Dexmedetomidine Versus Propofol for Sedation in Stereotactic Brain Biopsy

Study Overview
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Brief Summary
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Pre-operative anxiety leads to higher sympathetic stimulation. Propofol in the main drug used during interventional or imaging techniques that need sedation. Also, dexmedetomidine causes sedation, analgesia, sympatholytic properties, without respiratory depression.In stereotactic brain biopsy; patient discomfort due to drilling a hole through the skull and the advancement of the biopsy needle make the patient in need for good sedation and analgesia.

Official Title
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Effect of Dexmedetomidine Versus Propofol on the Onset and Recovery of Sedation in Stereotactic Brain Biopsy A Comparative Study

Conditions
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Adverse Effects in the Therapeutic Use of Other and Unspecified Agents Primarily Acting on the Respiratory System

Intervention / Treatment
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* Drug: dexmedetomidine/ propofol


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Patients with: brain secondaries from the lung/breast/pancreas tuberculoma pyogenic abscess intra-axial supratentorial space occupying lesion with or without hydrocephalus *an average duration of the procedure 1- 2hr 30 min an available caregiver for overnight observation patient relative proximity to the hospital Exclusion criteria Patients with: morbid obesity (body mass index >35 kg/m2) significant comorbidities (a known history of hepatic disease, renal dysfunction, hypertension, and chronic pain) history of drug or alcohol abuse an allergic reaction to one of the study medications anticipated difficult airway uncontrolled epilepsy poor neurological status neuropsychological unsuitability taking psychotropic drugs (benzodiazepines and barbiturates) patients with brain stem lesions (vital areas of brain) un-cooperative refusing adults patients with ventricular drain already inpatient Intubated patients and those who had a prior craniotomy .

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Hemodynamic parameters<br> | Drug: dexmedetomidine/ propofol<br>* The loading and infusion doses of dexmedetomidine hydrochloride and 1% propofol were calculated according to the patient's body weight and diluted to a 10 ml volume (labeled as loading-1 and loading-2) and a 50 ml volume (labeled as infusion-1 and infusion-2).<br>|
| Other: Ramsay sedation score<br> | Drug: dexmedetomidine/ propofol<br>* The loading and infusion doses of dexmedetomidine hydrochloride and 1% propofol were calculated according to the patient's body weight and diluted to a 10 ml volume (labeled as loading-1 and loading-2) and a 50 ml volume (labeled as infusion-1 and infusion-2).<br>|
| Other: Intraoperative side effects<br> | Drug: dexmedetomidine/ propofol<br>* The loading and infusion doses of dexmedetomidine hydrochloride and 1% propofol were calculated according to the patient's body weight and diluted to a 10 ml volume (labeled as loading-1 and loading-2) and a 50 ml volume (labeled as infusion-1 and infusion-2).<br>|
| Other: recovery of sedation<br> | Drug: dexmedetomidine/ propofol<br>* The loading and infusion doses of dexmedetomidine hydrochloride and 1% propofol were calculated according to the patient's body weight and diluted to a 10 ml volume (labeled as loading-1 and loading-2) and a 50 ml volume (labeled as infusion-1 and infusion-2).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the sedation characteristics | Ramsay sedation score | 4 hours |