A Phase 2 interventional study of Dexmedetomidine and Midazolam in Hallux Valgus and Bunion and Sedation, sponsored by Asklepieion Voulas General Hospital. Status unknown at 1 site in Greece. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2020-01-30.
Sponsored by Asklepieion Voulas General Hospital · Phase 2, Interventional, and Treatment
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.
157 studies on the registry are indexed under Hallux Valgus; 36 are open to participants now.
This study's planned enrollment of 60 is close to the median of 58 across 119 interventional studies indexed under Hallux Valgus.
Browse Hallux Valgus studies →Asklepieion Voulas General Hospital is the lead sponsor of 13 studies on the registry; 1 is open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Physical status according to (ASA) I-III Patients scheduled for orthopedic surgery
Exclusion Criteria:
Patient denial, of spinal anesthesia or any of the agents used in the protocol, above 30, Serious psychiatric, mental and cognitive disorders, Language barrier, illicit substances abuse,
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Dexmedetomidine sedation
Drug: Dexmedetomidine
Midazolam sedation
Drug: Midazolam
Remifentanil sedation
Drug: Remifentanil
Sedation using dexmedetomidine (initial bolus dose followed by continuous infusion)
Sedation using midazolam (initial bolus dose followed by continuous infusion)
Sedation using remifentanil (initial bolus dose followed by continuous infusion)
Postoperative analgesia duration
Time of first demand for analgesia (PCA first bolus dose)
Time frame: 24 hours
Postoperative pain: Numerical Rating Scale (NRS)
Numerical Rating Scale (NRS) scores (Range 0-10, 0=no pain, 10=the worse pain ever)
Time frame: 24 hours
Morphine consumption
Doses requested, morphine consumption in mg
Time frame: 24 hours
Rescue analgesia
Paracetamol in mg consumed
Time frame: 24 hours
Sedation
Ramsay Sedation Scale (numeric score from 1 to 6, based on responsiveness of the patient)
Time frame: 24 hours
Complications
Time frame: 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.
Time frame: 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
Time frame: 6 months
Plan to share: No
No publications or documents are linked to this record.
Started Jan 2020 (actual). Primary completion is estimated for Dec 2021, 23 months after the start.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Dexmedetomidine · Midazolam · Remifentanil
Asklepieion Voulas General Hospital