FindTrial
Sign In

Comparative study between two medications named Lignocaine and Dexmedetomidine as intravenous infusion, for pain during and after the surgical procedure, in patients undergoing general anaesthesia for craniotomy and excision of supratentorial brain tumors

Effect of systemic lidocaine and dexmedetomidine on perioperative analgesia and 3-month outcome in patients undergoing supratentorial craniotomy under inhalational anaesthesia: a randomised control trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/03/050843
Enrollment
63
Registered
2023-03-20
Start date
Unknown
Completion date
Unknown
Last updated
2023-04-03

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

Conditions

Health Condition 1: C710- Malignant neoplasm of cerebrum, except lobes and ventricles

Interventions

Intervention1: First rescue analgesia by using systemic Lidocaine: Loading dose - Lidocaine 1.5 mg/kg (diluted to 20 ml) Maintenance dose - Lidocaine 1.5 mg/kg/h
total drug 1.5 mg x wt x 6 (diluted to 60 ml given at the rate of 10 ml/h) Postoperatively analgesia will be given when the Numerical Rating Scale more than 6 and time to first rescue analgesia will b
total drug 0.5 μg x wt x 6 (diluted to 60 ml at the rate of 10 ml/h) Postoperatively analgesia will be given when the Numerical Rating Scale more than 6 and time to first rescue analgesia will be doc

Sponsors

AIIMS New Delhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. ASA physical status I & II patients 2. BMI 18-30 3. Tumour size 4. Glasgow Coma Score (GCS) 15/15

Exclusion criteria

Exclusion criteria: 1. Features of mass effect (midline shift, herniation) on brain scan. 2. Tumour near Eloquent area of brain requiring neurophysiological monitoring. 3. History of cardiovascular disease (uncontrolled hypertension, brady- or tachy- arrhythmias, heart blocks, coronary heart disease, history of myocardial infarction, CABG, heart failure etc.). 4. History of uncontrolled respiratory, endocrine or renal diseases (TB, asthma, COPD, DM, Hypo or hyperthyroidism, acute or chronic renal failure, electrolyte imbalance etc) 5. History of psychiatric illness and /or medication.

Design outcomes

Primary

MeasureTime frame
To compare the time for first postoperative rescue analgesia between lidocaine, dexmedetomidine and saline groups in patients undergoing supratentorial tumour resection under inhalation anaesthesia.Timepoint: First postoperative rescue analgesia—

Secondary

MeasureTime frame
Emergence from anaesthesiaTimepoint: At emergence;ICU and Hospital stayTimepoint: post extubation to hospital discharge;Intraoperative brain conditionTimepoint: At dura opening;Perioperative complicationsTimepoint: T1 - at intubation, T2 â?? at pin fixation, T3 â?? at skin incision, T4 â?? at dura opening, T5 â?? at skin closure, T6 â?? at emergence, T7 â?? post extubation, T8 - at 1st rescue analgesia, T9 - outcome at hospital discharge, T10 - outcome at 3-month. ;Perioperative hemodynamic parameters (heart rate, mean arterial pressure)Timepoint: T0 â?? Baseline, T1 â?? at intubation, T2 â?? at pin fixation, T3 â?? at skin incision, T4 â?? at dura opening, T5 â?? at skin closure, T6 â?? at emergence, T7 â?? post extubation, T8 - at 1st rescue analgesia.;Total intraoperative opioid consumptionTimepoint: Post extubation—

Countries

India

Contacts

Public ContactDr Gyaninder Pal Singh

AIIMS New Delhi

drgpsingh.aiims@gmail.com9810589220

Outcome results

None listed

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