Dexmedetomidine Sedation in Orthopedic Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-29

Study Completion Date

2022-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Hallux Valgus and Bunion Sedation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Group A

Dexmedetomidine sedation

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type DRUG

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

Group B

Midazolam sedation

Group Type ACTIVE_COMPARATOR

Midazolam

Intervention Type DRUG

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

Group C

Remifentanil sedation

Group Type ACTIVE_COMPARATOR

Remifentanil

Intervention Type DRUG

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

Interventions

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