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Comparison of dexmedetomidine alone vs Dexmedetomidine combined with Ketamine for better blood pressure stability and pain control during spine surgery under general anaesthesia

Comparative evaluation of dexmedetomidine versus ketamine with dexmedetomidine on hemodynamic stability and analgesic efficiency in dorsolumbar spine surgery under general anaesthesia: a double-blinded randomized controlled trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/02/103816
Enrollment
84
Registered
2026-02-13
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-02

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

Conditions

Health Condition 1: G55- Nerve root and plexus compressionsin diseases classified elsewhere

Interventions

Intervention1: Dexmedetomidine plus ketamine vs Dexmedetomidine: (Dexmedetomidine ) alone-1 ug/kg iv over 10 minutes before induction (Ketamine+ dexmedetomidine ) combinatin- 0.5 mg/kg+0.5ug/kg iv

Sponsors

Heritage Institute of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: patients posted for dorsolumbar spine surgery

Exclusion criteria

Exclusion criteria: Patient with known allergy to study drugs Pregnancy and lactating women. Neurological disorder affecting pain perception. Minimal invasive/Endoscopic spinal surgerys. Patient with known Hypertension.

Design outcomes

Primary

MeasureTime frame
Intra-operative hemodynamic stability, assessed by: Heart rate (HR) Systolic blood pressure (SBP) Diastolic blood pressure (DBP) Mean arterial pressure (MAP) Timepoint: Baseline before induction of anesthesia After Induction Post-Intubation after Positioning (Prone) Every 15 min Intraoperatively End of surgery Post -Extubation

Secondary

MeasureTime frame
Post-operative pain intensity, assessed using: Visual Analog Scale (VAS) / Numerical Rating Scale (NRS) at fixed time intervals Total post-operative analgesic/opioid requirement within the first 24 hours Time to first rescue analgesia Incidence of adverse effects, including: Bradycardia Hypotension Nausea & vomitingTimepoint: Postoperative pain will be assessed using Visual Analogue Scale (VAS) at 0, 4, 8, 12, 16, 20 & 24 hours postoperatively. Total rescue analgesic consumption will be recorded over the first 24 hours postoperatively. Adverse effects (bradycardia, hypotension, nausea, vomiting, sedation) will be monitored intraoperatively & for 24 hours postoperatively.

Countries

India

Contacts

Public ContactDr Col Shyamal Maity

Heritage Institute of Medical Sciences

shyamalmaity@rediffmail.com7904635636

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 14, 2026