| CTRI Number |
CTRI/2025/11/097947 [Registered on: 24/11/2025] Trial Registered Prospectively |
| Last Modified On: |
21/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Other (Specify) [Technique of administration of drug] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing Two methods of Propofol Administration techniques for Anesthesia induction and its effects on Induction Hemodynamics- Bolus Technique Versus Target Controlled infusion (TCI) |
|
Scientific Title of Study
|
Comparison of Hemodynamic and Intubation Responses to Propofol Induction using Schneider model TCI Versus Bolus Technique |
| 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 Department of Anaesthesia |
| Affiliation |
Manipal Hospital |
| Address |
Anesthesia department, Manipal Hospital,98, HAL Old Airport Road, Bangalore 560017
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 Department of Anaesthesia |
| Affiliation |
Manipal Hospital |
| Address |
Anesthesia department, Manipal Hospital,98, HAL Old Airport Road, Bangalore 560017
Bangalore
KARNATAKA
560017
India |
| Phone |
9945469997 |
| Fax |
|
| Email |
drhsmurthy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Poorani R |
| Designation |
DNB Resident |
| Affiliation |
Manipal Hospital |
| Address |
Anesthesia Department, Manipal Hospital,98, HAL Old Airport Road, Bangalore 560017
Bangalore
KARNATAKA
560017
India |
| Phone |
9488705777 |
| Fax |
|
| Email |
poorani8230@gmail.com |
|
|
Source of Monetary or Material Support
|
| Manipal Hospital,98, HAL Old Airport Road Bangalore 560017 |
|
|
Primary Sponsor
|
| Name |
Manipal Hospital |
| Address |
Manipal Hospital,98, HAL Old Airport Road Bangalore 560017 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Poorani |
Manipal Hospital |
Department of Anesthesia,
Manipal Hospital,98, HAL Old Airport Road, Kodihalli Bangalore 560017
Bangalore
KARNATAKA |
9488705777
poorani8230@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE OF MANIPAL HOSPITALS,BANGALORE-17 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Bolus technique |
Propofol 2mg per kg intravenous bolus |
| Intervention |
TARGET CONTROLLED INFUSION(TCI) |
Target effect site concentration will be set at 5mcg per ml using Schneider model. TCI will be continued till Endotracheal intubation the duration of which is likely to last 3 to 5 minutes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)ASA1 AND ASA2
2)Patients with BMI less than 35
3)Patients undergoing general anesthesia with endotracheal tube placement |
|
| ExclusionCriteria |
| Details |
1)Patient refusal to participate in study
2)Patient allergic to propofol
3)ASA III or IV
4)Patients undergoing surgeries which do not need general anesthesia or placement of endotracheal tube
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the incidence of postinduction hypotension with Target controlled infusion (TCI) and manual bolus induction of propofol |
1 minute before induction to 10 minutes postinduction (or before surgical incision whichever is earlier). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the hemodynamic changes (heart rate & blood pressure) during laryngoscopy & tracheal intubation between Target controlled infusion (TCI) & manual bolus induction of propofol |
1 minute before induction to 10 minutes after induction (or surgical incision, whichever is earlier) |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
05/12/2025 |
| 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="10"
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
|
This is study is a prospective, randomized, parallel
group, single-center trial comparing the hemodynamic and intubation responses
to propofol induction using Schneider model Target controlled
infusion (TCI) and propofol
IV. Adult patients between age of 18 to 60years undergoing elective surgery
under general anesthesia will be randomly allocated to one of the two induction
techniques using computer generated randomization. Hemodynamic
parameters like Heart rate (HR), Systolic blood pressure (SBP), Diastolic blood
pressure (DBP) and Mean-arterial pressure (MAP) will be measured 1 minute
before induction to 10 minutes after induction (or before surgical incision
whichever is earlier). A total sample size of 140
participants (70 in each group) will be enrolled. The primary outcome is to
evaluate the incidence of postinduction hypotension with TCI
and manual bolus induction with propofol and secondary outcome is to compare
the hemodynamic changes (heart rate and blood pressure) during laryngoscopy and
tracheal intubation between TCI and manual bolus induction with propofol. The
expected study duration is 10 months from the date of first patient enrolment.
|