CTRI

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CTRI Number

CTRI/2025/08/092237 [Registered on: 04/08/2025] Trial Registered Prospectively

Last Modified On:

04/08/2025

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug
Medical Device
Surgical/Anesthesia

Study Design

Randomized, Parallel Group Trial

Public Title of Study

A study comparing how well a mixture of ketamine and propofol works versus propofol alone for inducing anaesthesia prior to ENT surgery using brain activity monitoring called bispectral index monitoring.

Scientific Title of Study

Efficacy of Ketamine-Propofol versus Propofol on BIS defined induction of anaesthesia in ENT Surgeries- A randomized controlled 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 Medhavrat Nirala
Designation	Post Graduate Resident, Department of Anaesthesiology
Affiliation	Kalinga Institute of Medical Sciences, Bhubaneswar
Address	Kalinga Institute of Medical Sciences, Bhubaneswar Department of Anaesthesiology, Kalinga Institute of Medical Sciences, Bhubaneswar, Orissa- 751024 Khordha ORISSA 751024 India
Phone	8638012310
Fax
Email	medhavratn@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Amrita Panda
Designation	Professor and Head of the Department, Department of Anaesthesiology
Affiliation	Kalinga Institute of Medical Sciences, Bhubaneswar
Address	Kalinga Institute of Medical Sciences, Bhubaneswar Professor and Head of the Department, Department of Anaesthesiology, Kalinga Institute of Medical Sciences, Bhubaneswar, PIN-751024 Khordha ORISSA 751024 India
Phone	9439862335
Fax
Email	amrita.panda@kims.ac.in

Details of Contact Person
Public Query

Name	Dr Amrita Panda
Designation	Professor and Head of the Department, Department of Anaesthesiology
Affiliation	Kalinga Institute of Medical Sciences, Bhubaneswar
Address	Kalinga Institute of Medical Sciences, Bhubaneswar Professor and Head of the Department, Department of Anaesthesiology, Kalinga Institute of Medical Sciences, Bhubaneswar, PIN-751024 Khordha ORISSA 751024 India
Phone	9439862335
Fax
Email	amrita.panda@kims.ac.in

Source of Monetary or Material Support

Kalinga Institute of Medical Sciences,Bhubaneswar,Orissa,District Khorda, PIN 751024

Primary Sponsor

Name	Kalinga Institute of Medical Sciences, Bhubaneswar
Address	Kushabhadra Campus5, KIIT Road, Bhubaneswar, Odisha-751024
Type of Sponsor	Private medical college

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Medhavrat Nirala	Kalinga Institute of Medical Sciences, Bhubaneswar	Kalinga Institute of Medical Sciences, Kushabhadra Campus 5, KIIT Road, Bhubaneswar Khordha ORISSA	08638012310 medhavratn@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional Ethics Committee, Kalinga Institute of Medical Sciences ( KIMS), KIIT Deemed to be University, Bhubaneswar-751024	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type

Condition

Patients

(1) ICD-10 Condition: H720||Central perforation of tympanic membrane, (2) ICD-10 Condition: H721||Attic perforation of tympanic membrane, (3) ICD-10 Condition: H722||Other marginal perforations of tympanic membrane, (4) ICD-10 Condition: H728||Other perforations of tympanic membrane, (5) ICD-10 Condition: H729||Unspecified perforation of tympanic membrane, (6) ICD-10 Condition: H730||Acute myringitis, (7) ICD-10 Condition: H731||Chronic myringitis, (8) ICD-10 Condition: H739||Unspecified disorder of tympanic membrane, (9) ICD-10 Condition: H741||Adhesive middle ear disease, (10) ICD-10 Condition: H748||Other specified disorders of middle ear and mastoid, (11) ICD-10 Condition: H744||Polyp of middle ear, (12) ICD-10 Condition: H749||Unspecified disorder of middle earand mastoid, (13) ICD-10 Condition: H710||Cholesteatoma of attic, (14) ICD-10 Condition: H700||Acute mastoiditis, (15) ICD-10 Condition: H701||Chronic mastoiditis, (16) ICD-10 Condition: H702||Petrositis, (17) ICD-10 Condition: H708||Other mastoiditis and related conditions, (18) ICD-10 Condition: H749||Unspecified disorder of middle earand mastoid, (19) ICD-10 Condition: H711||Cholesteatoma of tympanum, (20) ICD-10 Condition: H712||Cholesteatoma of mastoid, (21) ICD-10 Condition: H713||Diffuse cholesteatosis, (22) ICD-10 Condition: H719||Unspecified cholesteatoma, (23) ICD-10 Condition: H920||Otalgia, (24) ICD-10 Condition: H921||Otorrhea, (25) ICD-10 Condition: H922||Otorrhagia, (26) ICD-10 Condition: H610||Chondritis and perichondritis of external ear, (27) ICD-10 Condition: H624||Otitis externa in other diseases classified elsewhere, (28) ICD-10 Condition: H628||Other disorders of external ear indiseases classified elsewhere, (29) ICD-10 Condition: H618||Other specified disorders of external ear, (30) ICD-10 Condition: H661||Chronic tubotympanic suppurative otitis media, (31) ICD-10 Condition: H662||Chronic atticoantral suppurative otitis media, (32) ICD-10 Condition: H669||Otitis media, unspecified, (33) ICD-10 Condition: 4||Measurement and Monitoring,

