Dexmedetomidine Sedation in Orthopedic Surgery

Phase 2

• Conditions: Hallux Valgus and Bunion; Sedation
• Interventions: Drug: Remifentanil; Drug: Dexmedetomidine; Drug: Midazolam

• Registration Number: NCT04149626
• Lead Sponsor: Asklepieion Voulas General Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-10-31
• Study First Submitted QC: 2019-11-01
• Study First Posted: 2019-11-04
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-28
• Study Start: 2020-01-29
• Last Update Posted: 2020-01-30
• Primary Completion: 2021-12
• Study Completion: 2022-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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,

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group C	Remifentanil	Remifentanil sedation
Group A	Dexmedetomidine	Dexmedetomidine sedation
Group B	Midazolam	Midazolam sedation

Primary Outcome Measures

Name	Time	Method
Postoperative analgesia duration	24 hours	Time of first demand for analgesia (PCA first bolus dose)

Secondary Outcome Measures

Name	Time	Method
Sedation	24 hours	Ramsay Sedation Scale (numeric score from 1 to 6, based on responsiveness of the patient)
Postoperative pain: Numerical Rating Scale (NRS)	24 hours	Numerical Rating Scale (NRS) scores (Range 0-10, 0=no pain, 10=the worse pain ever)
Morphine consumption	24 hours	Doses requested, morphine consumption in mg
Rescue analgesia	24 hours	Paracetamol in mg consumed
Complications	24 hours
Chronic pain: Graded Chronic Pain Scale (GCPS)	6 months	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
Delirium occurence	24 hours	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.

Trial Locations

Locations (1)

Asklepieion Hospital of Voula; 🇬🇷 Athens, Greece