CTRI Number |
CTRI/2023/08/056943 [Registered on: 25/08/2023] Trial Registered Prospectively |
Last Modified On: |
24/08/2023 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
Public Title of Study
|
Norepinephrine infusion for controlling spinal anaesthesia induced hypotension in caesarian section. |
Scientific Title of Study
|
Effect of different doses of norepinephrine infusion for controlling spinal anaesthesia induced hypotension in caesarean section- a randomized controlled 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 |
ANISH M |
Designation |
Post Graduate Trainee |
Affiliation |
Regional Institute of Medical Sciences , Imphal |
Address |
Department of Anaesthesiology, Regional Institute of Medical Sciences
Imphal West MANIPUR 795004 India |
Phone |
8547116936 |
Fax |
|
Email |
anishmohan07193@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr T Hemjit Singh |
Designation |
Assistant Professor |
Affiliation |
Regional Institute of Medical Sciences , Imphal |
Address |
Department of Anaesthesiology, Regional Institute of Medical Sciences
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 , Imphal |
Address |
Department of Anaesthesiology, Regional Institute of Medical Sciences
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 |
|
Primary Sponsor
|
Name |
Anish M |
Address |
Regional Institute of Medical Sciences, Imphal, Manipur |
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 Anish M |
Regional Institute of Medical Sciences |
Operation Theatre complex (OT 1-8),Department of Anaesthesiology, Regional Institute of Medical Sciences Imphal West MANIPUR |
8547116936
anishmohan07193@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, Manipur |
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 |
Comparator Agent |
1 ml/kg/hr of Normal saline |
Study participants will be randomized into 4 groups. Comparator group recieving 1 ml/kg/hr of intravenous Normal saline infusion after giving spinal anaesthesia till the completion of surgery |
Intervention |
Administration of intravenous infusion of 5 micrograms/kg/hr or 8 micrograms/kg/hr or10 micrograms/kg/hr of Norepinephrine |
Study participants will be randomized into 4 groups. Intervention groups recieving either intravenous infusion of 5 micrograms/kg/hr or 8 micrograms/kg/hr or10 micrograms/kg/hr of norepinephrine after giving spinal anaesthesia till the completion of surgery |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
50.00 Year(s) |
Gender |
Female |
Details |
1.Patients of age group 18 to 50 years undergoing elective caesarean section
2.Patients with ASA physical grade I or II
|
|
ExclusionCriteria |
Details |
1. History of allergy to local anaesthetic agent and/ or study drugs
2. Bleeding disorders like Von Willebrand disease, ITP, platelet count <50.000/microlitre, prothrombin time> 14 seconds, International normalised ratio (INR) > 1.5
3. Local site infection
4. Spinal deformity
5. Cardiac, respiratory diseases and kidney disorder, neurological deficit
6. Parturients with PET or any hypertensive disorder.
|
|
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 |
Occurrence of hypotension |
Outcome will be continuously recorded every 2 mins till 10 mins then every 5 mins until the end of surgery & data will be asessed at the end of 1 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 & then every 5 mins until the end of surgery |
|
Target Sample Size
|
Total Sample Size="120" Sample Size from India="120"
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)
|
04/09/2023 |
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 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 common preferred type of anaesthesia in elective caesarean section. But hypotension following spinal anaesthesia is a common and dreadful complication. Use of non pharmacological methods are not found to be effective, hence use of vasopressor is indicated in management of hypotension. Among vasopressors norepinephrine is a drug which manages hypotension as well as maintains the hemodynamic parameters of the parturient. Here, in our study we would find out the optimal dosage of norepinephrine infusion for management of spinal hypotension by recording the incidence of hypotension after different regimens of norepinephrine infusion. We will also try to find which regimen provides better hemodynamic stability and fetal outcome with least adverse reactions. A total of 120 parturient, aged 18 to 50 years belonging to American society of Anaesthesiologists (ASA) I and II, undergoing lower segment caesarean section under spinal anaesthesia will be divided into four groups (Group A, Group B, Group C and Group D) by block randomization. Group A patients will receive norepinephrine 5 μg/kg/h as intravenous infusion, group B patients will receive norepinephrine 8 μg/kg/h as intravenous infusion, group C patients will receive norepinephrine 10 μg/kg/h as intravenous infusion and group D will receive normal saline as intravenous infusion after sub arachnoid block at the rate of 1ml/kg/hr. The number of occurence 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 the four groups. The incidence of bradycardia, hypertension and foetal outcome 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 analysed and inference will be drawn. |