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To compare the effectiveness of Dexmedetomidine vs Ketamine along with local anaesthetic Ropivacaine in blocking scalp nerves for awake brain surgeries

Comparison of the efficacy of Dexmedetomidine versus Ketamine as an adjunct to Ropivacaine for Scalp Block during Awake Craniotomy Surgery- A Clinical Comparative Study - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/01/061259
Enrollment
46
Registered
2024-01-09
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: C713- Malignant neoplasm of parietal lobe

Interventions

Intervention1: Dexmedetomidine: Patients receiving 20ml 0.5% Ropivacaine + Dexmedetomidine 1 mics/kg once 15 min before the surgery onset Control Intervention1: Ketamine: Patients receiving 20ml 0.5%

Sponsors

Ankur Luthra
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 46 ASA I and II patients aged between 18-65 years scheduled for Elective Awake Craniotomy surgery for brain tumors will be enrolled in this study

Exclusion criteria

Exclusion criteria: i. Refusal of consent ii. Known allergy to Dexmedetomidine or Ketamine iii. Prior Craniotomy / Chronic analgesic use iv. Coagulopathy v. Schizophrenia or bipolar disorders vi. Uncontrolled anxiety or depression vii. Hepatic or Renal impairment (Stage III or IV) viii. BMI >35 kg/m2 ix. Significant Respiratory disease (COPD or Asthma requiring daily therapy) x. Significant Cardiovascular disease (2nd/3rd degree heart block, Congestive heart failure, symptomatic coronary artery disease)

Design outcomes

Primary

MeasureTime frame
Time to first request of rescue analgesic drug by the patient in the postoperative period which is defined as the time interval between onset of sensory blockade to the first use of rescue analgesic drug as demanded by the patient (NRS more than 4)Timepoint: Within 24 hours whenever NRS more than 4

Secondary

MeasureTime frame
3. To assess the sedation score intraoperatively by Richmond Agitation And Sedation Scale39 (RASS) at 10 min interval after opening of dura for allowing neurological testing (power, speech, calculation, language etc.Timepoint: 10 min and after opening of dura;4. To assess the Pain scores by Numerical Rating Scale (NRS) postoperatively at 2 hourly intervals till 24 hours.Timepoint: 2 hourly till 24 hours;To assess the number of episodes of of adverse events like bradycardia, hypotension, respiratory depression, psychosis by SOMC scale and PONV by 4-Point PONV scaleTimepoint: Till 24 hours;Total rescue analgesic drug requirement in 24 hours.Timepoint: 24 hours;Time to discharge from PACU using Modified Aldrete ScoringTimepoint: Time to discharge;To compare the time needed for onset of sensory block assessed by loss of pin prick sensation every 1 minute. Timepoint: Every 1 minute; To assess the intraoperative hemodynamics (HR, NIBP, MAP, RR, SpO2) at 10 min interval and postoperatively at 2 hours interval till 24 hours. Timepoint: at 10 min interval and postoperatively at 2 hours interval till 24 hours.

Countries

India

Contacts

Public ContactMuhammed Faiz

Post Graduate Institute of Medical Education and Research, Chandigarh

zazzydude979@gmail.com9868057732

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 20, 2026