Dexmedetomidine Sedation in Orthopedic Surgery
Prospective, Randomized Comparative Study of Intravenous Dexmedetomidine for Sedation in Orthopedic Surgery Under Regional Anesthesia
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jan 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 31, 2019
CompletedFirst Posted
Study publicly available on registry
November 4, 2019
CompletedStudy Start
First participant enrolled
January 29, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2022
CompletedJanuary 30, 2020
January 1, 2020
1.8 years
October 31, 2019
January 28, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Postoperative analgesia duration
Time of first demand for analgesia (PCA first bolus dose)
24 hours
Secondary Outcomes (7)
Postoperative pain: Numerical Rating Scale (NRS)
24 hours
Morphine consumption
24 hours
Rescue analgesia
24 hours
Sedation
24 hours
Complications
24 hours
- +2 more secondary outcomes
Study Arms (3)
Group A
ACTIVE COMPARATORDexmedetomidine sedation
Group B
ACTIVE COMPARATORMidazolam sedation
Group C
ACTIVE COMPARATORRemifentanil sedation
Interventions
Sedation using dexmedetomidine (initial bolus dose followed by continuous infusion)
Sedation using remifentanil (initial bolus dose followed by continuous infusion)
Eligibility Criteria
You may qualify if:
- Physical status according to American Society of Anesthesiologists (ASA) I-III Patients scheduled for orthopedic surgery
You may not qualify if:
- 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,
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Asklepieion Voulas General Hospitallead
- Maria Tilelicollaborator
- Chryssoula Staikoucollaborator
Study Sites (1)
Asklepieion Hospital of Voula
Athens, 16673, Greece
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Consultant Anesthesiologist
Study Record Dates
First Submitted
October 31, 2019
First Posted
November 4, 2019
Study Start
January 29, 2020
Primary Completion
December 1, 2021
Study Completion
June 1, 2022
Last Updated
January 30, 2020
Record last verified: 2020-01
Data Sharing
- IPD Sharing
- Will not share