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Comparison of Propofol versus ketamine and propofol combination on hypotension in cervical spine surgery

Comparative evaluation of propofol versus ketofol on post induction hypotension in adult patients undergoing cervical spine surgery: A Randomized controlled trial - PROKET-CS trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/04/108289
Enrollment
58
Registered
2026-04-13
Start date
Unknown
Completion date
Unknown
Last updated
2026-04-27

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: injection ketofol: combination drug (ketamine and propofol) 1:5 Patients will receive a ketofol infusion prepared by mixing 40 mL of propofol (10 mg/mL) with 8 mL of ketamine (10 mg/mL)

Sponsors

All India Institute of Medical Sciences jodhpur
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients with clinical cervical myelopathy scheduled for elective cervical spine surgery in prone position (Nurick s grade 1-4) 18-65 years of age Ready to consent

Exclusion criteria

Exclusion criteria: Pregnant patients, uncontrolled hypertension, diabetes mellitus, severe cardiac dysfunction, chronic liver and kidney disease, morbid obesity and psychiatric disease. Nurick s grade 0 and 5

Design outcomes

Primary

MeasureTime frame
primary outcome: To compare the incidence of post induction hypotension with propofol versus ketofol in patients with cervical myelopathy posted for cervical spine surgery. Timepoint: at baseline, 2 minutes post induction, post intubation.

Secondary

MeasureTime frame
1. incidence of hypotension in prone position in two groups. Timepoint: At pre prone, immediately post prone, 5, 10, 15 and 20 minutes post prone position. ;2. Number of episodes of hypotension Timepoint: At baseline, 2 minutes post induction, post intubation, at pre prone, immediately post prone, 5, 10, 15 and 20 minutes post prone position.;3. Number of vasoactive drug doses used Timepoint: At baseline, 2 minutes post induction, post intubation, at pre prone, immediately post prone, 5, 10, 15 and 20 minutes post prone position.;4. time to eye opening, extubation, agitation or delayed recovery. Timepoint: At time of extubation;5. Number of episodes of cerebral desaturation as measured by NIRS Timepoint: At baseline, 2 minutes post induction, post intubation, at pre prone, immediately post prone, 5, 10, 15 and 20 minutes post prone position.;6. Postoperative cognitive function in two groups.Timepoint: Immediate postoperative period

Countries

India

Contacts

Public ContactDr Kirandeep kaur

All India Institute of Medical sciences, Jodhpur

kirandeep9150@gmail.com7527023600

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026