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The Impact of Sedation Depth Monitoring for Cognitive Functions and Early Rehabilitation After Major Joints Arthroplasty

NCT06241859 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-03-15

No results posted yet for this study

Summary

Spinal anesthesia is applied for patients undergoing total elective knee replacement surgery. It reduces rates of postoperative complications, improves postoperative pain management, rehabilitation is started earlier and patients more quickly return to the rhythm of ordinary life. According to the literature data, perioperative stress impacts part of cardiovascular complications and exacerbates postoperative pain. It is important that patients during the surgery under spinal anesthesia prefer to sleep. Thus, in order to reduce perioperative stress, patients during surgery are sedated. It is one of the most effective methods.

On the other hand, deep sedation during surgery versus light sedation, is related to more frequent postoperative cognitive impairment and delirium. It leads to worse later surgery results and worse postoperative quality of life, increased risk of falling, prolonged duration of hospitalization, increased expenses.

Conditions

  • Total Knee Replacement Surgery

Interventions

DEVICE

Dräger Infinity Delta series monitor (Dräger, Germany) with Covidien BIS LoC 2 channel module and BIS Quatro (4 electrodes) sensor (Covidien, Ireland)

Dräger Infinity Delta series monitor (Dräger, Germany) with Covidien BIS LoC 2 channel module and BIS Quatro (4 electrodes) sensor (Covidien, Ireland) will be used to maintain a sedation depth between 80-90 value, which corresponds to light sedation definition.

DEVICE

Dräger Infinity Delta series monitor (Dräger, Germany) with Covidien BIS LoC 2 channel module and BIS Quatro (4 electrodes) sensor (Covidien, Ireland)

Dräger Infinity Delta series monitor (Dräger, Germany) with Covidien BIS LoC 2 channel module and BIS Quatro (4 electrodes) sensor (Covidien, Ireland) will be used to monitor sedation depth.

Sponsors & Collaborators

  • Lithuanian University of Health Sciences

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
66 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-10
Primary Completion
2024-04-30
Completion
2025-01-31

Countries

  • Lithuania

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 NCT06241859 on ClinicalTrials.gov