Study of Dexmedetomidine Effects on Sleep Quality and Fatigue After Major Surgery in Elderly Patients Aged 60 and Older

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What is this study about?

This study focuses on elderly patients aged 60 and above who undergo thoracoscopic lung resection surgery. The research examines how dexmedetomidine, given during the first night after surgery, affects sleep quality and recovery. This medication is administered through intravenous infusion along with sodium chloride solution.

The main purpose of this research is to determine if using dexmedetomidine at night after major surgery can improve sleep quality and reduce post-surgery tiredness and muscle weakness. The medication will be given as an infusion through a vein during the first night following the operation.

During the study, researchers will monitor various aspects of recovery including sleep patterns, physical strength, tiredness levels, and overall well-being. They will use different questionnaires and tests to measure how well patients recover after their surgery. The study will also look at brain activity during sleep and track various body chemicals that indicate how well the body is healing after surgery.

1 Surgery day

You will undergo thoracoscopic lung resection surgery

After the surgery, you will be transferred to the recovery room for monitoring

2 First night after surgery

You will receive either dexmedetomidine or saline solution through an intravenous line

The medication will be given as a continuous infusion during the night

Your brain activity will be monitored using a wearable device that records brain waves (in selected patients)

3 First day after surgery

You will complete several assessments:

Quality of recovery questionnaire to evaluate how well you are recovering

Physical ability test involving standing up and walking (Timed Up and Go test)

Hand strength measurement using a special device

Questionnaires about fatigue and sleep quality

Pain assessment using a 0-10 scale

Short mental status evaluation

4 Follow-up period

You will complete additional questionnaires about:

Overall quality of life

Sleep patterns and quality

Cognitive function assessment by telephone

Blood samples will be collected to measure inflammation markers and melatonin levels

Who Can Join the Study?

  • Must be 60 years of age or older
  • Must be scheduled for thoracoscopic lung resection surgery (a minimally invasive procedure to remove part of the lung through small incisions using a special camera)
  • Can be either male or female
  • Must be able to undergo major surgery
  • Must be willing to receive medication during the first night after surgery
  • Must be willing to have sleep quality monitored after surgery

Who Cannot Join the Study?

  • Age below 60 years old
  • Not scheduled for thoracoscopic lung resection surgery (surgery performed through small incisions in the chest to remove part of the lung)
  • Known allergies or sensitivity to the study medication (dexmedetomidine)
  • Severe heart conditions that could affect heart rate or blood pressure
  • History of sleep disorders or currently taking sleep medications
  • Mental health conditions that could affect sleep patterns or study participation
  • Current participation in other clinical trials
  • Liver or kidney problems that might affect how the body processes medications
  • History of substance abuse within the past year
  • Inability to provide informed consent (clear understanding and agreement to participate)
  • Pregnancy or breastfeeding
  • Taking medications that could interact with the study drug
  • History of severe adverse reactions to anesthesia or similar medications

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Ziekenhuis Oost Limburg Genk Belgium

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
01.04.2024

Trial locations

Dexmedetomidine is a sedative medication that helps patients relax and sleep. It works by affecting certain natural chemicals in the brain. In this trial, it is given during the night after surgery to help elderly patients sleep better. This medication is commonly used in intensive care units and during surgical procedures. It can help reduce anxiety and promote better quality sleep, which may help patients recover better after major surgery. The medication is given through an intravenous line (IV).

Post-surgical Sleep Disturbance – A condition that occurs after major surgery where normal sleep patterns are disrupted. It commonly involves difficulty falling asleep, frequent awakenings, and poor sleep quality during the recovery period. The condition can be particularly pronounced during the first few nights after surgery and may be accompanied by changes in sleep architecture and circadian rhythm disruption.

Post-operative Fatigue – A state of physical and mental exhaustion that develops after surgical procedures. It manifests as decreased energy levels, reduced physical performance, and general weakness. The condition typically begins immediately after surgery and can affect both mental alertness and physical capabilities.

Post-operative Muscle Weakness – A decrease in muscle strength and function that occurs following surgery. It affects both upper and lower body muscle groups, impacting activities such as grip strength and mobility. The condition can influence basic physical activities and movement patterns during the recovery period.

Post-operative Delirium – A temporary state of confusion and reduced awareness that can occur after surgery, particularly in older adults. It involves changes in attention, awareness, and cognitive function. The condition typically develops within the first few days after surgery and can fluctuate throughout the day.

Post-operative Cognitive Dysfunction – A decline in cognitive function that can occur following surgery, affecting memory, attention, and information processing. It is more common in older adults and can impact various aspects of mental function. The condition may affect daily activities requiring mental focus and decision-making.

Trial ID:
2023-510403-22-00
Trial Phase:
Therapeutic confirmatory (Phase III)

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