Comparison of the Effects of Remifentanil and DexmedetomidinePhase 4NCT06403670
Dexmedetomidine and Remifentanil in NORA
A Phase 4 study testing Dexmedetomidine and Remifentanil in people with Comparison of the Effects of Remifentanil and Dexmedetomidine, run by Baskent University Ankara Hospital at 1 site in Turkey (Türkiye).
Trial summary
Endoscopic retrograde cholangiopancreatography (ERCP) procedure is frequently encountered in non-operating room anesthesia applications (NORA). It is a procedure that requires deep sedation and analgesia in terms of gastroenterologist and patient comfort. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Comparison of the Effects of Remifentanil and Dexmedetomidine
- What is being tested?
- Dexmedetomidine and Remifentanil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Dec 2022to 30 Apr 2024
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -ASA 1-3
Who cannot join
- Neurological disease,
- Psychiatric disease,
- Coronary artery disease,
- Long-term sedative drug use,
- Pregnant patients,
- Known allergy to planned drugs
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Baskent University Ankara Hospital
Ankara, Cankaya, 06490
About this study
Official title: The Effects of Dexmedetomidine and Remifentanil on Sedation and Comfort in Non-Operating Room Anesthesia: A Randomized, Double-blind, Controlled Trial
Endoscopic retrograde cholangiopancreatography (ERCP) procedure is frequently encountered in non-operating room anesthesia applications (NORA). It is a procedure that requires deep sedation and analgesia in terms of gastroenterologist and patient comfort. Dexmedetomidine, which is increasingly used in NORA applications, comes to the fore because it does not cause respiratory depression, reduces the stress response, and provides hemodynamic stability. This study aims to compare the effects of dexmedetomidine-propofol (DP) and remifentanil-propofol (RP) combinations on hemodynamic stability, rapid recovery, and patient comfort in patients who underwent ERCP.
- Being tested
- Dexmedetomidine, Remifentanil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Group DP received 0.5 mcg/kg of dexmedetomidine IV for 30 seconds, then dexmedetomidine infusion was started at 0.1-0.7 mcg/kg/h. Propofol 1 mg/kg was administered after waiting for 5 minutes for adequate sedation to develop due to dexmedetomidine's delayed onset of action.
RemifentanilDrug
Group RP received remifentanil 0.1 mcg/kg intravenously for 30 seconds, then remifentanil infusion was started at 0.01-0.1 mcg/kg/min. After waiting 2 minutes to develop a sufficient sedation level, 1 mg/kg of propofol was given.
| Study group | Role | What they receive |
|---|---|---|
| Group Dex | Active comparator | Group Dex received 0.5 mcg/kg of dexmedetomidine IV for 10 minutes, then dexmedetomidine infusion was started at 0.1-0.7 mcg/kg/h. Propofol 1 mg/kg was administered after waiting for 5 minutes for adequate sedation to develop due to dexmedetomidine's delayed onset of action. Receives: Drug: Dexmedetomidine |
| Group Remi | Active comparator | Group RP received remifentanil 0.1 mcg/kg intravenously for 2 minutes, then remifentanil infusion was started at 0.01-0.1 mcg/kg/min. After waiting 2 minutes to develop a sufficient sedation level, 1 mg/kg of propofol was given. Receives: Drug: Remifentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agitation-Sedation
It will be evaluated with a Richmond Agitation-Sedation Scale.
Measured: 0 and 5 minutes after ERCP ends
Hemodynamic stability
Mean arterial pressure with non-invasive blood pressure monitoring (mmHg)
Measured: 5, 10, 15, 25, 35. minutes
Secondary outcomes (3)
Minimize drug dose
Amounts of medication administered throughout the procedure period will be collected.
Measured: 5, 10, 15, 25, 35. minutes
Patient comfort
It will be evaluated by nausea-vomiting and survey.
Measured: 30 minutes after ERCP ends
Rapid recovery
It will be evaluated with a Modified Aldrete Score.
