Comparison of Ketofol and Propofol-Phenylephrine for hemodynamic stability during neurosurgery anaesthesia

A comparative evaluation of the efficacy of ketofol versus the combination of propofol and phenylephrine in maintaining hemodynamic stability during induction of general anaesthesia in patients undergoing neurosurgery - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/11/076593

Enrollment

Registered

2024-11-11

Start date

Unknown

Completion date

Unknown

Last updated

2024-12-09

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Intravenous ketofol: In group KP- 40 ml of propofol (10 mg/ml) will be mixed with 8 ml of ketamine (10 mg/ml) Control Intervention1: Intravenous propofol with phenylephrine: In group PP

Eligibility

Inclusion criteria

Inclusion criteria: Patients aged between 18-65 years with ASA physical status I and II undergoing elective neurosurgery under general anaesthesia

Exclusion criteria

Exclusion criteria: 1. Nonconsenting patients 2. Patients with known allergies to study drugs 3. Patients with uncontrolled hypertension and coronary artery disease 4. Patients with anticipated difficult airway and patients who require more than 2 attempts or more than 30 seconds for direct laryngoscopy 5. Patients with signs and symptoms of elevated ICP

Design outcomes

Primary

Measure	Time frame
To comparatively evaluate the efficacy of ketofol versus the combination of propofol and phenylephrine in maintaining hemodynamic stability during induction of general anaesthesiaTimepoint: 1. Baseline 2. Just after induction 3. 30 sec after induction 4. 60 sec after induction 5. 90 sec after induction 6. 120 sec after induction 7. 150 sec after induction 8. 180 sec after induction	—

Secondary

Measure	Time frame
1. To comparatively evaluate the efficacy of ketofol versus the combination of propofol and phenylephrine in maintaining hemodynamic stability intraoperatively at defined time points. 2. To comparatively evaluate the efficacy of ketofol versus the combination of propofol and phenylephrine in maintaining brain relaxation at defined time point. 3. To measure the number of extra doses of phenylephrine/esmolol required in both groups to maintain hemodynamic stability at defined time point, if any.Timepoint: 1. Just after intubation 2. 60 sec after intubation 3. 120 sec after intubation 4. 180 sec after intubation 5. 240 sec after intubation 6. 300 sec after intubation 7. Head pinning 8. Burr hole 9. Craniotomy 10. Bone flap removal 11. Dura opening 12. Dura closure 13. Skin suture	—

Measure

Time frame

1. To comparatively evaluate the efficacy of ketofol versus the combination of propofol and phenylephrine in maintaining hemodynamic stability intraoperatively at defined time points. 2. To comparatively evaluate the efficacy of ketofol versus the combination of propofol and phenylephrine in maintaining brain relaxation at defined time point. 3. To measure the number of extra doses of phenylephrine/esmolol required in both groups to maintain hemodynamic stability at defined time point, if any.Timepoint: 1. Just after intubation 2. 60 sec after intubation 3. 120 sec after intubation 4. 180 sec after intubation 5. 240 sec after intubation 6. 300 sec after intubation 7. Head pinning 8. Burr hole 9. Craniotomy 10. Bone flap removal 11. Dura opening 12. Dura closure 13. Skin suture

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Countries

India

Contacts

Public ContactDr Vaishali Waindeskar

All India Institute of Medical Sciences, Bhopal

vaishali.anesth@aiimsbhopal.edu.in9575604490

Outcome results

None listed

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