Hallux Valgus and BunionPhase 2NCT04149626
Dexmedetomidine Sedation in Orthopedic Surgery
A Phase 2 study testing Dexmedetomidine, Midazolam and Remifentanil in people with Hallux Valgus and Bunion and Sedation, run by Asklepieion Voulas General Hospital at 1 site in Greece.
Trial summary
60 patients ASA I-III, undergoing orthopedic surgery will be randomly assigned into one of three groups, namely group A (n=20), where dexmedetomidine will be used for sedation (initial bolus dose followed by continuous infusion), group B (n=20) where midazolam will be used for sedation (initial bolus dose followed by… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hallux Valgus and Bunion, Sedation
- What is being tested?
- Dexmedetomidine, Midazolam and Remifentanil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteGreece
- Study dates
- 29 Jan 2020to Jun 2022
- Phase
- Phase 2
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Physical status according to American Society of Anesthesiologists (ASA) I-III Patients scheduled for orthopedic surgery
Who cannot join
- Patient denial, contraindication of spinal anesthesia or any of the agents used in the protocol, BMI above 30, Serious psychiatric, mental and cognitive disorders, Language barrier, illicit substances abuse,
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
Asklepieion Hospital of Voula
Athens, 16673
Alexandros Makris, Dr
About this study
Official title: Prospective, Randomized Comparative Study of Intravenous Dexmedetomidine for Sedation in Orthopedic Surgery Under Regional Anesthesia
60 patients ASA I-III, undergoing orthopedic surgery will be randomly assigned into one of three groups, namely group A (n=20), where dexmedetomidine will be used for sedation (initial bolus dose followed by continuous infusion), group B (n=20) where midazolam will be used for sedation (initial bolus dose followed by continuous infusion) and group C (n=20), where remifentanil will be used for sedation (initial bolus dose followed by continuous infusion). All patients will receive spinal anesthesia. Duration of postoperative analgesia, total dose of patient controlled IV morphine, sedation scores, nausea and vomiting, time of ambulation, sleep quality and patient satisfaction will be recorded for the first postoperative day. Additionally chronic pain on the site of surgery will be recorded in 3 and 6 months postoperatively.
- Conditions
- Hallux Valgus and Bunion, Sedation
- Being tested
- Dexmedetomidine, Midazolam, Remifentanil
- Medical subject headings
- Hallux Valgus, Bunion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Sedation using dexmedetomidine (initial bolus dose followed by continuous infusion)
MidazolamDrug
Sedation using midazolam (initial bolus dose followed by continuous infusion)
RemifentanilDrug
Sedation using remifentanil (initial bolus dose followed by continuous infusion)
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Dexmedetomidine sedation Receives: Drug: Dexmedetomidine |
| Group B | Active comparator | Midazolam sedation Receives: Drug: Midazolam |
| Group C | Active comparator | Remifentanil sedation Receives: Drug: Remifentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative analgesia duration
Time of first demand for analgesia (PCA first bolus dose)
Measured: 24 hours
Secondary outcomes (7)
Postoperative pain: Numerical Rating Scale (NRS)
Numerical Rating Scale (NRS) scores (Range 0-10, 0=no pain, 10=the worse pain ever)
Measured: 24 hours
Morphine consumption
Doses requested, morphine consumption in mg
Measured: 24 hours
Rescue analgesia
Paracetamol in mg consumed
Measured: 24 hours
Sedation
Ramsay Sedation Scale (numeric score from 1 to 6, based on responsiveness of the patient)
Measured: 24 hours
Complications
Measured: 24 hours
Delirium occurence
Nu-DESK scale (presence of disorientation, inappropriate behavior, inappropriate communication,illusions/hallucinations, psychomoter retardation). Each of the 5 items is rated from 0 to 2. A total of 10 is the maximum score. A score of more than 2 identifies the presence of delirium.
