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A study comparing drugs such as lignocaine, dexmedetomidine, lignocaine-dexmedetomidine combination on changes of heart rate and mean blood pressure after skull pin application in head surgery patients

Comparison of intravenous Lignocaine, Dexmedetomidine, Lignocaine-Dexmedetomidine infusion on Hemodynamic changes after skull pin insertion in patients of intracranial tumors: A prospective Double blinded Randomized Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/07/043657
Enrollment
160
Registered
2022-07-04
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-18

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: lignocaine alone: patients will receive lignocaine bolus infusion 2mg/kg over 15 minutes followed by infusion of 1.5mg/kg/hr Intervention2: Dexmedetomidine alone: patients will receive

Sponsors

AIIMS Rishikesh
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1] Patients aged 18-60 years 2] Either gender of ASA I-III patients 3] GCS 13 or more 4] Scheduled for excision and surgical decompression for elective Intracranial Space Occupying Lesions

Exclusion criteria

Exclusion criteria: 1] Refusal to Consent 2] Patients with GCS 3] Patients with psychotic disorders and on medication or therapy 4] Patients with history of substance abuse/ chronic use of opioid analgesics 5] Known/suspected allergy to the study drugs ? Pregnant patients ? Patients with second and third degree Heart Block ? Patients with history of use of ?? blockers

Design outcomes

Primary

MeasureTime frame
Heart Rate, Mean arterial pressureTimepoint: 1] Baseline values 2] Before Induction of anaesthesia 3] After induction of anaesthesia ?Before skull pin insertion ?On application of skull pin and every minute up to first 10 minutes. ?And every 5 minutes for next 20 min.—

Secondary

MeasureTime frame
Blood SugarTimepoint: 1) Baseline 2) following induction of anaesthesia 3) 30 minutes after skull pin insertion;Changes in Bispectral indexTimepoint: During skull pin insertion;Dose of propofol needed to achieve end point of induction of anaesthesiaTimepoint: After induction of anaesthesia;Intraoperative fentanyl requirementTimepoint: At the end of the surgery;Neutrophil-Lymphocyte ratioTimepoint: 1) Preoperative on the day of surgery 2) 30 minutes after skull pin insertion;Serum CortisolTimepoint: 1) Preoperative on the day of surgery 2) 30 minutes after skull pin insertion;Serum ProlactinTimepoint: 1) Preoperative on the day of surgery 2) 30 minutes after skull pin insertion—

Countries

India

Contacts

Public ContactDr Swathi M

AIIMS, Rishikesh

sanjay.anaes@aiimsrishikesh.edu.in9761712630

Outcome results

None listed

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