Intervention / Comparator Agent

Type	Name	Details
Intervention	Ketamine and Propofol	The Ketamine and Propofol group will be given 1mg per kg of Ketamine with 1 mg per kg of Propofol mixed in a sterile, 20 mL single use hypodermic syringe, which will be administered via an infusion pump over 1 minute till the loss of verbal commands or a BIS value of less than or equal to 60 is achieved. Loading dose will be given only once over 1 minute and bolus dose will be given at every 1 minute interval if target BIS value of less than or equal to 60 is not reached.
Comparator Agent	Propofol	The Propofol group will be given 2mg per kg of Propofol in a sterile, 20 mL single use hypodermic syringe, which will be administered via an infusion pump over 1 minute till the loss of verbal commands or a BIS value of less than or equal to 60 is achieved. Loading dose will be given only once over 1 minute and bolus dose will be given at every 1 minute interval if target BIS value of less than or equal to 60 is not reached.

Inclusion Criteria

Age From	18.00 Year(s)
Age To	60.00 Year(s)
Gender	Both
Details	1.American Society of Anaesthesiologists (ASA) Physical Status I and II posted for elective ENT surgeries. 2.Patients of age 18-60 years of either sex. 3.Surgeries with a duration less than or equal to 120 minutes. 4.Patients with normal BMI (18-25 kg/m2).

ExclusionCriteria

Details

1.Patient refusal.
2.History of allergy to the drugs used in the study like Ketamine, Propofol, Fentanyl, Paracetamol.
3.Patients with a history of difficult airway.

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

Sequentially numbered, sealed, opaque envelopes

Blinding/Masking

Participant and Investigator Blinded

Primary Outcome

Outcome	TimePoints
To assess the time required in minutes to attain the target BIS value of less than or equal to 60 in both the groups	BIS value will be monitored at 0 to 10 minutes at 1 minute interval follwed by at 20 minutes and 30 minutes.

Secondary Outcome

Outcome	TimePoints
Time in minutes required from induction to loss of verbal response in both groups of patients.	0 to 10 minutes
Total additional dose of Propofol required in both the groups if BIS more than or equal to 60.	0 to 10 minutes
Measure the haemodynamic parameters, SBP, DBP, MAP- (in mm Hg), Heart rate- (in Beats/ minute).	0 to 10 minutes, 20 minutes & 30 minutes intraoperatively. 0 minute, 30 minutes & 60 minutes post operatively.

Target Sample Size

Total Sample Size="112"
Sample Size from India="112"
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)

01/09/2025

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="1"
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

This study is designed to compare the use of Ketamine-Propofol against Propofol alone in relation to Bispectral Index (BIS) values for the induction of anaesthesia in ENT surgeries. The primary goal of the research is to assess the time taken to reach a BIS value of 60 or lower in both study groups. Secondary objectives include evaluating the duration from induction to the loss of verbal response in both groups, determining how often additional propofol doses are needed when BIS values do not fall to 60 or below within a specified timeframe, and analyzing intraoperative and postoperative hemodynamic parameters.

We hypothesize that patients receiving Ketamine-Propofol will experience a shorter induction time and a reduced incidence of hypotension while still achieving sufficient anaesthesia induction.

The findings of this study will guide the selection of a more effective drug combination for a smoother, faster, and hemodynamically stable induction of anaesthesia in ENT surgeries. Additionally, this research aims to clarify the role of BIS monitoring in ENT surgeries, allowing for timely and appropriate drug dosing to maintain an adequate depth of anaesthesia. This will help anaesthesiologists avoid underdosing or overdosing, leading to smoother emergence and fewer complications.