SedationPhase 4NCT05752903
Dexmedetomidine-Propofol Versus Ketamine-Propofol for Sedation of CT Guided Bone Biopsy
A Phase 4 study testing Dexmedetomidine-propofol and Ketamine-Propofol in people with Sedation, run by National Cancer Institute, Egypt at 1 site in Egypt.
Trial summary
This study aims to compare the effectiveness and safety of a dexmedetomidine-propofol combination and a ketamine-Propofol combination for sedation of CT guided bone biopsy. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Sedation
- What is being tested?
- Dexmedetomidine-propofol and Ketamine-Propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 4 Mar 2023to 15 Sep 2023
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Stated willingness to comply with all study procedures and availability for the duration of the study .
- Age between 18 to 60 years old
- American Society of Anesthesiologists (ASA) physical I-III
- Scheduled for CT guided bone biopsy with sedation.
Who cannot join
- Severe heart, lung, and liver disease
- kidney failure
- Bleeding diathesis Allergy to drugs to be used
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between Dexmedetomidine-Propofol and Ketamine-Propofol Administration for Sedation of CT Guided Bone Biopsy: A Randomized Controlled Trial
This study aims to compare the effectiveness and safety of a dexmedetomidine-propofol combination and a ketamine-Propofol combination for sedation of CT guided bone biopsy.
Read the detailed description
Assessment of boney lesions is an common activity in the care of cancer patients. CT guided Percutaneous needle biopsies have a low complication rate. usually, this procedure is done under sedation.
Propofol is a non-barbiturate hypnotic and sedative. It facilitates gamma-aminobutyric acid mediated inhibitory neurotransmission. It's known to have anti-emetic, antipruritic, anticonvulsant and amnestic effects. Despite being effective and potent, Propofol's main disadvantages is its dose-dependent hypotension and respiratory depression .Ketamine is a phencyclidine derivative which acts as a N-methyl-D-aspartate (NMDA) receptor antagonist. It is a dissociative anesthetic and provides some analgesia. It maintains airway reflexes and spontaneous respiration. Combining Propofol and ketamine preserves the sedative and analgesic efficacy while reducing their adverse effects. Dexmedetomidine is a highly selective α2-agonist. It is eight times more specific compared with clonidine. It has a perioperative anxiolytic, sedative properties as well as some analgesic properties .Dexmedetomidine is usually used for mild to moderate sedation and Propofol could be added to deepen the level of sedation
- Conditions
- Sedation
- Being tested
- Dexmedetomidine-propofol, Ketamine-Propofol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine-propofolDrug
Also called precedex
1 microgram/kg dexmedetomidine+2.5 mg/kg propofol intravenous (IV) bolus, 0.5 microgram g/kg/h dexmedetomidine+2.5 mg/kg/h propofol infusion
Ketamine-PropofolDrug
Also called ketofol
1 mg/kg ketamine+2.5 mg/kg propofol iv bolus, 0.25 mg/kg/h ketamine+2.5mg/kg/h propofol infusion
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine-propofol | Active comparator | Dexmedetomidine-propofol bolus will be administered then Dexmedetomidine-propofol infusion continued during the procedure Receives: Drug: Dexmedetomidine-propofol |
| ketamine-propofol | Active comparator | ketamine-propofol bolus will be administered then Dexmedetomidine-propofol infusion continued during the procedure Receives: Drug: Ketamine-Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate
change in heart rate
Measured: before administration (baseline), every 10 minutes during the procedure, every 15 minutes for one hour postoperatively
Secondary outcomes (3)
Mean arterial blood pressure
change in the mean arterial blood pressure
Measured: before administration (baseline), every 10 minutes during the procedure, every 15 minutes for one hour postoperatively
Visual analogue scale (VAS) score for pain
assessment of postoperative pain using the visual analogue scale score. the scale is a straight horizontal line (100 mm). The ends are defined as the extreme limits of pain orientated from the left (no pain) to the right (worst pain).The patient marks on the line the point that they feel represents their perception of their current state.
