| CTRI Number |
CTRI/2025/10/096412 [Registered on: 23/10/2025] Trial Registered Prospectively |
| Last Modified On: |
22/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
How Different Doses of Propofol Affect Blood Pressure After Induction in Elderly Patients |
|
Scientific Title of Study
|
Association of
propofol induction dose and post induction hypotension with varying doses of propofol
in elderly in non cardiac surgery a randomised control trial |
| 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 HS MURTHY |
| Designation |
HEAD OF THE DEPARTMENT |
| Affiliation |
Manipal Hospital,Old Airport Road |
| Address |
Manipal Hospital,old airport road, 98, HAL Old Airport Rd, Kodihalli, Bengaluru, Karnataka 560017
Bangalore
KARNATAKA
560017
India |
| Phone |
9945469997 |
| Fax |
|
| Email |
drhsmurthy@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR HS MURTHY |
| Designation |
HEAD OF THE DEPARTMENT |
| Affiliation |
Manipal Hospital,Old Airport Road |
| Address |
Manipal Hospital,old airport road, 98, HAL Old Airport Rd, Kodihalli, Bengaluru, Karnataka 560017
Bangalore
KARNATAKA
560017
India |
| Phone |
9945469997 |
| Fax |
|
| Email |
drhsmurthy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR HS MURTHY |
| Designation |
HEAD OF THE DEPARTMENT |
| Affiliation |
Manipal Hospital,Old Airport Road |
| Address |
Manipal Hospital,old airport road, 98, HAL Old Airport Rd, Kodihalli, Bengaluru, Karnataka 560017
Bangalore
KARNATAKA
560017
India |
| Phone |
9945469997 |
| Fax |
|
| Email |
drhsmurthy@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaethesia
HAL Old Airport Road, Kodihalli, Bengaluru, Karnataka: 560017 |
|
|
Primary Sponsor
|
| Name |
Manipal Hospitals |
| Address |
98, HAL Old Airport Road, Kodihalli, Bengaluru, Karnataka 560017 |
| 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 |
| DR ANJALA |
Manipal Hospital, Old Airport Road |
DEPARTMENT OF ANAESTHESIA
98, HAL Old Airport Road, Kodihalli, Bengaluru, Karnataka 560017
Bangalore
KARNATAKA |
7034617246
anjala.basheerc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE OF MANIPAL HOSPITALS,BANGALORE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R098||Other specified symptoms and signsinvolving the circulatory and respiratory systems, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Induction of anesthesia with 1 mg/kg body weight of propofol |
In patients undergoing general anaesthesia with endotracheal tube placement, induction will be done with 1 mg/kg body weight of propofol.
Duration of intervention- induction time: 30 sec-1 min
|
| Comparator Agent |
Induction of anesthesia with 1.5 mg/kg body weight of propofol |
In patients undergoing general anaesthesia with endotracheal tube placement, induction will be done with 1.5 mg/kg body weight of propofol.
Duration of intervention- induction time: 30 sec-1 min |
|
|
Inclusion Criteria
|
| Age From |
65.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
ASA I/II/III PATIENT
AGE MORE THAN OR EQUAL TO 65 YEARS OF ANY GENDER
PATIENTS UNDERGOING GA WITH ET TUBE PLACEMENT |
|
| ExclusionCriteria |
| Details |
Patient refusal to participate in the study.
Patient allergic to propofol.
ASA IV grading of patients.
Patients undergoing surgeries which do not need general anaesthesia or placement of endotracheal tube.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the hemodynamic changes post induction in both doses of propofol by studying the vital signs in 2 groups for 11 mins post induction |
To evaluate the hemodynamic changes post induction in both doses of propofol by studying the vital signs in 2 groups for 11 mins post induction |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 to asses induction quality score for 2 dses of propofol
2. to asses Ramsy Sedation scale at extubation
3.to asses adrele score prior to discharge from PACY |
Induction to 30 mins after extubation |
|
|
Target Sample Size
|
Total Sample Size="168"
Sample Size from India="168"
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)
|
15/11/2025 |
| 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="6"
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
|
A randomized controlmstudy to asses the incidence of post induction hypotension in patientundergoing general anatgesia with ET tube placement with 2 doses of propofol and to asses the viral(HR,SBP,DBP, MAP) will bd assejsd from 3 minutes before induction to 10 minitues after intubation along with airway assesment and duration of laryngoscopy. The need for pressor treatment will be documented The intubation quality score,alderete score and Ramsay sedation score will be asseseed at intubation and discharge from PACU respectively |