Dexmedetomidine Versus Propofol for Sedation in Stereotactic Brain Biopsy
NCT ID: NCT03375385
Last Updated: 2022-04-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
60 participants
INTERVENTIONAL
2016-09-30
2017-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Hemodynamic parameters
dexmedetomidine/ 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).
Ramsay sedation score
dexmedetomidine/ 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).
Intraoperative side effects
dexmedetomidine/ 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).
recovery of sedation
dexmedetomidine/ 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).
Interventions
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dexmedetomidine/ 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).
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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 .
20 Years
60 Years
ALL
Yes
Sponsors
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Ain Shams University
OTHER
Responsible Party
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Ghada M.Samir
assistant professor of anaesthesia and intensive care
Other Identifiers
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FMASU R44/ 2017
Identifier Type: -
Identifier Source: org_study_id
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