SedationNCT04149340
Comparison of Two Sedation Versus Placebo Techniques During Cataract Surgery Under Local Anesthesia
A study testing Cataract surgery in people with Sedation and Cataract, run by University of Liege at 1 site in Belgium.
Trial summary
Check the sedation conditions during topic cataract surgery Read more about this study
- Who is it for?
- Ages 18 to 95 years
- What is being tested?
- Cataract surgery
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jun 2019to 31 Dec 2019
- 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 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Topic cataract surgery
Who cannot join
- NA
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Two Sedation Versus Placebo Techniques on the Patient's Intraoperative Comfort During Cataract Surgery Under Local Anesthesia
Check the sedation conditions during topic cataract surgery
- Being tested
- Cataract surgery
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cataract surgeryDrug
Patient's satisfaction and surgeon's satisfaction was assessed by four Lickert's scales, ranging from one to four. hemodynamic parameters before incision, 10 min post-incision and at the end of the surgery
| Study group | Role | What they receive |
|---|---|---|
| Sufentanil sedation | Other | 3 microgram of Sufentanil IV Receives: Drug: Cataract surgery |
| Placebo sedation | Placebo comparator | 1 ml de NaCl 0,9% Receives: Drug: Cataract surgery |
| Multimodal sedation | Other | Clonidine, sufantil, midazolam, dihydrobenzperidol, ketamine Receives: Drug: Cataract surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient's satisfaction: four Lickert's scales
The patient's satisfaction was assessed by four Lickert's scales, ranging from one (worse outcome )to four (better outcome)
Measured: During cataract surgery
Secondary outcomes (2)
Surgeon's satisfaction: four Lickert's scales
The surgeons's satisfaction was assessed by four Lickert's scales, ranging from one (worse outcome )to four (better outcome)
Measured: During cataract surgery
hemodynamic parameters
The hemodynamic parameters was rated before incision, 10min after incision and at the end of surgery
Measured: Durinf cataract surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2019
- Study start1 Jun 2019
- Primary completion1 Jul 2019
- Study completion31 Dec 2019
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benjamin Javillier, University of Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04149340
- Sponsor's protocol ID
- ANESCATARACT
- Status last verified
- Oct 2020
- First submitted
- 17 Oct 2019
- Last updated
- 6 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Sedation Versus Placebo Techniques on the Patient's Intraoperative Comfort During Cataract Surgery Under Local Anesthesia
- ClinicalTrials.gov ID
- NCT04149340
- Acronym / sponsor ID
- ANESCATARACT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 4 Nov 2019 (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.
Check the sedation conditions during topic cataract surgery
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sufentanil sedation | Other | Drug: Cataract surgery3 microgram of Sufentanil IV |
| Placebo sedation | Placebo comparator | Drug: Cataract surgery1 ml de NaCl 0,9% |
| Multimodal sedation | Other | Drug: Cataract surgeryClonidine, sufantil, midazolam, dihydrobenzperidol, ketamine |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Topic cataract surgery
Key exclusion criteria (1 listed)
- NA
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 |
|---|---|---|
| Cataract surgeryPatient's satisfaction and surgeon's satisfaction was assessed by four Lickert's scales, ranging from one to four. hemodynamic parameters before incision, 10 min post-incision and at the end of the surgery | Drug | Multimodal sedation, Placebo sedation, Sufentanil sedation |
Primary outcome
Patient's satisfaction: four Lickert's scales
Time frame: During cataract surgery
The patient's satisfaction was assessed by four Lickert's scales, ranging from one (worse outcome )to four (better outcome)
2 secondary outcomes
Surgeon's satisfaction: four Lickert's scales
Time frame: During cataract surgery
hemodynamic parameters
Time frame: Durinf cataract surgery
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 6 Oct 2020.
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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.
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 study testing Cataract surgery in people with Sedation and Cataract, run by University of Liege at 1 site in Belgium.
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 1 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 6 Oct 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 Belgium. 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. Some participants in this study may receive a placebo. 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?
Patient's satisfaction: four Lickert's scales (time frame: During cataract surgery). 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 6 Oct 2020.