To evaluate effect of dexmedetomidine versus lidocaine on post operative analgesia in spine surgery

A prospective randomised comparative double blinded study to evaluate the effect of dexmedetomidine versus lidocaine infusion in spine surgery on post operative analgesia at SMS Medical College and attached group of hospitals, Jaipur during 2021-2023.

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/09/046008

Enrollment

Registered

2022-09-28

Start date

Unknown

Completion date

Unknown

Last updated

2022-10-17

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: Dexmedetomidine: Infusion of Dexmedetomidine 0.3mcg/kg/hr given via intravenous route intraoperatively. Control Intervention1: Lidocaine: Infusion lidocaine at the rate of 0.3mg/kg/hr g

Eligibility

Inclusion criteria

Inclusion criteria: Patient undergoing spine surgery with duration within 3 hrs. ASA Grade I&II. Weight 40-80 kg. written and informed consent.

Exclusion criteria

Exclusion criteria: Patients with a known history of hepatic disese, renal dysfunction, hypertension, atrioventricular block. history of hypersensitivity to study medication Patients having chronic pain or concomittantly taking clonidine, methyldopa, beta blockers, benzodiazapines. Patients having unstable Haemodynamic parameters.

Design outcomes

Primary

Measure	Time frame
Mean duration of requirement of first rescue analgesia in post operative period.Timepoint: immediate post op, after 1hr, 4hr,8hr,12hr,till 24 hr.	—

Secondary

Measure	Time frame
haemodynamic parameters(Mean HR, Mean SBP, Mean DBP, Mean BP,SPO2Timepoint: intraoperative(baseline, at begining of infusion, at 5 min,10 min,15 minthen every 15 min till 180 min), and postoperative (immediate,at 1hr, 4hr,8hr,12 hr,24 hr).;mean number of doses of total rescue analgesia required.Timepoint: just after surgery, at 1hr, 4hr,8hr,12hr till 24hr.;Median Ramsay sedation scoreTimepoint: postoperative period(immediate,1hr,4hr,8hr,12hr,24hr);Proportion of cases with any complications and side effectsTimepoint: postoperative period till 24 hr	—

Measure

Time frame

haemodynamic parameters(Mean HR, Mean SBP, Mean DBP, Mean BP,SPO2Timepoint: intraoperative(baseline, at begining of infusion, at 5 min,10 min,15 minthen every 15 min till 180 min), and postoperative (immediate,at 1hr, 4hr,8hr,12 hr,24 hr).;mean number of doses of total rescue analgesia required.Timepoint: just after surgery, at 1hr, 4hr,8hr,12hr till 24hr.;Median Ramsay sedation scoreTimepoint: postoperative period(immediate,1hr,4hr,8hr,12hr,24hr);Proportion of cases with any complications and side effectsTimepoint: postoperative period till 24 hr

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Countries

India

Contacts

Public ContactDr Himani Kaushik

SMS Medical College

drneelu13@gmail.com9782480455

Outcome results

None listed

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