Sedation and AnalgesiaNCT04597268
Dexmedetomidine Versus Ketamine Versus Midazolam in Endoscopic Procedures
A study testing Dexmedetomidine, Ketamine and Midazolam in people with Sedation and Analgesia, run by National Cancer Institute, Egypt at 1 site in Egypt.
Trial summary
This study aims to assess the safety and efficacy of dexmedetomidine versus ketamine versus midazolam combined with propofol in cancer patients undergoing gastrointestinal endoscopic procedures. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Sedation and Analgesia
- What is being tested?
- Dexmedetomidine, Ketamine and Midazolam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2020to 30 Dec 2022
- Phase
- Interventional
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients scheduled for gastrointestinal endoscopic procedures
- ≥ Age 18 years
- ASA I-II
Who cannot join
- Allergy to any of the used drugs
- impaired renal or liver functions
- hypertensive patients
- patients with cardiovascular
- cerebrovascular disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Efficacy of Dexmedetomidine vs Ketamine vs Midazolam Combined With Propofol in Gastrointestinal Procedures for Cancer Patients
This study aims to assess the safety and efficacy of dexmedetomidine versus ketamine versus midazolam combined with propofol in cancer patients undergoing gastrointestinal endoscopic procedures.
Read the detailed description
Comparison between using intravenous (IV) propofol combined with either IV dexmedetomidine or IV ketamine or IV midazolam; to study the effect of their combination on level of sedation and hemodynamic stability on adult patients scheduled for gastrointestinal endoscopic procedures.
- Conditions
- Sedation and Analgesia
- Being tested
- Dexmedetomidine, Ketamine, Midazolam
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called propofol- dexmedetomidine
intravenous dexmedetomidine 1 mic/kg
KetamineDrug
Also called propofol- ketamine
ketamine 1mg/kg
MidazolamDrug
Also called propofol- midazolam
midazolam 0.05 mg/kg
| Study group | Role | What they receive |
|---|---|---|
| dexmedetomidine | Experimental | IV dexmedetomidine Receives: Drug: Dexmedetomidine |
| ketamine | Experimental | IV ketamine Receives: Drug: Ketamine |
| Midazolam | Active comparator | IV midazolam Receives: Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ramsy sedation score (RSS)
time to achievement of Ramsy sedation score (RSS) 3-4, Ramsy sedation scale score from 1 to 6, 1 meaning anxious and 6 meaning no response to stimulus
Measured: 3 to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start1 Nov 2020
- Primary completion15 Dec 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sedation and AnalgesiaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Walaa Youssef Elsabeeny, National Cancer Institute, Egypt
- Investigators
- Walaa Y Elsabeeny, MD, Principal investigator, LecturerNahla Y Shehab, MD, Study director, Lecturer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04597268
- Sponsor's protocol ID
- AP2007-50110
- Status last verified
- Jan 2023
- First submitted
- 15 Oct 2020
- Last updated
- 10 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data available upon reasonable request through contacting the corresponding author
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Dexmedetomidine vs Ketamine vs Midazolam Combined With Propofol in Gastrointestinal Procedures for Cancer Patients
- ClinicalTrials.gov ID
- NCT04597268
- Acronym / sponsor ID
- AP2007-50110
- Conditions
- Sedation and Analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- National Cancer Institute, EgyptUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 15 Dec 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 22 Oct 2020 (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 assess the safety and efficacy of dexmedetomidine versus ketamine versus midazolam combined with propofol in cancer patients undergoing gastrointestinal endoscopic procedures.
Detailed description
Comparison between using intravenous (IV) propofol combined with either IV dexmedetomidine or IV ketamine or IV midazolam; to study the effect of their combination on level of sedation and hemodynamic stability on adult patients scheduled for gastrointestinal endoscopic procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| dexmedetomidine | Experimental | Drug: DexmedetomidineIV dexmedetomidine |
| ketamine | Experimental | Drug: KetamineIV ketamine |
| Midazolam | Active comparator | Drug: MidazolamIV midazolam |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients scheduled for gastrointestinal endoscopic procedures
- ≥ Age 18 years
- ASA I-II
Key exclusion criteria (5 listed)
- Allergy to any of the used drugs
- impaired renal or liver functions
- hypertensive patients
- patients with cardiovascular
- cerebrovascular disease
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 |
|---|---|---|
| DexmedetomidineAlso: propofol- dexmedetomidineintravenous dexmedetomidine 1 mic/kg | Drug | dexmedetomidine |
| KetamineAlso: propofol- ketamineketamine 1mg/kg | Drug | ketamine |
| MidazolamAlso: propofol- midazolammidazolam 0.05 mg/kg | Drug | Midazolam |
Primary outcome
Ramsy sedation score (RSS)
Time frame: 3 to 6 months
time to achievement of Ramsy sedation score (RSS) 3-4, Ramsy sedation scale score from 1 to 6, 1 meaning anxious and 6 meaning no response to stimulus
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 10 Jan 2023.
- Individual participant dataSharing planned: No. Data available upon reasonable request through contacting the corresponding author
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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.
Walaa Y Elsabeeny, MD principal investigator
Lecturer
Nahla Y Shehab, MD study director
Lecturer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine, Ketamine and Midazolam in people with Sedation and Analgesia, 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 3 inclusion and 5 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 10 Jan 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.
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?
Ramsy sedation score (RSS) (time frame: 3 to 6 months). 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 10 Jan 2023.