| CTRI Number |
CTRI/2025/09/094819 [Registered on: 15/09/2025] Trial Registered Prospectively |
| Last Modified On: |
12/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Incidence of Hypotension in participants on exposure to varying doses of propofol- A Randomized conrol trial. |
|
Scientific Title of Study
|
Incidence of Post Induction Hypotension with varying doses of propofol- A Randomized conrol 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 H S MURTHY |
| Designation |
Head of the Department. |
| Affiliation |
Manipal Hospitals, OLd airport road Bangalore. |
| Address |
Department of Anesthesia,
Manipal Hospitals, Old airport Road, Kodihalli, Bangalore.
Bangalore
KARNATAKA
560017
India |
| Phone |
9945469997 |
| Fax |
|
| Email |
drhsmurthy@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr H S MURTHY |
| Designation |
Head of the Department. |
| Affiliation |
Manipal Hospitals, OLd airport road Bangalore. |
| Address |
Department of Anesthesia,
Manipal Hospitals, Old airport Road, Kodihalli, Bangalore
Bangalore
KARNATAKA
560017
India |
| Phone |
9945469997 |
| Fax |
|
| Email |
drhsmurthy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr H S MURTHY |
| Designation |
Head of the Department. |
| Affiliation |
Manipal Hospitals, OLd airport road Bangalore. |
| Address |
Department of Anesthesia,
Manipal Hospitals, Old airport Road, Kodihalli, Bangalore.
Bangalore
KARNATAKA
560017
India |
| Phone |
9945469997 |
| Fax |
|
| Email |
drhsmurthy@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesia, Manipal Hospitals, Old airport Road, Kodihalli, Bangalore, Karnataka, India.
560017 |
|
|
Primary Sponsor
|
| Name |
Manipal Hospitals |
| Address |
Department of Anesthesia, Manipal Hospitals, Old airport Road, Kodihalli, Bangalore, Karnataka, India.
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 Tejaswini |
Manipal Hospitals, Old airport Road. Bangalore. |
Departement of Anaesthesia.
Manipal hospitals. Old airport Road. Kodihalli. Bangalore.
Bangalore
KARNATAKA |
8747954969
utej96@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 anaesthesia with 1.5mg per kg body weight of propofol |
In patients undergoing general anesthesia with endotracheal tube placement, the induction is done with 1.5mg per kg body weight of propofol.
Duration of intervention- induction of general anesthesia. 30 seconds - 1 minute |
| Comparator Agent |
Induction of anaesthesia with 2mg per kg body weight of propofol. |
In patients undergoing general anesthesia with endotracheal tube placement, the induction is done with 2mg per kg body weight of propofol
Duration of intervention- Induction of general anesthesia- 30seconds- 1 minute |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA I/II patients
2. Patients between the ages of 18 years and 49 years of any gender.
3. Patiets undergoing genral ananesthesia with endotracheal tube placement. |
|
| ExclusionCriteria |
| Details |
1. Patient refusal to participate in the study
2. Patient allergic to propofol
3. ASA III/IV grading of patients
4. Patients undergoing surgeries which do not need general anaesthesia or placement of endotracheal tube. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the hemodynamic changes post induction with different doses of propofol by studying the vital signs in 2 groups for 10 minutes post induction. |
To evaluate the hemodynamic changes post induction with different doses of propofol by studying the vital signs 2 groups for 10 minutes post induction. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To asses the Induction quality score for 2 doses of propofol
2. To assess Ramsay sedation score at extubation.
3. To assess Aldrete score prior to discharge from PACU. |
Induction to 30 minutes 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)
|
01/10/2025 |
| 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 rondomized control study to assess the incidence of post indution hypotension in patient underfoing general anyesthesia needing an endotracheal tube placement with 2 doses of propofol. The HR, SBP, DBP, MAP will be assessed from 3 minutes before induction to 10 minutes after intubation, along with the airway assessment and scopy duration. The need for pressor treatment will be documented. The intubation quality score, Ramsay sedation score and aldrete score will be assess at intubation, extubation and discharge from PACU respectively. Sample size of 84 in each group- Total of 168. The duration of study is 6 months. |