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Comparision of Dexmedetomidine-Ketamine Anaesthesia and Propofol-Fentanyl Anaesthesia on Nerve Signal monitoring During Cervical spine fusion surgery in Patients with Cervical Myelopathy

Effect of Dexmedetomidine-Ketamine vs. Propofol-Fentanyl Anaesthesia on Motor Evoked Potential Signal Acquisition During Cervical Lateral Mass Fusion in Patients with Cervical Myelopathy: A Randomized Controlled Study - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/02/080449
Enrollment
76
Registered
2025-02-12
Start date
Unknown
Completion date
Unknown
Last updated
2025-03-03

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: Comparison of two anesthetic techniques in cervical lateral mass fusion patients.: Group A (Dexmedetomidine-Ketamine via TCI pump): 1)Dexmedetomidine: Administered using TCI pumps based

Sponsors

Aster Intramural Research Funding
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Adults aged 18-65 years. Diagnosed with cervical myelopathy (confirmed by MRI). Scheduled for cervical lateral mass fusion with intraoperative MEP monitoring

Exclusion criteria

Exclusion criteria: Severe cardiac conditions (eg.severe coronary artery disease, heart failure). Patients with Contraindications for MEP monitoring. History of previous cervical spine surgery. Inability to provide informed consent.

Design outcomes

Primary

MeasureTime frame
The primary outcome will focus on the MEP Amplitudes recorded from the Abductor Pollicis Brevis (APB), Tibialis Anterior (TA), Abductor Hallucis Longus (AHL), and Deltoid musclesTimepoint: At multiple key points during surgery like At Baseline after induction- T0 skin incision-T1 After Decompression-T2 After Screw Fixation-T3 End of surgery-T4

Secondary

MeasureTime frame
MEP Phenotypes: Type 1-5 based on amplitude & latency Patient Movement: Monitored to assess anesthesia effects on motor control. Hemodynamic Stability: Heart rate & blood pressure tracked every 15 minutes. Postoperative Pain: Measured via visual analogue scale (VAS) 6-Month Neurological Recovery: Assessed using Nurick s grading compared to preoperative grade Intraoperative Awareness: Evaluated using the Michigan Awareness Classification New deficits in the postoperative period Timepoint: MEP Phenotypes: At multiple key points during surgery like At Baseline after induction T0 skin incision T1 After Decompression T2 After Screw Fixation T3 End of surgery T4 Patient movements - intraoperatively Heartrate & Bloodpressure- every 15 minutes VAS score at 0,6,12,24 ,48 hours postoperatively Nuricks grading- preop & 6 months postop Michigan awareness scale - on postoperative day 1 New deficits- postoperative period 24-48hours

Countries

India

Contacts

Public ContactDheeraj Masapu

Aster Whitefield Hospital

dheerajmasapu@gmail.com9591964327

Outcome results

None listed

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