A comparative evaluation of the efficacy of propofol versus the combination of propofol and phenylephrine in maintaining hemodynamic stability during induction of general anaesthesia in neurosurgical patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- 1.To measure and compare the mean arterial pressure (MAP), systolic blood pressure(SBP), diastolic blood pressure (DBP), and heart rate (HR) just after induction, every 30 secs for 3 minutes, just after intubation, then every 60 secs for 5 minutes
Study Overview
Brief Summary
In neurosurgical patients, the goals of anaesthesia include the maintenance of adequate cerebral oxygenation, cerebral perfusion pressure (CPP), stable hemodynamics, brain relaxation and avoidance of techniques or agents that affect these factors.The haemodynamic stability is mainly important for most neurosurgical procedures, especially aneurysmal clipping, where maintaining a transmural pressure gradient is of utmost importance to prevent its rupture
Several agents, both inhalational and intravenous (IV), have been used for the induction and maintenance of anaesthesia in neurosurgery patients. Propofol is a very commonly used sedative agent which induces general anaesthesia by facilitation of inhibitory neurotransmission mediated by gamma�’aminobutyric acid.The hypotensive action of propofol has been linked to affect the cerebral perfusion pressure and hence many approaches have been used to mitigate the hypotensive episode.Phenylephrine has emerged as a promising vasopressor drug since its discovery in 1927 and is commonly used for mitigating the hypotension associated with propofol induction
Various studies using different concentrations of phenylephrine have been used in preventing hypotension in healthy adult patients, but we could not find any such study on neurosurgical patients where maintaining hemodynamics is very important.The hypothesis of this study is that combination of propofol and phenylephrine will provide a better intraoperative hemodynamic profile in neurosurgical patients compared to the standard propofol alone induction.
The aim of this study is to compare the efficacy of propofol versus the combination of propofol and phenylephrine in maintaining hemodynamic stability during induction in neurosurgical patients.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •II patients scheduled for elective neurosurgery under general anaesthesia.
Exclusion Criteria
- •1.Patients with known allergies to study drugs.
- •2.Patients with uncontrolled hypertension, coronary artery disease 3.Patients with anticipated difficult airway and patients who require more than 2 attempts or more than 30 sec for direct laryngoscopy 4.Patients with signs and symptoms of elevated ICP.
Outcomes
Primary Outcomes
1.To measure and compare the mean arterial pressure (MAP), systolic blood pressure(SBP), diastolic blood pressure (DBP), and heart rate (HR) just after induction, every 30 secs for 3 minutes, just after intubation, then every 60 secs for 5 minutes
Time Frame: 1.baseline | 2.every 30sec after induction for 3min | 3.60sec after intubation for 5min
2. To measure the number of extra doses of intraoperative vasopressors required if any.
Time Frame: 1.baseline | 2.every 30sec after induction for 3min | 3.60sec after intubation for 5min
Secondary Outcomes
- 1. To measure and compare the mean arterial pressure (MAP), systolic blood pressure(SBP), diastolic blood pressure (DBP), and heart rate (HR) at head pin application, burr hole, craniotomy, bone flap removal, dural opening, dural closure and skin suture.(2. To measure the brain relaxation score intraoperatively between the two groups)