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To Compare the effectivness of Propofol and Ketofol in patients undergoing Spinal surgery under General Anaesthesia

Comparison of Efficacy of Propofol and Ketofol on Spinal Instrumentation Procedure under General Anaesthesia - A Randomized Controlled Trial - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/02/062780
Enrollment
72
Registered
2024-02-19
Start date
Unknown
Completion date
Unknown
Last updated
2024-03-04

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

Conditions

Health Condition 1: M249- Joint derangement, unspecified

Interventions

Intervention1: Ketofol (ketamine + propofol in ratio of 1:2): Intravenous ketofol Infusion (will be prepared by adding 4.5 mL of ketamine (225 mg
50 mg/ mL) , 45 mL of 1% propofol (450 mg
10 mg/mL) and 0.5 ml of normal saline, titrated to maintain BIS between 40-60 intraoperatively Control Intervention1: Propofol: Intravenous propofol infusion (100-150mcg/kg/min) titatred to maintain

Sponsors

Institute of Neurosciences Kolkata
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Aged 18–65 years 2. Either gender 3. ASA grade I and II 4. Scheduled for elective spinal instrumentation surgeries under TIVA

Exclusion criteria

Exclusion criteria: Patient refusal. 2. Patients with hypersensitivity to any of the study drugs 3. Patients with BMI >30 kg/m2 4.ASA grade > II 5. Patients with significant cardiac disease, COPD and restrictive lung disease 6. Patients with significant renal or hepatic impairment 7. Patients with CV junction anomalies and all cervical spinal procedures 8. Redo surgery 9. Deformity corrective surgeries ( like scoliosis) 10. Patients on medications for chronic pain. 11. Patients with neuropsychiatric disorders 12. Duration of surgery more than 4 hours

Design outcomes

Primary

MeasureTime frame
To evaluate and compare intra and post-operative hemodynamic effects of ketofol infusion versus propofol infusion in patients undergoing spinal instrumentation procedures under total intravenous anaesthesia [TIVATimepoint: Before induction Post intubation at 1 min On incision 15 min 30 min 45 min 1 hr 1 hr 15 min 1 hr 30 min 1 hr 45 min 2 hr 2 hr 15 min 2 hr 30 min 2 hr 45 min 3 hr 3 hr 15 min 3 hr 30 min 3 hr 45 min 4 hr At extubation 1 hr post operative 2 hr post operative 4 hr post operative

Secondary

MeasureTime frame
Compare the total amount of propofol consumptionTimepoint: In the intraoperative period;Evaluate and compare the awakening timeTimepoint: During extuabtion;Incidence of PONVTimepoint: In the postoperative period;Postoperative analgesia requirementTimepoint: In the postoperative period;Requirements of rescue analgesiaTimepoint: In the postoperative period

Countries

India

Contacts

Public ContactKallol Deb

Institute of Neurosciences Kolkata

kalloldeb15@gmail.com9830028915

Outcome results

None listed

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