Dexmedetomidine Versus Propofol for Sedation in Stereotactic Brain Biopsy

NCT ID: NCT03375385

Last Updated: 2022-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2017-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Hemodynamic parameters

Group Type OTHER

dexmedetomidine/ propofol

Intervention Type 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).

Ramsay sedation score

Group Type OTHER

dexmedetomidine/ propofol

Intervention Type 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).

Intraoperative side effects

Group Type OTHER

dexmedetomidine/ propofol

Intervention Type 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).

recovery of sedation

Group Type OTHER

dexmedetomidine/ propofol

Intervention Type 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).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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).

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

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 .
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ghada M.Samir

assistant professor of anaesthesia and intensive care

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

FMASU R44/ 2017

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.