Measured: 30 minutes after ERCP ends
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2024
- Study start17 Dec 2022
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Comparison of the Effects of Remifentanil and DexmedetomidineStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baskent University Ankara Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Uslu, Baskent University Ankara Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06403670
- Sponsor's protocol ID
- NORADEX
- Status last verified
- May 2024
- First submitted
- 1 May 2024
- Last updated
- 8 May 2024
- 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 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Dexmedetomidine and Remifentanil on Sedation and Comfort in Non-Operating Room Anesthesia: A Randomized, Double-blind, Controlled Trial
- ClinicalTrials.gov ID
- NCT06403670
- Acronym / sponsor ID
- NORADEX
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Baskent University Ankara HospitalUniversity, hospital or other
- Study start
- 17 Dec 2022 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 8 May 2024 (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.
Endoscopic retrograde cholangiopancreatography (ERCP) procedure is frequently encountered in non-operating room anesthesia applications (NORA). It is a procedure that requires deep sedation and analgesia in terms of gastroenterologist and patient comfort. Dexmedetomidine, which is increasingly used in NORA applications, comes to the fore because it does not cause respiratory depression, reduces the stress response, and provides hemodynamic stability. This study aims to compare the effects of dexmedetomidine-propofol (DP) and remifentanil-propofol (RP) combinations on hemodynamic stability, rapid recovery, and patient comfort in patients who underwent ERCP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Dex | Active comparator | Drug: DexmedetomidineGroup Dex received 0.5 mcg/kg of dexmedetomidine IV for 10 minutes, then dexmedetomidine infusion was started at 0.1-0.7 mcg/kg/h. Propofol 1 mg/kg was administered after waiting for 5 minutes for adequate sedation to develop due to dexmedetomidine's delayed onset of action. |
| Group Remi | Active comparator | Drug: RemifentanilGroup RP received remifentanil 0.1 mcg/kg intravenously for 2 minutes, then remifentanil infusion was started at 0.01-0.1 mcg/kg/min. After waiting 2 minutes to develop a sufficient sedation level, 1 mg/kg of propofol was given. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -ASA 1-3
Key exclusion criteria (6 listed)
- Neurological disease,
- Psychiatric disease,
- Coronary artery disease,
- Long-term sedative drug use,
- Pregnant patients,
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 |
|---|---|---|
| DexmedetomidineGroup DP received 0.5 mcg/kg of dexmedetomidine IV for 30 seconds, then dexmedetomidine infusion was started at 0.1-0.7 mcg/kg/h. Propofol 1 mg/kg was administered after waiting for 5 minutes for adequate sedation to develop due to dexmedetomidine's delayed onset of action. | Drug | Group Dex |
| RemifentanilGroup RP received remifentanil 0.1 mcg/kg intravenously for 30 seconds, then remifentanil infusion was started at 0.01-0.1 mcg/kg/min. After waiting 2 minutes to develop a sufficient sedation level, 1 mg/kg of propofol was given. | Drug | Group Remi |
Primary outcome
Agitation-Sedation
Time frame: 0 and 5 minutes after ERCP ends
It will be evaluated with a Richmond Agitation-Sedation Scale.
Hemodynamic stability
Time frame: 5, 10, 15, 25, 35. minutes
Mean arterial pressure with non-invasive blood pressure monitoring (mmHg)
3 secondary outcomes
Minimize drug dose
Time frame: 5, 10, 15, 25, 35. minutes
Patient comfort
Time frame: 30 minutes after ERCP ends
Rapid recovery
Time frame: 30 minutes after ERCP ends
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 8 May 2024.
- 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.
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 and Remifentanil in people with Comparison of the Effects of Remifentanil and Dexmedetomidine, run by Baskent University Ankara Hospital 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 1 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 8 May 2024. 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.
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?
Agitation-Sedation (time frame: 0 and 5 minutes after ERCP ends). The study lists 2 primary outcomes in all. 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 8 May 2024.