| CTRI Number |
CTRI/2024/06/069374 [Registered on: 24/06/2024] Trial Registered Prospectively |
| Last Modified On: |
16/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A randomized double blind controlled study to evaluate Effect of low dose intravenous ketamine on hemodynamic characteristics in parturients undergoing caesarean delivery under spinal anaesthesia,our outcomes will be to evaluate incidence of post spinal hypotension. |
|
Scientific Title of Study
|
Effect of low dose intravenous ketamine on hemodynamic characteristics in parturients undergoing caesarean delivery under spinal anaesthesia |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Himanshu singh |
| Designation |
Post graduate student |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room no 315 third floor Department of Anesthesiology and intensive care,Maulana Azad Medical College and BL Taneja Block, New Delhi 110002
Room no 315 third floor Department of Anesthesiology and intensive care, Maulana Azad Medical College and BL Taneja Block, New Delhi 110002
Central
DELHI
110002
India |
| Phone |
7987720614 |
| Fax |
|
| Email |
hs8879953@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sonia Wadhawan |
| Designation |
Director professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room no 312 third floor Department of Anesthesiology and intensive care,Maulana Azad Medical College,New Delhi 110002
Room no 312 third floor department of Anesthesiology and intensive care, Maulana Azad Medical College New Delhi, 110002
Central
DELHI
110002
India |
| Phone |
9810946845 |
| Fax |
|
| Email |
soniawadhawan@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Himanshu singh |
| Designation |
Post graduate student |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room no 315 third floor Department of Anesthesiology and intensive care,Maulana Azad Medical College and BL Taneja Block,New Delhi 110002
Room no 315 third floor department of Anesthesiology and intensive care, Maulana Azad Medical College and BL Taneja Block, 110002
Central
DELHI
110002
India |
| Phone |
7987720614 |
| Fax |
|
| Email |
hs8879953@gmail.com |
|
|
Source of Monetary or Material Support
|
| Lok Nayak Hospital
Jawaharlal Nehru Marg, near Delhi Gate New Delhi 110002 |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College |
| Address |
Maulana Azad Medical College 2 bahadur Shah Jafar marg, New Delhi 110002 |
| Type of Sponsor |
Government 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 Himanshu Singh |
Lok Nayak Hospital |
Obstetrics and Gynaecology OT
Department of anaesthesiology and critical care New Delhi
Central
DELHI |
7987720614
hs8879953@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee Maulana Azad Medical College New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Group CT (control group) |
Parturients in this group will receive 10 ml of normal saline bolus followed by an infusion of 0.1 ml/kg/hr |
| Intervention |
Group KT (ketamine) |
parturients in this group will recieve 0.3 mg/kg kwtamine iv diluted to 10 ml with normal saline followed by an infusion of o.1 mg/kg/hr |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
18-40 years
American society of anesthesiology (ASA) physical status 2 and 3
Singleton pregnancy
Period of gestation atleast 37 weeks
Scheduled to undergo caesarean section via pfannenstiel incision |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of hypotension (systolic blood pressure less than 80% of base line) in parturients undergoing caesarean delivery under spinal anesthesia |
2 minute interval for 1st 15 minutes thereafter every 5 minutes till the end of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Severity of alteration in hemodynamic parameters intraoperative
2.Incidence of intraoperative shivering
3. Neonatal outcome by cord blood pH
4. Postoperative analgesia |
intra operatively
24 hours in postoperative period |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
01/07/2024 |
| 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 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
|
Aim of the study is to assess the effect of low dose intravenous ketamine on hemodynamic characteristics in parturients undergoing caesarean delivery under spinal anesthesia. It is a randamized double blind controlled study taking a total sample of 70, 35 parturients in each group. |