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Dexmedetomidine Sedation in Orthopedic Surgery

NCT04149626 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2020-01-30

No results posted yet for this study

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.

Conditions

  • Hallux Valgus and Bunion
  • Sedation

Interventions

DRUG

Dexmedetomidine

Sedation using dexmedetomidine (initial bolus dose followed by continuous infusion)

DRUG

Midazolam

Sedation using midazolam (initial bolus dose followed by continuous infusion)

DRUG

Remifentanil

Sedation using remifentanil (initial bolus dose followed by continuous infusion)

Sponsors & Collaborators

  • Maria Tileli

    collaborator UNKNOWN

  • Chryssoula Staikou

    collaborator UNKNOWN

  • Asklepieion Voulas General Hospital

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-29
Primary Completion
2021-12-31
Completion
2022-06-30

Countries

  • Greece

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04149626 on ClinicalTrials.gov