| CTRI Number |
CTRI/2021/10/037203 [Registered on: 08/10/2021] Trial Registered Prospectively |
| Last Modified On: |
04/10/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative Evaluation of combination of Propofol with Ketamine or Propofol with Fentanyl in Day Care Surgeries |
|
Scientific Title of Study
|
Comparative Evaluation of combination of Propofol with Ketamine or Propofol with Fentanyl As Total Intravenous Anaesthesia Techniques In Day Care Surgeries of Short Duration- A Randomised Control Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pooja Kotak |
| Designation |
Pg student |
| Affiliation |
Mahatma Gandhi Institute of Medical Sciences, Sewagram |
| Address |
J.N girls hostel,j block ,room no. 1, department of anaesthesia, MGIMS, SEWAGRAM
Wardha
MAHARASHTRA
442102
India |
| Phone |
8530677383 |
| Fax |
|
| Email |
dr.poojakotak23@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sudha Jain |
| Designation |
Professor |
| Affiliation |
Mahatma Gandhi Institute of Medical Sciences, Sewagram |
| Address |
MGIMS, DEPARTMENT OF ANAESTHESIA,SEWAGRAM
Wardha
MAHARASHTRA
442102
India |
| Phone |
9850361863 |
| Fax |
|
| Email |
sudhajain@mgims.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pooja Kotak |
| Designation |
Pg student |
| Affiliation |
Mahatma Gandhi Institute of Medical Sciences, Sewagram |
| Address |
J.N girls hostel,j block ,room no. 1, department of anaesthesia, MGIMS, SEWAGRAM
Wardha
MAHARASHTRA
442102
India |
| Phone |
8530677383 |
| Fax |
|
| Email |
dr.poojakotak23@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Institute of medical sciences,department of anaesthesia Sewagram |
|
|
Primary Sponsor
|
| Name |
Mahatma Gandhi Institute of Medical Sciences |
| Address |
Mahatma Gandhi Institute of medical sciences, Sewagram |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| DrPooja Kotak |
Mahatma Gandhi Institute of medical sciences |
Mahatma Gandhi Institute of medical sciences,department of anaesthesia, sevagram
Wardha
MAHARASHTRA |
8530677383
dr.poojakotak23@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MGIMS Institutional Ethics Committee |
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 |
| Intervention |
Inj GLYCOPYRROLATE
INJ Propofol
Inj ketamine |
Injection glycopyrrolate 0.004mg/kg I/V followed by Injection ketamine 0.5 mg/kg I/V. After 2 minutes IV propofol 1% will be given at the rate of 40mg/10 seconds till the end point of induction (i.e. loss of consciousness and loss of eye lash reflex) . Top up doses (25 mg) of propofol will be given when the patient became light as evidenced by change in HR, B.P, lacrimation and limb movements. |
| Comparator Agent |
Inj GLYCOPYRROLATE
Inj propofol
Inj fentanyl |
Patients will be given Injection glycopyrrolate 0.004mg/kg I/V followed by Injection fentanyl 1.5 microgram/kg I/V. After 2 minutes I/V propofol 1% at the rate of 40mg/10 seconds will be given till the end point of induction. Top up doses (25 mg) of propofol will be given when the patient became light as evidenced by change in HR, B.P, lacrimation and limb movements. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1).Patient of either sex, aged between 18-65 yrs.
2) .Patient belonging to American ASA grade I&II.
3)Short surgical procedures duration of < 1 hour
4)Patient fit for home discharge on same day as day care procedure.
|
|
| ExclusionCriteria |
| Details |
1)Patient with systemic co morbidities like cardiovascular disease,hepatic disases, renal diseases,chronicobstructive lung diseases, etc
2)Allergy or contraindication to drugs used in study.
3)Morbid obesity (BMI> 40%)
4) Epilepsy patients
.5) Patients taking any antipsychotic medication.
.6)Pregnant ladies and lactating mothers.
7)Patient not giving consent to be part of study.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to compare the hemodynamic variables between the combination of propofol fentanyl and propofol ketamine |
18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the sedation score,side effect, recovery score, discharge criteria of two TIVA techniques ie propofol ketamine and propofol fentanyl combination |
18 months |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
11/10/2021 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is the randomised control trial to compare the hemodynamic variables , side effects,sedation score, recovery score and discharge criteria between the two combinations i.e propofol fentanyl and propofol ketamine as total intravenous anaesthesia in the short surgical procedure lasting for less than 60 minutes. For this trial , using double blinding and randomisation technique 2 groups (each of sample size 40 ) will be tested. |