Dexmedetomidine Versus Propofol for Sedation in Stereotactic Brain Biopsy

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03375385

Enrollment

Registered

2017-12-18

Start date

2016-09-30

Completion date

2017-12-31

Last updated

2022-04-01

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

Conditions

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

Brief summary

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.

Interventions

DRUGdexmedetomidine/ propofol

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).

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

20 Years to 60 Years

Healthy volunteers

Yes

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 .

Design outcomes

Primary

Measure	Time frame	Description
the sedation characteristics	4 hours	Ramsay sedation score

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026