Postoperative FatiguePhase 4DEXSLEEPNCT06480539
The Effect of Nocturnal Dexmedetomidine on Postoperative Sleep Quality and Fatigue After Major Surgery in Elderly Patients: DEXSLEEP Study
A Phase 4 study testing Dexmedetomidine in people with Postoperative Fatigue and Postoperative Sleep Disturbances, run by Ziekenhuis Oost-Limburg at 1 site in Belgium.
Trial summary
In the aftermath of major surgery, many patients suffer from pain, fatigue, reduced general well-being, and cognitive dysfunction. Another common concern after major surgery is sleep impairment and there is little known about its effect on postoperative morbidity, especially postoperative fatigue and muscle function. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Postoperative Fatigue, Postoperative Sleep Disturbances, Surgical Stress Response
- What is being tested?
- Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 1 siteBelgium
- Study dates
- 3 Jun 2024to 28 Apr 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged 60 years or older;
- scheduled for thoracoscopic lung surgery.
Who cannot join
- lack of informed consent or inability to give informed consent;
- ≥ 2nd-degree atrioventricular block without pacemaker;
- uncontrolled hypotension (blood pressure \< 90/60 mmHg);
- known hypersensitivity to dexmedetomidine or to any of the excipients;
- acute cerebrovascular conditions;
- urgent, not elective surgery.
Trial locations and contacts
1 site in 1 country.
About this study
In the aftermath of major surgery, many patients suffer from pain, fatigue, reduced general well-being, and cognitive dysfunction. Another common concern after major surgery is sleep impairment and there is little known about its effect on postoperative morbidity, especially postoperative fatigue and muscle function.
Dexmedetomidine has been shown to possibly improve postoperative sleep quality in critically ill patients. However, whether the administration of dexmedetomidine translates into reduced postoperative fatigue and/or weakness and improved enhanced recovery after surgery by improving sleep, is currently unknown.
The DEXSLEEP study will evaluate the effect of nocturnal administration of dexmedetomidine, as compared to placebo (i.e. no dexmedetomidine), on postoperative quality of recovery, postoperative fatigue and muscle weakness.
Read the detailed description
Due to the increase in life expectancy in the developing world, the number of elderly patients undergoing (major) surgery is expected to increase in the coming years. These elderly patients, even healthy older adults, have a reduced physiologic reserve such that organ systems may be compromised during and after surgical stress, placing them at greater risk of morbidity and mortality after surgery.
A common concern after surgery is sleep impairment. Patients often develop significant sleep disturbances after major surgery and particular elderly patients are more prone to develop sleep disturbances when compared to younger patients. Sleep plays an essential role in the homeostasis of multiple organ systems and cognitive function. A good night sleep is deemed essential for a good functional recovery. Taking this into account, it seems logical that postoperative sleep disturbances could be a contributing factor to postoperative fatigue, which is reported by patients as one of the most distressing symptoms after surgery and is thought to be the chief contributor to delayed recovery after surgery.
The endocrinological surgical response probably plays an essential role in postoperative sleep disturbances experienced by surgical patients by causing (neuro)inflammation. Keeping this in mind, dexmedetomidine might be an interesting pharmacological intervention since it has the ability to attenuate several factors that contribute to postoperative sleep disturbances including the endocrinological surgical stress response. However, whether the nocturnal administration of dexmedetomidine translates into improved postoperative sleep quality after elective major surgery, subsequently reduced postoperative fatigue and muscle weakness, and improved enhanced recovery after surgery by improving sleep, is currently unknown.
Therefore, the main objective of this prospective clinical trial is to evaluate the effect of nocturnal dexmedetomidine on early postoperative outcomes, i.e. quality of recovery, in elderly patients (60 years or older) undergoing major surgery.
- Being tested
- Placebo, Dexmedetomidine
- Keywords
- Major surgery, Enhanced Recovery After Surgery (ERAS), Elderly patients, Quality of recovery, Postoperative fatigue, Postoperative muscle weakness, Postoperative sleep disturbances, Dexmedetomidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
The comparator is a placebo, namely pure saline (NaCl 0.9%), which will be administered following the same regimen as the intervention.
