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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.

Efficacy of Ketamine-Propofol versus Propofol on BIS defined induction of anaesthesia in ENT Surgeries- A randomized controlled trial. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/08/092237
Enrollment
112
Registered
2025-08-04
Start date
Unknown
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: H720- Central perforation of tympanic membrane Health Condition 2: H721- Attic perforation of tympanic membrane Health Condition 3: H722- Other marginal perforations of tympanic membrane Health Condition 4: H728- Other perforations of tympanic membrane Health Condition 5: H729- Unspecified perforation of tympanic membrane Health Condition 6: H730- Acute myringitis Health Condition 7: H731- Chronic myringitis Health Condition 8: H739- Unspecified disorder of tympanic membrane

Interventions

Intervention1: 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 w

Sponsors

Kalinga Institute of Medical Sciences, Bhubaneswar
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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).

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

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

Secondary

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

Countries

India

Contacts

Public ContactDr Amrita Panda

Kalinga Institute of Medical Sciences, Bhubaneswar

amrita.panda@kims.ac.in9439862335

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026