| CTRI Number |
CTRI/2024/01/061947 [Registered on: 29/01/2024] Trial Registered Prospectively |
| Last Modified On: |
26/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective observational study |
| Study Design |
Other |
|
Public Title of Study
|
Propofol a sedative and anaesthetic drug given as a continuous intravenous form. For administration of this drug two types of pump will be used. A normal manually controlled pump and target controlled pump with a computer program . |
|
Scientific Title of Study
|
A Prospective observational research comparing the recovery profiles of patients undergoing non-abdominal procedures who received propofol using Schneider(TIVA) pharmacokinetics model versus manual infusion. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Keerthana M |
| Designation |
Post graduate |
| Affiliation |
saveetha medical college and hospital. |
| Address |
Saveetha Medical College and Hospital,
Saveetha Nagar , Thandalam ,
Chennai.
Chennai
TAMIL NADU
602105
India |
| Phone |
9489565346 |
| Fax |
|
| Email |
keerthena@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR.Pradeep.K |
| Designation |
Professor |
| Affiliation |
saveetha medical college and hospital |
| Address |
Saveetha Medical College and Hospital,
Saveetha Nagar , Thandalam ,
Chennai.
TAMIL NADU
602105
India |
| Phone |
9489565346 |
| Fax |
|
| Email |
drkpradeep@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Keerthana M |
| Designation |
Post graduate |
| Affiliation |
saveetha medical college and hospital |
| Address |
Saveetha Medical College and Hospital,
Saveetha Nagar , Thandalam ,
Chennai.
TAMIL NADU
602105
India |
| Phone |
9489565346 |
| Fax |
|
| Email |
keerthena@gmail.com |
|
|
Source of Monetary or Material Support
|
| Saveetha Medical College and Hospital.
saveetha nagar , Thandalam ,
Chennai-602105 |
|
|
Primary Sponsor
|
| Name |
Keerthana M |
| Address |
Saveetha Medical college and Hospital,
Saveetha Nagar, Thandalam. |
| 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 |
| Keerthana M |
Saveetha Medical College and Hospital |
Department of Anaesthesiology,
Saveetha Nagar , Thandalam,
Chennai.
Chennai
TAMIL NADU |
9489565346
keerthena@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha medical College and Hospital Institutional Ethics Committee. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
American society of anaesthesiologist physical status I and II.
Patients undergoing non-abdominal surgeries. |
|
| ExclusionCriteria |
| Details |
Age below 18 years and above 60 years.
ASA III and above. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Induction time at start of surgery.
extubation time at end of surgery. |
Induction time at start of surgery.
extubation time at end of surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| modified Aldrete score for recovery - end of surgery. |
modified aldrete score for recovery - end of surgery |
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
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)
|
09/02/2024 |
| 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="0"
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
|
Patients will be shifted inside the operating room and baseline monitors such as ECG , Bloodpressure ,pulse oximeter shall be connected and baseline parameters will be noted . A 18g Intravenous cannula will be placed . General anesthesia will be induced and maintained by either manual syringe pump or target- controlled pump using propofol . Depth of anesthesia shall be monitored using bispectral index monitor (BIS). Depending upon the BIS value , the dose of propofol will be adjusted. At the end of surgery patient’s recovery will be noted with modified Aldrete score. |