Dexmedetomidine Sedation in Orthopedic Surgery

Sedation Clinical Trial

Official title:

Prospective, Randomized Comparative Study of Intravenous Dexmedetomidine for Sedation in Orthopedic Surgery Under Regional Anesthesia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04149626
• Other study ID #: 14720/29-10-2019
• Status: Recruiting
• Phase: Phase 2
• Start date: January 29, 2020
• Est. completion date: June 2022

Study information

• Verified date: January 2020
• Source: Asklepieion Voulas General Hospital
• Contact: Alexandros Makris, MD, MSc, PhD
• Phone: +306947076446
• Email: makrisalexandros[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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,

Related Conditions & MeSH terms

• Hallux Valgus
• Hallux Valgus and Bunion
• Sedation

Intervention

Drug:
• Dexmedetomidine
Sedation using dexmedetomidine (initial bolus dose followed by continuous infusion)
• Midazolam
Sedation using midazolam (initial bolus dose followed by continuous infusion)
• Remifentanil
Sedation using remifentanil (initial bolus dose followed by continuous infusion)

Locations

Country	Name	City	State
Greece	Asklepieion Hospital of Voula	Athens

Sponsors (3)

Lead Sponsor	Collaborator
Asklepieion Voulas General Hospital	Chryssoula Staikou, Maria Tileli

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative analgesia duration	Time of first demand for analgesia (PCA first bolus dose)	24 hours
Secondary	Postoperative pain: Numerical Rating Scale (NRS)	Numerical Rating Scale (NRS) scores (Range 0-10, 0=no pain, 10=the worse pain ever)	24 hours
Secondary	Morphine consumption	Doses requested, morphine consumption in mg	24 hours
Secondary	Rescue analgesia	Paracetamol in mg consumed	24 hours
Secondary	Sedation	Ramsay Sedation Scale (numeric score from 1 to 6, based on responsiveness of the patient)	24 hours
Secondary	Complications		24 hours
Secondary	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.	24 hours
Secondary	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	6 months