Effect of Phenylephrine Vs Mephentermine treatment on brain oxygen level during correction of decrease in blood pressure in brain tumour patients under general anaesthesia - A randomized study.
Phase 4
Completed
- Conditions
- Health Condition 1: C00-D49- Neoplasms
- Registration Number
- CTRI/2018/09/015595
- Lead Sponsor
- ational Institute of Mental Health and Neurosciences Bangalore
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 86
Inclusion Criteria
1. Consenting patients aged 18 to 65 years of age
2. Patients scheduled for elective craniotomy for supratentorial brain tumours
3. ASA I â?? II
4. Patients developing hypotension after anaesthesia
Exclusion Criteria
1. Patients refusal
2. Patients with lesions in the anterior pole of frontal lobe
3. Significant co-existing diseases â?? Uncontrolled Hypertension, Diabetes Mellitus
4. Cerebrovascular disease
5. Patients on cardiovascular medications â?? β blockers, Angiotensin Converting Enzyme Inhibitors (ACEI)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. To evaluate the changes in cerebral oxygenation(ScO2) as measured by Near Infrared Spectroscopy (NIRS) between bolus doses of phenylephrine and mephentermine when used to treat hypotension in patients undergoing supratentorial tumour surgery under general anaesthesia <br/ ><br> <br/ ><br>Timepoint: From induction of anaesthesia to extubation or shifting the patient out of operation theatre <br/ ><br>1) Baseline <br/ ><br>2) Post preoxygenation <br/ ><br>3) Pre intubation <br/ ><br>4) Post intubation <br/ ><br>5) At the time of hypotension <br/ ><br>6) Time of administration of the drugs <br/ ><br>7) Every min for a total duration of 10 min after achieving desired MAP level
- Secondary Outcome Measures
Name Time Method 1. To evaluate the changes in physiological variables [Mean Arterial Pressure(MAP), Cardiac Output(CO), Heart Rate (HR), Systemic Vascular Resistance (SVR)] caused by Phenylephrine and Mephentermine in patients with supratentorial tumours <br/ ><br>2. To identify physiological variables (MAP, CO, HR, SVR) responsible for changes in cerebral oxygenation <br/ ><br>3. To observe difference in cerebral oxygenation (ScO2) between those having anaesthesia induced hypotension and those who do not <br/ ><br> <br/ ><br>Timepoint: From induction of anaesthesia to extubation or shifting the patient out of operation theatre <br/ ><br>1) Baseline <br/ ><br>2) Post preoxygenation <br/ ><br>3) Pre intubation <br/ ><br>4) Post intubation <br/ ><br>5) At the time of hypotension <br/ ><br>6) Time of administration of the drugs <br/ ><br>7) Every min for a total duration of 10 min after achieving desired MAP level