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
1 other identifier
interventional
60
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Sep 2016
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedFirst Submitted
Initial submission to the registry
December 4, 2017
CompletedFirst Posted
Study publicly available on registry
December 18, 2017
CompletedApril 1, 2022
March 1, 2022
1.2 years
December 4, 2017
March 21, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
the sedation characteristics
Ramsay sedation score
4 hours
Study Arms (4)
Hemodynamic parameters
OTHERRamsay sedation score
OTHERIntraoperative side effects
OTHERrecovery of sedation
OTHERInterventions
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).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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 .
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- assistant professor of anaesthesia and intensive care
Study Record Dates
First Submitted
December 4, 2017
First Posted
December 18, 2017
Study Start
September 1, 2016
Primary Completion
December 1, 2017
Study Completion
December 1, 2017
Last Updated
April 1, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share