DexmedetomidineDrug
Nocturnal administration of dexmedetomidine (0.2-1.0 mcg/kg/h) during the first night after surgery. Dexmedetomidine infusion, not preceded by a bolus administration, will be started at 0.4 mcg/kg/h in the intervention group at 8 p.m. the day of surgery. Dexmedetomidine infusion will be titrated every 30 minutes with 0.1 mcg/kg/h steps until a RASS of -1 to -3 (drowsy, light to moderate sedation) is reached. The infusion will be discontinued at 6 a.m. the next morning.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | The comparator is a placebo, namely pure saline (NaCl 0.9%), which will be administered following the same regimen as the intervention. Receives: Drug: Placebo |
| Dexmedetomidine | Active comparator | Nocturnal administration of dexmedetomidine (0.2-1.0 mcg/kg/h) during the first night after surgery. Dexmedetomidine infusion, not preceded by a bolus administration, will be started at 0.4 mcg/kg/h in the intervention group at 8 p.m. the day of surgery. Dexmedetomidine infusion will be titrated every 30 minutes with 0.1 mcg/kg/h steps until a RASS of -1 to -3 (drowsy, light to moderate sedation) is reached. The infusion will be discontinued at 6 a.m. the next morning. Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Recovery (QoR)
Quality of Recovery Score (QoR-15 score) is a patient-reported outcome measurement which will be used to assess the early postoperative health status of the patient after surgery and anesthesia, i.e. the quality of recovery. The score is arbitrary and ranges from 0 to 150, the higher the score the better the quality of recovery. QoR-15 will be assessed on day 1 as compared to preoperatively.
Measured: Pre-operative and postoperative day 1
Secondary outcomes (13)
Sleep-wake cycle (MCTQ)
To evaluate each patient's sleep-wake cycle, the sleep-wake timing will be evaluated with the Munich Chronotype Questionnaire (MCTQ) 3 days before surgery, which will be used to calculate the baseline midpoint sleep and chronotype.
Measured: 3 days before surgery
Sleep pattern (CSD)
Sleep will be evaluated with the Consensus Sleep Diary (CSD) to have a more in depth insight into the evolution of sleep pre- and postoperatively. The diary will be filled in daily starting 3 days before surgery until 7 days after surgery.
Measured: 10 consecutive nights, starting 3 days before surgery
Postoperative fatigue - Chalder fatigue questionnaire
To assess general fatigue a fatigue questionnaire, the Chalder fatigue questionnaire, will be taken on day 1, day 3, day 5 and day 28 postoperatively and be compared to the preoperative value. The questionnaire consists of 11 items that assess both physical and mental aspects of fatigue. Respondents rate each item ranging from 0 to 3, the scores are then totaled to provide a measure of overall fatigue, a higher score meaning more severe fatigue.
Measured: Pre-operative and postoperative day 1, day 3, day 5 and day 28
Health-related quality of life (EQ-5D)
The EQ-5D is used for measuring health-related quality of life. EQ-5D provides a simple descriptive profile and a single index value for health status, both can be used to assess the overall health. The descriptive profile consists of five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels of severity: no problems, slight problems, moderate problems, severe problems, or not able. Respondents select the level that best describes their current health status. The EQ-5D also includes a visual analog scale (VAS) where respondents rate their current health status on a scale from 0 to 100, with 0 being the worst imaginable health state and 100 being the best imaginable health state. The EQ-5D questionnaire will be taken preoperatively and on day 28 postoperatively.
Measured: Pre-operative and postoperative day 28
Subjective sleep quality (PSQI)
To assess subjective sleep quality over a one-month time interval the Pittsburgh Sleep Quality Index (PSQI) will be used. The PSQI consists of 19 items that assess different components of sleep, including sleep latency, sleep duration, sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction due to poor sleep quality. Each item is rated on a scale from 0 to 3, with higher scores indicating worse sleep quality. The scores from all 19 items are summed to provide a total score ranging from 0 tot 21, with higher scores indicating poorer sleep quality. The questionnaire will be filled in two times: 3 days before surgery and 28 days after surgery.
Measured: 3 days before surgery and postoperative day 28
Postoperative fatigue - Fatigue VAS scale
To assess fatigue in detail, the fatigue visual analog scale (VAS) will be taken on day 1, day 3, day 5 and day 28 postoperatively and be compared to the preoperative value. The VAS is a tool to measure the severity of fatigue subjectively experienced by individuals. It involves a simple assessment where respondents score their fatigue on a series of questions, with 0 representing "no fatigue" and 10 representing "worst possible fatigue".
