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Comparison of effect of opioid free anaesthesia with conventional opioid based anaesthesia in major spine surgery

Comparison of effect of opioid free anaesthesia with conventional opioid based anaesthesia in major spine surgery : A Randomized Comparative trial - Nill

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/12/078412
Enrollment
80
Registered
2024-12-20
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: G64- Other disorders of peripheral nervous system Health Condition 2: G64- Other disorders of peripheral nervous system

Interventions

Intervention1: Opioid Based group receive intravenous fentanyl: Administration of fentanyl bolus 2mcg/kg bolus 3 minute prior to induction of anaesthesia followed by infusion fentanyl 0.5 mcg/kg/hour

Sponsors

Dr SN Medical College jodhpur
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: • The Patients of age =18-70 yrs of either gender of ASA category 1,2 and 3 undergoing major spine surgery under general anaesthesia who are haemodynamically stable and declared fit in pre- anaesthetics checkup.

Exclusion criteria

Exclusion criteria: Patient refusal, Patient having known history to allergy to dexmedetomidine, lignocaine and fentanyl and other anaesthetic drugs, patient with history of substance abuse, patient psychiatric illness, cardiac and hepatic insufficiency.

Design outcomes

Primary

MeasureTime frame
To compare the total dose of rescue analgesic requirement up to 48 hours post operatively after major spine surgery.Timepoint: To compare the total dose of rescue analgesic requirement up to 48hours post operatively. From the time patient wakes up from anesthesia to 48 hours post operatively. When VAS is more than 4

Secondary

MeasureTime frame
Postoperative pain intensity by visual analogue score in both the groups. Hemodynamic stability and respiratory parameters (SBP, DBP, MAP, HR, SPO2). The length of post operative hospital stays in both the groups. The side effects such as nausea, vomiting, and respiratory depression, pruritus etc. Post anaesthesia discharge scores according to modified aldrete score. Timepoint: Modified aldrete score will be noted before discharge from post anaesthesia care unit.if score more than and equal to 9 patients will be dicharege. Haemodynamics and respiratory parameters and VAS will be noted on arrival in operation theater than every 15 minutes in intraoperative periods than every hourly upto 6 hours than every 4 hourly upto 24 hours than 6 hourly upto 48 hours. If any side effects and total duration of hospital stay will be also noted.

Countries

India

Contacts

Public ContactDr.Bhagyashree

Dr S N Medical college jodhpur

drpramila82@gmail.com9468940551

Outcome results

None listed

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