Anesthesia; ReactionNCT04399226
Dexmedetomidine-Propofol and Ketamine-Propofol During Upper Gastrointestinal System Sedation
An observational study of Anesthesia; Reaction, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
Trial summary
Sedation with dexmedetomidine-propofol or ketamine-propofol was planned in patients with upper gastrointestinal endoscopy. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia; Reaction
- What is being tested?
- Dexmedetomidine
- Type of treatment
- Injection or infusion
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Oct 2019to 13 Mar 2020
- How long will I take part?
- 5 Months
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult
Study population: Patients between 18 and 60 years in American Society of Anesthesiologists (ASA) I and II groups were included. Patients that had severe organ disease, allergies to study drugs, refused to participate in the study were excluded. Cases were randomized into the dexmedetomidine-propofol group (Group D, n=30) and ketamine-propofol group (Group K, n=30).
Who may be able to join
- ASA I-II group
- 60 patients
- between the ages of 18 and 60
- planned to have upper gastrointestinal system (UGIS) endoscopy with sedation,
Who cannot join
- severe heart, lung, liver disease
- kidney failure,
- bleeding diathesis
- fever,
- infection,
- electrolyte disorder such as hypokalemia, hypocalcaemia, acid-base disorder, hypothermia, allergy to drugs to be used, and study those who refused to be included were excluded
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Deksmedetomidine-propofol or Ketamine-propofol
Sedation with dexmedetomidine-propofol or ketamine-propofol was planned in patients with upper gastrointestinal endoscopy.
Read the detailed description
Patients between 18 and 60 years in American Society of Anesthesiologists (ASA) I and II groups were included. Patients that had severe organ disease, allergies to study drugs, refused to participate in the study were excluded. Cases were randomized into the dexmedetomidine-propofol group (Group D, n=30) and ketamine-propofol group (Group K, n=30). Cardiac monitoring, peripheral oxygen saturation, bispectral index (BIS) monitoring were performed. Group D received 1mg/kg dexmedetomidine+0.5mg/kg propofol intravenous (iv) bolus, 0.5 μg/kg/h dexmedetomidine+ 0.5 mg/kg/h propfol infusion. Group K received 0.125 mL/kg bolus, 0.125 mL/kg/h ketamine+ propofol = ketofol infusion (ketofol was prepared with 4 mg propofol+2 mg ketamine). Patients were followed up with a Ramsay Sedation Scale (RSS) of≥4. Mean, standard deviation, mean, lowest-highest frequency and ratio values were used in descriptive statistics of the data, SPSS 22.0 program was used for the analyses.
- Conditions
- Anesthesia; Reaction
- Being tested
- Dexmedetomidine
- Keywords
- Dexmedetomidine, Ketamine, Propofol, Sedation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called propofol, ketamine
Group D received 1mg/kg dexmedetomidine+0.5mg/kg propofol intravenous (iv) bolus, 0.5 μg/kg/h dexmedetomidine+ 0.5 mg/kg/h propfol infusion. Group K received 0.125 mL/kg bolus, 0.125 mL/kg/h ketamine+ propofol = ketofol infusion (ketofol was prepared with 4 mg propofol+2 mg ketamine).
What is being measured
The primary outcome is the main question the study is designed to answer.
Demographic data
no difference
Measured: 2 minutes
Secondary outcomes (1)
adverse events
Nausea, vomiting and allergic reaction, cough
Measured: 2 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2020
- Study start18 Oct 2019
- Primary completion20 Feb 2020
- Study completion13 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia; ReactionStudies 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
- Target duration
- 5 Months
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arzu Esen Tekeli, Yuzuncu Yil University
- Investigators
- Arzu Esen TEKELİ, MD, Principal investigator, Yuzuncu Yil University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04399226
- Sponsor's protocol ID
- umutkan
- Status last verified
- May 2020
- First submitted
- 29 Apr 2020
- Last updated
- 22 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: yes
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Deksmedetomidine-propofol or Ketamine-propofol
- ClinicalTrials.gov ID
- NCT04399226
- Acronym / sponsor ID
- umutkan
- Conditions
- Anesthesia; Reaction
- Keywords
- Dexmedetomidine, Ketamine, Propofol, Sedation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- 18 Oct 2019 (actual)
- Primary completion
- 20 Feb 2020 (actual)
- Study completion
- 13 Mar 2020 (actual)
- First posted
- 22 May 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.
Sedation with dexmedetomidine-propofol or ketamine-propofol was planned in patients with upper gastrointestinal endoscopy.
Detailed description
Patients between 18 and 60 years in American Society of Anesthesiologists (ASA) I and II groups were included. Patients that had severe organ disease, allergies to study drugs, refused to participate in the study were excluded. Cases were randomized into the dexmedetomidine-propofol group (Group D, n=30) and ketamine-propofol group (Group K, n=30). Cardiac monitoring, peripheral oxygen saturation, bispectral index (BIS) monitoring were performed. Group D received 1mg/kg dexmedetomidine+0.5mg/kg propofol intravenous (iv) bolus, 0.5 μg/kg/h dexmedetomidine+ 0.5 mg/kg/h propfol infusion. Group K received 0.125 mL/kg bolus, 0.125 mL/kg/h ketamine+ propofol = ketofol infusion (ketofol was prepared with 4 mg propofol+2 mg ketamine). Patients were followed up with a Ramsay Sedation Scale (RSS) of≥4. Mean, standard deviation, mean, lowest-highest frequency and ratio values were used in descriptive statistics of the data, SPSS 22.0 program was used for the analyses.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Target follow-up
- 5 Months
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients between 18 and 60 years in American Society of Anesthesiologists (ASA) I and II groups were included. Patients that had severe organ disease, allergies to study drugs, refused to participate in the study were excluded. Cases were randomized into the dexmedetomidine-propofol group (Group D, n=30) and ketamine-propofol group (Group K, n=30).
Key inclusion criteria (4 listed)
- ASA I-II group
- 60 patients
- between the ages of 18 and 60
- planned to have upper gastrointestinal system (UGIS) endoscopy with sedation,
Key exclusion criteria (6 listed)
- severe heart, lung, liver disease
- kidney failure,
- bleeding diathesis
- fever,
- infection,
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, ketamineGroup D received 1mg/kg dexmedetomidine+0.5mg/kg propofol intravenous (iv) bolus, 0.5 μg/kg/h dexmedetomidine+ 0.5 mg/kg/h propfol infusion. Group K received 0.125 mL/kg bolus, 0.125 mL/kg/h ketamine+ propofol = ketofol infusion (ketofol was prepared with 4 mg propofol+2 mg ketamine). | Drug | – |
Primary outcome
Demographic data
Time frame: 2 minutes
no difference
1 secondary outcome
adverse events
Time frame: 2 minutes
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 22 May 2020.
- Individual participant dataSharing planned: Undecided. yes
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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.
Arzu Esen TEKELİ, MD principal investigator
Yuzuncu Yil University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia; Reaction, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
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 6 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 22 May 2020. 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 Turkey (Türkiye). 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?
Demographic data (time frame: 2 minutes). 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 22 May 2020.