| CTRI Number |
CTRI/2024/07/069891 [Registered on: 04/07/2024] Trial Registered Prospectively |
| Last Modified On: |
03/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Out of iv Ketamine and iv Tramadol which one is better for prevention of shivering in patients undergoing caesarean section under spinal anaesthesia. |
|
Scientific Title of Study
|
Comparative study to evaluate efficacy of intravenous Ketamine and Tramadol for prevention of shivering in patients undergoing caesarean section 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 |
Dr Sudha Puhal |
| Designation |
Associate Professor |
| Affiliation |
Pt.B.D.Sharma PGIMS Rohtak |
| Address |
Department of Anaesthesiology and Critical Care, Pt.B.D.Sharma
PGIMS,Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9812570553 |
| Fax |
|
| Email |
sudhapuhal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Harsha Bhatia |
| Designation |
Junior Resident |
| Affiliation |
Pt.B.D.Sharma PGIMS Rohtak |
| Address |
Department of Anaesthesiology and Critical Care, Pt.B.D.Sharma
PGIMS,Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9354260473 |
| Fax |
|
| Email |
harshabhatia281@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Harsha Bhatia |
| Designation |
Junior Resident |
| Affiliation |
Pt.B.D.Sharma PGIMS Rohtak |
| Address |
Department of Anaesthesiology and Critical Care, Pt.B.D.Sharma
PGIMS,Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9354260473 |
| Fax |
|
| Email |
harshabhatia281@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology and Critical Care, Modular OT Complex, 3rd floor , PGIMS Rohtak , Haryana
124001
India |
|
|
Primary Sponsor
|
| Name |
Pt B D Sharma University of Health Sciences PGIMSRohtakHaryana |
| Address |
Pt.B.D.Sharma University of health Sciences PGIMS,Rohtak,Haryana
124001
India
|
| 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 Harsha Bhatia |
Pt.B.D.Sharma,PGIMS |
Department of Anaesthesiology and Critical Care
Rohtak
HARYANA |
9354260473
harshabhatia281@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical Research Ethics Committee Pt. B.D.Sharma PGIMS Rohtak |
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 |
| Comparator Agent |
Ketamine |
0.25 mg/kg ketamine in 10 ml normal saline,intravenous route,over 10 minutes after delivery of baby.
0.5 mg/kg ketamine in 10 ml normal saline, intravenous route,over 10 minutes after delivery of baby |
| Intervention |
Tramadol |
0.5 mg/kg in 10 ml normal saline,intravenous route,over 10 minutes after delivery of baby |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
120 Healthy pregnant women aged 18-40 years, American Society of Anesthesiologists (ASA) physical status II, with fullterm singleton pregnany requiring caesarean section under spinal anaesthesia. |
|
| ExclusionCriteria |
| Details |
Patients Refuse to give consent,Any contraindications and hypersensitivity to the study drugs,History of cardiovascular diseases, hypertension, Pregnancy Induced hypertension (PIH),Eclampsia, Antepartum hemorrhage, intake of antipsychotic medications,Patients who will develop shivering prior to administration of study drugs,Failure of spinal anaesthesia and patients requiring general anaesthesia or sedation or any other major intraoperative complications.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Prevention of shivering |
Intraoperatively every 5 minutes and post operatively every 10 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To prevent perioperative complications if any like nausea,vomiting,sedation,hypotension,bradycardia |
Intraoperatively every 5 minutes and postoperatively every 10 minutes |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
15/07/2024 |
| 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="3"
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
|
A prospective , Randomized and double blinded study will be conducted in healthy pregnant women,of 18 - 40 years of age without any comorbid conditions requiring caesarean section under spinal anaesthesia. Patient with refusal to consent, Patients with history of hypersensitivity to study drugs ,history of cardiovascular diseases, hypertension , pregnancy induced hypertension(PIH),Eclampsia, Antepartum Hemorrhage, intake of any antipsychotic medications. Patients who will develop shivering prior to study drugs. Failure of spinal anaesthesia and patient requiring general anaesthesia or sedation or and any other major intraoperative complications .will be excluded from study. Patient will be randomly allocated into one of the three groups ,according to computer generated list Group (K1)will receive 0.25mg/kg Ketamine, Group (K2) will receive 0.5mg/kg Ketamine, Group (T) will receive 0.5 mg/kg Tramadol. Patients will be prepared and given spinal anaesthesia and after delivery of baby the study drugs will be given. Patients heart rate ,blood pressure, oxygen saturation ,temperature, sedation score and shivering grading will be recorded, every 5 minutes intraoperatively and every 10 minutes postoperatively over an hour .Data will be analysed using appropriate statistical methods. |