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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.

Effect of Phenylephrine Vs Mephentermine treatment on frontal lobe oxygenation during correction of hypotension in supratentorial cerebral tumour patients under general anaesthesia - A randomized controlled study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/09/015595
Enrollment
60
Registered
2018-09-05
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: C00-D49- Neoplasms

Interventions

Intervention1: Vasopressor agents - Phenylephrine and Mephentermine: Inj. Phenylephrine or inj. Mephentermine iv bolus will be given to treat hypotension occurring during induction of general anaesthe

Sponsors

National Institute of Mental Health and Neurosciences Bangalore
Lead Sponsor

Eligibility

Inclusion criteria

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

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)

Design outcomes

Primary

MeasureTime frame
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 Timepoint: From induction of anaesthesia to extubation or shifting the patient out of operation theatre 1) Baseline 2) Post preoxygenation 3) Pre intubation 4) Post intubation 5) At the time of hypotension 6) Time of administration of the drugs 7) Every min for a total duration of 10 min after achieving desired MAP level

Secondary

MeasureTime frame
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 2. To identify physiological variables (MAP, CO, HR, SVR) responsible for changes in cerebral oxygenation 3. To observe difference in cerebral oxygenation (ScO2) between those having anaesthesia induced hypotension and those who do not Timepoint: From induction of anaesthesia to extubation or shifting the patient out of operation theatre 1) Baseline 2) Post preoxygenation 3) Pre intubation 4) Post intubation 5) At the time of hypotension 6) Time of administration of the drugs 7) Every min for a total duration of 10 min after achieving desired MAP level

Countries

India

Contacts

Public ContactDr Roshan Nisal

National Institute of Mental Health and Neurosciences, Bangalore

drvjramesh@gmail.com9844432607

Outcome results

None listed

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