Adverse Effects in the Therapeutic Use of Other and Unspecified Agents Primarily Acting on the Respiratory SystemPhase 4NCT03375385
Dexmedetomidine Versus Propofol for Sedation in Stereotactic Brain Biopsy
A Phase 4 study testing dexmedetomidine/ propofol in people with Adverse Effects in the Therapeutic Use of Other and Unspecified Agents Primarily Acting on the Respiratory System, run by Ain Shams University.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Adverse Effects in the Therapeutic Use of Other and Unspecified Agents Primarily Acting on the Respiratory System
- What is being tested?
- dexmedetomidine/ propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to Dec 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 22Show fewer
- 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 .
Who cannot join
None listed.
About this study
Official title: Effect of Dexmedetomidine Versus Propofol on the Onset and Recovery of Sedation in Stereotactic Brain Biopsy A Comparative Study
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.
- Being tested
- dexmedetomidine/ propofol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dexmedetomidine/ propofolDrug
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 group | Role | What they receive |
|---|---|---|
| Hemodynamic parameters | Other | Not described Receives: Drug: dexmedetomidine/ propofol |
| Ramsay sedation score | Other | Not described Receives: Drug: dexmedetomidine/ propofol |
| Intraoperative side effects | Other | Not described Receives: Drug: dexmedetomidine/ propofol |
| recovery of sedation | Other | Not described Receives: Drug: dexmedetomidine/ propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
the sedation characteristics
Ramsay sedation score
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2017
- Study startSep 2016
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adverse Effects in the Therapeutic Use of Other and Unspecified Agents Primarily Acting on the Respiratory SystemStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ghada M.Samir, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03375385
- Sponsor's protocol ID
- FMASU R44/ 2017
- Status last verified
- Mar 2022
- First submitted
- 4 Dec 2017
- Last updated
- 1 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dexmedetomidine Versus Propofol on the Onset and Recovery of Sedation in Stereotactic Brain Biopsy A Comparative Study
- ClinicalTrials.gov ID
- NCT03375385
- Acronym / sponsor ID
- FMASU R44/ 2017
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 18 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Hemodynamic parameters | Other | Drug: dexmedetomidine/ propofol |
| Ramsay sedation score | Other | Drug: dexmedetomidine/ propofol |
| Intraoperative side effects | Other | Drug: dexmedetomidine/ propofol |
| recovery of sedation | Other | Drug: dexmedetomidine/ propofol |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (22 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dexmedetomidine/ propofolThe 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). | Drug | Hemodynamic parameters, Intraoperative side effects, Ramsay sedation score, recovery of sedation |
Primary outcome
the sedation characteristics
Time frame: 4 hours
Ramsay sedation score
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2022.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing dexmedetomidine/ propofol in people with Adverse Effects in the Therapeutic Use of Other and Unspecified Agents Primarily Acting on the Respiratory System, run by Ain Shams University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the sedation characteristics (time frame: 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2022.