Measured: 24 hours
Chronic pain: Graded Chronic Pain Scale (GCPS)
Using of Graded Chronic Pain Scale (GCPS) Grade 0: No pain in prior 6 months Grade 1: Low Intensity - Low Disability Grade II: High Intensity Characteristic Pain Intensity - Low Disability Grade III: High Disability - Moderately Limiting Grade IV: High Disability - Severely Limiting
Measured: 6 months
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 start29 Jan 2020
- Primary completionDec 2021 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hallux Valgus and BunionStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asklepieion Voulas General Hospital
- Sponsor type
- Other government
- Collaborators
- Maria Tileli, Chryssoula Staikou
- Responsible party
- Principal investigator, Alexandros Makris, Asklepieion Voulas General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04149626
- Sponsor's protocol ID
- 14720/29-10-2019
- Status last verified
- Jan 2020
- First submitted
- 31 Oct 2019
- Last updated
- 30 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- 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 30 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized Comparative Study of Intravenous Dexmedetomidine for Sedation in Orthopedic Surgery Under Regional Anesthesia
- ClinicalTrials.gov ID
- NCT04149626
- Acronym / sponsor ID
- 14720/29-10-2019
- Conditions
- Hallux Valgus and Bunion, Sedation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Asklepieion Voulas General HospitalOther government
- Collaborators
- Maria Tileli, Chryssoula Staikou
- Study start
- 29 Jan 2020 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Jun 2022 (estimated)
- 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.
60 patients ASA I-III, undergoing orthopedic surgery will be randomly assigned into one of three groups, namely group A (n=20), where dexmedetomidine will be used for sedation (initial bolus dose followed by continuous infusion), group B (n=20) where midazolam will be used for sedation (initial bolus dose followed by continuous infusion) and group C (n=20), where remifentanil will be used for sedation (initial bolus dose followed by continuous infusion). All patients will receive spinal anesthesia. Duration of postoperative analgesia, total dose of patient controlled IV morphine, sedation scores, nausea and vomiting, time of ambulation, sleep quality and patient satisfaction will be recorded for the first postoperative day. Additionally chronic pain on the site of surgery will be recorded in 3 and 6 months postoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Drug: DexmedetomidineDexmedetomidine sedation |
| Group B | Active comparator | Drug: MidazolamMidazolam sedation |
| Group C | Active comparator | Drug: RemifentanilRemifentanil sedation |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Physical status according to American Society of Anesthesiologists (ASA) I-III Patients scheduled for orthopedic surgery
Key exclusion criteria (1 listed)
- Patient denial, contraindication of spinal anesthesia or any of the agents used in the protocol, BMI above 30, Serious psychiatric, mental and cognitive disorders, Language barrier, illicit substances abuse,
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 |
|---|---|---|
| DexmedetomidineSedation using dexmedetomidine (initial bolus dose followed by continuous infusion) | Drug | Group A |
| MidazolamSedation using midazolam (initial bolus dose followed by continuous infusion) | Drug | Group B |
| RemifentanilSedation using remifentanil (initial bolus dose followed by continuous infusion) | Drug | Group C |
Primary outcome
Postoperative analgesia duration
Time frame: 24 hours
Time of first demand for analgesia (PCA first bolus dose)
7 secondary outcomes
Postoperative pain: Numerical Rating Scale (NRS)
Time frame: 24 hours
Morphine consumption
Time frame: 24 hours
Rescue analgesia
Time frame: 24 hours
Sedation
Time frame: 24 hours
Complications
Time frame: 24 hours
Delirium occurence
Time frame: 24 hours
Chronic pain: Graded Chronic Pain Scale (GCPS)
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2020.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dexmedetomidine, Midazolam and Remifentanil in people with Hallux Valgus and Bunion and Sedation, run by Asklepieion Voulas General Hospital at 1 site in Greece.
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: status not confirmed, as of the sponsor's last update on 30 Jan 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 Greece. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexandros Makris, MD, MSc, PhD (+306947076446, makrisalexandros@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative analgesia duration (time frame: 24 hours). 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 30 Jan 2020.