Effect of lignocaine and dexmedetomidine on hemodynamic variation , fentanyl and isoflurane consumption intraoperatively in spine surgeries under general anesthesia

EFFECT OF LIGNOCAINE AND DEXMEDITOMIDINE ON HEMODYNAMICS AND CONSUMPTION OF FENTANYL AND ISOFLURANE IN SPINE SURGERY UNDER GENERAL ANESTHESIA- A RANDOMIZED CONTROL TRIAL - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/07/091922

Enrollment

Registered

2025-07-28

Start date

Unknown

Completion date

Unknown

Last updated

2025-08-18

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

Conditions

Health Condition 1: G952- Other and unspecified cord compression Health Condition 2: M498- Spondylopathy in diseases classified elsewhere

Interventions

Intervention1: Dexmedetomidine 0.3mcg/kg/hr , lignocaine 1.5mg/kg/hr: Inj Fentanyl 25mcg per hour and isoflurane consumption intraoperatively Control Intervention1: Dexmedetomidine 0.3mcg/kg/hr , lig

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients posted for elective spine surgeries (laminectomy, spinal tumour resection, posterior lumbar interbody fusion (PLIF), discectomy, instrumentation) lasting up to 2hours. 2. Patients age group of 20 to 60 yrs of either gender. 3. American society of Anesthesiologist (ASA) physical status 1 to

Exclusion criteria

Exclusion criteria: 1.Refusal of patient for the clinical trial. 2.Patient with severe cardiac, renal, pulmonary, hepatic diseses, obesity more than 30kgpermetersquare. 3.Patient on chronic use of beta blockers, analgesic and sedative medications. 4.Allergy to dexmeditomedine and lignocaine . 5.Inability to comprehend pain assessment.

Design outcomes

Primary

Measure	Time frame
Changes in intraoperative mean arterial blood pressureTimepoint: On arrival into OT(Basal value), after study drug bolus , pre-induction, postintubation at 1,2, 3min and every 5min till the end of surgery.	—

Secondary

Measure	Time frame
1 . Severity of surgical site pain assessed will be numerical rating scale NRS 0-10 Injection fentanyl 25 mcg is given as rescue analgesia if NRS more than4 rest . 2.The incidence and severity of PONV will be assessed in PACU in both the groups by applying point verbal descriptive scale VDS If VDS more than 2, inj ondensetron 4 to mg will be given. 3.The incidence and severity of sedation assessed in both the group by Ramsay sedation score7 4.The patients are discharged from PACU after attaining modified Aldrete score of 9out of 10 and overall length of PACU stay is noted .Timepoint: 5minute, 10 minute, 15 minute, 25 minute and 30 minutes followed by every 10 minutes till discharge from PACU.	—

Measure

Time frame

1 . Severity of surgical site pain assessed will be numerical rating scale NRS 0-10 Injection fentanyl 25 mcg is given as rescue analgesia if NRS more than4 rest . 2.The incidence and severity of PONV will be assessed in PACU in both the groups by applying point verbal descriptive scale VDS If VDS more than 2, inj ondensetron 4 to mg will be given. 3.The incidence and severity of sedation assessed in both the group by Ramsay sedation score7 4.The patients are discharged from PACU after attaining modified Aldrete score of 9out of 10 and overall length of PACU stay is noted .Timepoint: 5minute, 10 minute, 15 minute, 25 minute and 30 minutes followed by every 10 minutes till discharge from PACU.

—

Countries

India

Contacts

Public ContactDr Parimala

BMCRC

dr.parimaladu@gmail.com9742530338

Outcome results

None listed

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