization of parturients will be done by shuffled sealed opaque envelope technique. A thorough pre-anesthetic evaluation (PAE) will be done 24 hours prior to the elective cesarean section. Standard monitoring with electrocardiography (ECG), automated NIBP (noninvasive blood pressure), heart rate (HR) and pulse oximetry (SpO2) will be done and baseline values of SBP (systolic blood pressure), DBP (diastolic blood pressure), MAP (mean arterial pressure), HR, ECG and saturation will be recorded and monitored intra-operatively by GE B125M monitor. Group NE- 30 parturients will receive3.2 mcg/min of norepinephrine as iv infusion Group PE - 30 parturients will receive 40mcg/min of phenylephrine as IV infusion Under asepsis, a subarachnoid block will be performed in a sitting position using 25G Quincke spinal needle and injection bupivacaine 0.5%(Heavy) 2ml will be given intrathecally. Infusion of the study solution will be started as soon as subarachnoid block is given. A solution of either phenylephrine 100mcg/ml (group PE) or norepinephrine 8 mcg/ml (group NE) at a rate of 24ml/hr which has been prepared in 50ml syringes will be administered through a seperate intravenous line. The automated NIBP cycling time will be kept at 1 min interval after intrathecal injection until delivery of fetus.Any incidence of SBP less than or equal to 80% of baseline or an absolute value less than 100 mm hg will be treated with bolus of 1/2ml study drug in increments till the BP is normalized and the number of episodes will be noted and total number of increments will be noted .If there is any episode of hypertension defined as SBP greater than or equal to 120% then the study drug infusion will be stopped till the BP is < 120% and infusion is restarted and number of episodes of hypertension will be noted.If there is bradycardia which is defined as heart rate <60beats/min will be treated by giving intravenous injection atropine0.6mg. The study will be terminated on delivery of the baby and the study solution will be continued at the discretion of the attending anaesthesiologist till the end of surgery . Episodes of intraoperative nausea and vomiting will be recorded using the nausea vomiting score: 0: None;1:Reported nausea without vomiting;2:observed vomiting8 . Intra operative nausea and vomiting will be treated with injection of ondansetron 4mg I/v at a score greater than or equal to 1. Immediately after delivery,APGAR scores will be assessed and recorded at 1 min and 5 min .
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