The VAS score is determined by measuring in millimetres from the left hand end of the line to the point that the patient marks.higher VAS score means worse pain
Measured: every 15 minutes for one hour postoperatively
recovery time
recovery time
Measured: immediately postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2023
- Study start4 Mar 2023
- Primary completion10 Sep 2023
- Study completion15 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SedationStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ahmed Salah abdelgalil, MD, Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05752903
- Sponsor's protocol ID
- AP2207-50109
- Status last verified
- Mar 2023
- First submitted
- 21 Feb 2023
- Last updated
- 28 Sep 2023
- 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 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Dexmedetomidine-Propofol and Ketamine-Propofol Administration for Sedation of CT Guided Bone Biopsy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05752903
- Acronym / sponsor ID
- AP2207-50109
- Conditions
- Sedation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- National Cancer Institute, EgyptUniversity, hospital or other
- Study start
- 4 Mar 2023 (actual)
- Primary completion
- 10 Sep 2023 (actual)
- Study completion
- 15 Sep 2023 (actual)
- First posted
- 3 Mar 2023 (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.
This study aims to compare the effectiveness and safety of a dexmedetomidine-propofol combination and a ketamine-Propofol combination for sedation of CT guided bone biopsy.
Detailed description
Assessment of boney lesions is an common activity in the care of cancer patients. CT guided Percutaneous needle biopsies have a low complication rate. usually, this procedure is done under sedation.
Propofol is a non-barbiturate hypnotic and sedative. It facilitates gamma-aminobutyric acid mediated inhibitory neurotransmission. It's known to have anti-emetic, antipruritic, anticonvulsant and amnestic effects. Despite being effective and potent, Propofol's main disadvantages is its dose-dependent hypotension and respiratory depression .Ketamine is a phencyclidine derivative which acts as a N-methyl-D-aspartate (NMDA) receptor antagonist. It is a dissociative anesthetic and provides some analgesia. It maintains airway reflexes and spontaneous respiration. Combining Propofol and ketamine preserves the sedative and analgesic efficacy while reducing their adverse effects. Dexmedetomidine is a highly selective α2-agonist. It is eight times more specific compared with clonidine. It has a perioperative anxiolytic, sedative properties as well as some analgesic properties .Dexmedetomidine is usually used for mild to moderate sedation and Propofol could be added to deepen the level of sedation
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine-propofol | Active comparator | Drug: Dexmedetomidine-propofolDexmedetomidine-propofol bolus will be administered then Dexmedetomidine-propofol infusion continued during the procedure |
| ketamine-propofol | Active comparator | Drug: Ketamine-Propofolketamine-propofol bolus will be administered then Dexmedetomidine-propofol infusion continued during the procedure |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Stated willingness to comply with all study procedures and availability for the duration of the study .
- Age between 18 to 60 years old
- American Society of Anesthesiologists (ASA) physical I-III
- Scheduled for CT guided bone biopsy with sedation.
Key exclusion criteria (3 listed)
- Severe heart, lung, and liver disease
- kidney failure
- Bleeding diathesis Allergy to drugs to be used
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-propofolAlso: precedex1 microgram/kg dexmedetomidine+2.5 mg/kg propofol intravenous (IV) bolus, 0.5 microgram g/kg/h dexmedetomidine+2.5 mg/kg/h propofol infusion | Drug | Dexmedetomidine-propofol |
| Ketamine-PropofolAlso: ketofol1 mg/kg ketamine+2.5 mg/kg propofol iv bolus, 0.25 mg/kg/h ketamine+2.5mg/kg/h propofol infusion | Drug | ketamine-propofol |
Primary outcome
Heart rate
Time frame: before administration (baseline), every 10 minutes during the procedure, every 15 minutes for one hour postoperatively
change in heart rate
3 secondary outcomes
Mean arterial blood pressure
Time frame: before administration (baseline), every 10 minutes during the procedure, every 15 minutes for one hour postoperatively
Visual analogue scale (VAS) score for pain
Time frame: every 15 minutes for one hour postoperatively
recovery time
Time frame: immediately postoperative
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 28 Sep 2023.
- Individual participant dataSharing planned: No
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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.
Ahmed Salah abdelgalil, MD principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexmedetomidine-propofol and Ketamine-Propofol in people with Sedation, run by National Cancer Institute, Egypt at 1 site in Egypt.
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 4 inclusion and 3 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 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Heart rate (time frame: before administration (baseline), every 10 minutes during the procedure, every 15 minutes for one hour postoperatively). 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 28 Sep 2023.