Dexmedetomidine Sedation in Orthopedic Surgery
Primary Purpose
Hallux Valgus and Bunion, Sedation
Status
Unknown status
Phase
Phase 2
Locations
Greece
Study Type
Interventional
Intervention
Dexmedetomidine
Midazolam
Remifentanil
Sponsored by
About this trial
This is an interventional treatment trial for Hallux Valgus and Bunion
Eligibility Criteria
Inclusion Criteria:
Physical status according to American Society of Anesthesiologists (ASA) I-III Patients scheduled for orthopedic surgery
Exclusion Criteria:
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,
Sites / Locations
- Asklepieion Hospital of VoulaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Group A
Group B
Group C
Arm Description
Dexmedetomidine sedation
Midazolam sedation
Remifentanil sedation
Outcomes
Primary Outcome Measures
Postoperative analgesia duration
Time of first demand for analgesia (PCA first bolus dose)
Secondary Outcome Measures
Postoperative pain: Numerical Rating Scale (NRS)
Numerical Rating Scale (NRS) scores (Range 0-10, 0=no pain, 10=the worse pain ever)
Morphine consumption
Doses requested, morphine consumption in mg
Rescue analgesia
Paracetamol in mg consumed
Sedation
Ramsay Sedation Scale (numeric score from 1 to 6, based on responsiveness of the patient)
Complications
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.
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
Full Information
NCT ID
NCT04149626
First Posted
October 31, 2019
Last Updated
January 28, 2020
Sponsor
Asklepieion Voulas General Hospital
Collaborators
Maria Tileli, Chryssoula Staikou
1. Study Identification
Unique Protocol Identification Number
NCT04149626
Brief Title
Dexmedetomidine Sedation in Orthopedic Surgery
Official Title
Prospective, Randomized Comparative Study of Intravenous Dexmedetomidine for Sedation in Orthopedic Surgery Under Regional Anesthesia
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 29, 2020 (Actual)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
June 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asklepieion Voulas General Hospital
Collaborators
Maria Tileli, Chryssoula Staikou
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hallux Valgus and Bunion, Sedation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Active Comparator
Arm Description
Dexmedetomidine sedation
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
Midazolam sedation
Arm Title
Group C
Arm Type
Active Comparator
Arm Description
Remifentanil sedation
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Intervention Description
Sedation using dexmedetomidine (initial bolus dose followed by continuous infusion)
Intervention Type
Drug
Intervention Name(s)
Midazolam
Intervention Description
Sedation using midazolam (initial bolus dose followed by continuous infusion)
Intervention Type
Drug
Intervention Name(s)
Remifentanil
Intervention Description
Sedation using remifentanil (initial bolus dose followed by continuous infusion)
Primary Outcome Measure Information:
Title
Postoperative analgesia duration
Description
Time of first demand for analgesia (PCA first bolus dose)
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Postoperative pain: Numerical Rating Scale (NRS)
Description
Numerical Rating Scale (NRS) scores (Range 0-10, 0=no pain, 10=the worse pain ever)
Time Frame
24 hours
Title
Morphine consumption
Description
Doses requested, morphine consumption in mg
Time Frame
24 hours
Title
Rescue analgesia
Description
Paracetamol in mg consumed
Time Frame
24 hours
Title
Sedation
Description
Ramsay Sedation Scale (numeric score from 1 to 6, based on responsiveness of the patient)
Time Frame
24 hours
Title
Complications
Time Frame
24 hours
Title
Delirium occurence
Description
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
Title
Chronic pain: Graded Chronic Pain Scale (GCPS)
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Physical status according to American Society of Anesthesiologists (ASA) I-III Patients scheduled for orthopedic surgery
Exclusion Criteria:
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,
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexandros Makris, MD, MSc, PhD
Phone
+306947076446
Email
makrisalexandros@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Maria Tileli, MD
Phone
+306955258090
Email
mtileli@gmail.com
Facility Information:
Facility Name
Asklepieion Hospital of Voula
City
Athens
ZIP/Postal Code
16673
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexandros Makris, Dr
12. IPD Sharing Statement
Plan to Share IPD
No
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Dexmedetomidine Sedation in Orthopedic Surgery
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