Health Condition 1: C713- Malignant neoplasm of parietal lobe
Conditions
Interventions
Sponsors
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
| Measure | Time 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
| Measure | Time 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
Post Graduate Institute of Medical Education and Research, Chandigarh