Failed Conscious Sedation During ProcedurePhase 4NCT03401606
Controlled Sedation for Cataract Surgery
A Phase 4 study testing remifentanil and Dexmedetomidine in people with Failed Conscious Sedation During Procedure, run by Fundación Universitaria de Ciencias de la Salud.
Trial summary
This study evaluates the surgeon and patient´s satisfaction who undergoes cataract surgery using either dexmedetomidine or remifentanil as sedation Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Failed Conscious Sedation During Procedure
- What is being tested?
- remifentanil and Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2014to 30 Jan 2016
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- subject has cataract,
- subject older than 18 years,
- local anesthesia and sedation.
Who cannot join
- general anesthesia,
- history of consumption of sedatives.
About this study
Official title: Dexmedetomidine vs. Remifentanil for Patient and Surgeon Satisfaction in Cataract Surgery Under Controlled Sedation
This study evaluates the surgeon and patient´s satisfaction who undergoes cataract surgery using either dexmedetomidine or remifentanil as sedation
Read the detailed description
This is a double blind, randomized study which evaluates surgeon and patient´s satisfaction whom undergoes cataract surgery. The surgery was done under local anesthesia and sedation.
- Being tested
- remifentanil, Dexmedetomidine
- Keywords
- sedation, dexmedetomidine, remifentanil, cataract surgery, surgeon satisfaction, patient satisfaction
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
remifentanilDrug
remifentanil, 0.25 ng/mL, given intravenous, infusion, until surgery finished
DexmedetomidineDrug
dexmedetomidine, 0.125 mcg/kg/hour, given intravenous, infusion, until surgery finished
| Study group | Role | What they receive |
|---|---|---|
| Remifentanil | Active comparator | remifentanil and dexmedetomidine, 0.25 ng/mL, given intravenous, infusion, until surgery finished. Receives: Drug: remifentanil |
| Dexmedetomidine | Active comparator | dexmedetomidine and remifentanil, 0.125 mcg/kg/hour, given intravenous, infusion, until surgery finished Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgeon and patient satisfaction
It was evaluated with an absolute numerical subjective scale from 1 to 7, where a score of 1 means total dissatisfaction, and 7 complete satisfaction. Scores were evaluated 30 minutes after surgery begun and at the end of the procedure. Results are presented in median and interquartile ranges.
Measured: Intraoperative
Secondary outcomes (4)
Heart rate
Beats per minute (bpm)
Measured: Intraoperative
Mean arterial pressure
Millimeters of mercury (mmHg)
Measured: Intraoperative
Hemoglobin oxygen saturation
Oxygen saturation (%)
Measured: Intraoperative
Surgery duration
Minutes
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2018
- Study start1 Nov 2014
- Primary completion30 Oct 2015
- Study completion30 Jan 2016
Why it stopped: a respiratory depression in remifentanyl group
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Failed Conscious Sedation During ProcedureStudies 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, Outcomes assessor
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Universitaria de Ciencias de la Salud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luis Muñoz, Md, Study director, Fundacion universitaria de ciencias de la salud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03401606
- Sponsor's protocol ID
- 516-3847-33
- Status last verified
- Jan 2018
- First submitted
- 14 Dec 2015
- Last updated
- 17 Jan 2018
- Results posted
- No
- Data monitoring committee
- 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 17 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexmedetomidine vs. Remifentanil for Patient and Surgeon Satisfaction in Cataract Surgery Under Controlled Sedation
- ClinicalTrials.gov ID
- NCT03401606
- Acronym / sponsor ID
- 516-3847-33
- Keywords
- sedation, dexmedetomidine, remifentanil, cataract surgery, surgeon satisfaction, patient satisfaction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: a respiratory depression in remifentanyl group
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Fundación Universitaria de Ciencias de la SaludUniversity, hospital or other
- Study start
- 1 Nov 2014 (actual)
- Primary completion
- 30 Oct 2015 (actual)
- Study completion
- 30 Jan 2016 (actual)
- First posted
- 17 Jan 2018 (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 evaluates the surgeon and patient´s satisfaction who undergoes cataract surgery using either dexmedetomidine or remifentanil as sedation
Detailed description
This is a double blind, randomized study which evaluates surgeon and patient´s satisfaction whom undergoes cataract surgery. The surgery was done under local anesthesia and sedation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remifentanil | Active comparator | Drug: remifentanilremifentanil and dexmedetomidine, 0.25 ng/mL, given intravenous, infusion, until surgery finished. |
| Dexmedetomidine | Active comparator | Drug: Dexmedetomidinedexmedetomidine and remifentanil, 0.125 mcg/kg/hour, given intravenous, infusion, until surgery finished |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- subject has cataract,
- subject older than 18 years,
- local anesthesia and sedation.
Key exclusion criteria (2 listed)
- general anesthesia,
- history of consumption of sedatives.
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 |
|---|---|---|
| remifentanilremifentanil, 0.25 ng/mL, given intravenous, infusion, until surgery finished | Drug | Remifentanil |
| Dexmedetomidinedexmedetomidine, 0.125 mcg/kg/hour, given intravenous, infusion, until surgery finished | Drug | Dexmedetomidine |
Primary outcome
Surgeon and patient satisfaction
Time frame: Intraoperative
It was evaluated with an absolute numerical subjective scale from 1 to 7, where a score of 1 means total dissatisfaction, and 7 complete satisfaction. Scores were evaluated 30 minutes after surgery begun and at the end of the procedure. Results are presented in median and interquartile ranges.
4 secondary outcomes
Heart rate
Time frame: Intraoperative
Mean arterial pressure
Time frame: Intraoperative
Hemoglobin oxygen saturation
Time frame: Intraoperative
Surgery duration
Time frame: Intraoperative
Results and safety
The study was stopped early (reason given: a respiratory depression in remifentanyl group). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2018.
- 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.
Luis Muñoz, Md study director
Fundacion universitaria de ciencias de la salud
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing remifentanil and Dexmedetomidine in people with Failed Conscious Sedation During Procedure, run by Fundación Universitaria de Ciencias de la Salud.
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 2 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: stopped early, as of the sponsor's last update on 17 Jan 2018. 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 was stopped early (reason given: a respiratory depression in remifentanyl group). Results are not available in the source record.
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?
Surgeon and patient satisfaction (time frame: Intraoperative). 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 17 Jan 2018.