Completed

NCT Number: NCT03375385

Dexmedetomidine Versus Propofol for Sedation in Stereotactic Brain Biopsy

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.

Completed

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Key information

Conditions

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

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 .

Treatment and study plan

dexmedetomidine/ propofol

Drug

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).

Primary outcomes

the sedation characteristics

Time frame: 4 hours

Ramsay sedation score

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start: 2016
Primary completion: 2017
Study completion: 2017
First posted: Dec 18, 2017
Registry last updated: Apr 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.