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

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Surgery day

    You will undergo thoracoscopic lung resection surgery

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

  2. Step 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. Step 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. Step 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 trial?

6 criteria

  • 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 trial?

13 criteria

  • 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
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Investigated drugs

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).

What is already known about the treatment

Dexmedetomidine - A selective alpha-2 adrenergic receptor agonist administered intravenously that is primarily used for sedation and pain management in clinical settings. This medication works by reducing the release of norepinephrine in the brain, which helps promote a more natural sleep-like sedation while maintaining respiratory function. It is particularly valuable in perioperative care, especially for elderly patients undergoing major surgeries, as it can improve sleep quality and reduce postoperative fatigue without causing significant respiratory depression. The drug belongs to the class of central-acting alpha-2 agonists and is notable for providing sedation that allows patients to be easily aroused and remain cooperative when stimulated.

Investigated diseases

  • 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 detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-510403-22-00Estimated enrolment102 patientsSponsorZiekenhuis Oost Limburg

sourced from the EU Clinical Trials Register and site verification

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