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Dexmedetomidine Sedation in Orthopedic Surgery

A

Asklepieion Voulas General Hospital

Status and phase

Unknown
Phase 2

Conditions

Hallux Valgus and Bunion
Sedation

Treatments

Drug: Remifentanil
Drug: Midazolam
Drug: Dexmedetomidine

Study type

Interventional

Funder types

Other

Identifiers

NCT04149626
14720/29-10-2019

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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,

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

60 participants in 3 patient groups

Group A
Active Comparator group
Description:
Dexmedetomidine sedation
Treatment:
Drug: Dexmedetomidine
Group B
Active Comparator group
Description:
Midazolam sedation
Treatment:
Drug: Midazolam
Group C
Active Comparator group
Description:
Remifentanil sedation
Treatment:
Drug: Remifentanil

Trial contacts and locations

1

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Central trial contact

Alexandros Makris, MD, MSc, PhD; Maria Tileli, MD

Data sourced from clinicaltrials.gov

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