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Dexamethasone and Dexmedetomidine combination for reducing pain and opioid consumption in spine surgery

To Compare The Opioid Sparing Effects Of Combination Of Dexamethasone And Dexmedetomidine Vs Dexamethasone In Patients Undergoing Lumbar Spine Surgery: A Prospective Double Blind Randomised Placebo Controlled Trial. - Nil

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/12/078106
Enrollment
90
Registered
2024-12-13
Start date
Unknown
Completion date
Unknown
Last updated
2025-02-03

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

Conditions

Health Condition 1: M472- Other spondylosis with radiculopathy

Interventions

Intervention1: Dexamethasone 0.2mg/kg, Dexmedetomidine 0.5-0.7 mcg/kg/hr: Intravenous Dexamethasone will be given 1 hour before surgery. Intravenous Dexmedetomidine infusion will be started after pron

Sponsors

All India Institute of Medical Sciences, New Delhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients of ASA physical status I and II posted for elective lumbar spine surgery of 1 or 2 levels.

Exclusion criteria

Exclusion criteria: 1. Patients refusal 2. Patients belonging to class: ASA physical status III and IV 3. Limitations in understanding use of PCA pump 4. Patients with a preoperative heart rate less than 60 beats per minute 5. Chronic analgesic or steroid use 6. Presence of significant dysfunction like cardiovascular, neurological, respiratory, hepatic or renal 7. History of uncontrolled diabetes mellitus 8. Patients having history of drug abuse 9. Known allergy to drugs

Design outcomes

Primary

MeasureTime frame
Total intravenous Patient Controlled Analgesia (PCA) fentanyl consumption 24 hours postoperativeTimepoint: Total intravenous Patient Controlled Analgesia (PCA) fentanyl consumption 24 hours postoperative

Secondary

MeasureTime frame
Time for first analgesic requirementTimepoint: 24 hours postoperative;Pain scores at rest and during movement at 0 min, 1 hour, 4 hours, 8 hours, 12 hours, 24 hours postoperativeTimepoint: 0 minute, 1,4,8,12,24 hours postoperative;Postoperative nausea and vomitingTimepoint: 0, 15, 30 minutes, 1,2,4,8,12,24 hours postoperative;Hyperglycaemic state of patient till 24 hours after surgeryTimepoint: 1 hour before surgery, 1 hour after surgery, 8th hourly till 24 hours postoperative;Wound healing/infection at 1 weekTimepoint: 7 days postoperative

Countries

India

Contacts

Public ContactVarshini G

All India Institute of Medical Sciences

drparinlalwani@gmail.com9650533388

Outcome results

None listed

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