Dexmedetomidine Versus Propofol for Sedation in Stereotactic Brain Biopsy

Ain Shams University

Status and phase: Completed; Phase 4

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

Treatments: Drug: dexmedetomidine/ propofol

Study type: Interventional

Funder types: Other

Identifiers

NCT03375385

FMASU R44/ 2017

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 20 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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 .

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 4 patient groups

Hemodynamic parameters

Other group

Treatment:

Drug: dexmedetomidine/ propofol

Ramsay sedation score

Other group

Treatment:

Drug: dexmedetomidine/ propofol

Intraoperative side effects

Other group

Treatment:

Drug: dexmedetomidine/ propofol

recovery of sedation

Other group

Treatment:

Drug: dexmedetomidine/ propofol