Measured: Pre-operative and postoperative day 1, day 3, day 5 and day 28
Subjective sleep quality first night after surgery (RCSQ)
The Richards-Campbell Sleep Questionnaire (RCSQ) will be taken on day 1 to evaluate the subjective quality of the first night after surgery. The RCSQ consists of a series of questions (five items) that ask individuals to rate various aspects of their sleep experience. Respondents rate each item on a visual analog scale, higher scores indicating worse sleep quality.
Measured: Postoperative day 1
Postoperative delirium
To assess postoperative delirium the 3 minute confusion assessment method (3D-CAM) questionnaire will be done on day 1, day 3 and day 5 postoperatively. The 3D-CAM consists of a structured interview and cognitive testing. Based on the patient's responses and performance, it is determined whether delirium is present or not.
Measured: Postoperative day 1, day 3 and day 5
Postoperative cognitive impairment
To assess postoperative cognitive impairment the Telephone Interview for Cognitive Status (TICS-40) will be done preoperatively and on day 28 postoperatively, this interview is a valid alternative for the Mini-Mental State Examination with the advantage that it does not have to be administered face-to-face. The TICS-40 is compromised of 9 items that result in a maximum score of 40, with higher scores indicating better cognitive function.
Measured: Pre-operative and postoperative day 28
Quality of Recovery (QoR)
Quality of Recovery Score (QoR-15 score) is a patient-reported outcome measurement which will be used to assess the early postoperative health status of the patient after surgery and anesthesia, i.e. the quality of recovery. The score is arbitrary and ranges from 0 to 150, the higher the score the better the quality of recovery. The QoR-15 will be assessed on day 3 and day 5 (if the patient is still in the hospital) as compared to preoperatively.
Measured: Pre-operative and postoperative day 3 and day 5
Postoperative muscle strength (upper extremity)
Postoperative muscle strength (upper extremity) will be assessed by comparing the handgrip strength of the dominant hand, measured on day 1, day 3 and day 5 following surgery as compared to the preoperative value. The test will only be performed if the patient is still in the hospital.
Measured: Pre-operative and postoperative day 1, day 3 and day 5
Postoperative muscle strength (lower extremity)
Postoperative muscle strength (lower extremity) and physical ability will be assessed by the Timed Up and Go (TUG) test, on day 3 and day 5 following surgery as compared to the preoperative value. The test will only be performed if the patient is still in the hospital.
Measured: Pre-operative and postoperative day 3 and day 5
Sleeping EEG pattern
Electroencephalographic (EEG) readings will be conducted during the first postoperative night (when administering study medication) to asses sleep architecture.
Measured: First postoperative night
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2024
- Study start3 Jun 2024
- Primary completion25 Mar 2026
- Study completion28 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative FatigueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ziekenhuis Oost-Limburg
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06480539
- Sponsor's protocol ID
- Z-2023104
- Acronym
- DEXSLEEP
- Status last verified
- Aug 2025
- First submitted
- 11 Apr 2024
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Nocturnal Dexmedetomidine on Postoperative Sleep Quality and Fatigue After Major Surgery in Elderly Patients: DEXSLEEP Study
- ClinicalTrials.gov ID
- NCT06480539
- Acronym / sponsor ID
- DEXSLEEP / Z-2023104
- Keywords
- Major surgery, Enhanced Recovery After Surgery (ERAS), Elderly patients, Quality of recovery, Postoperative fatigue, Postoperative muscle weakness, Postoperative sleep disturbances, Dexmedetomidine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Ziekenhuis Oost-LimburgUniversity, hospital or other
- Study start
- 3 Jun 2024 (actual)
- Primary completion
- 25 Mar 2026 (actual)
- Study completion
- 28 Apr 2026 (actual)
- First posted
- 28 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In the aftermath of major surgery, many patients suffer from pain, fatigue, reduced general well-being, and cognitive dysfunction. Another common concern after major surgery is sleep impairment and there is little known about its effect on postoperative morbidity, especially postoperative fatigue and muscle function.
Dexmedetomidine has been shown to possibly improve postoperative sleep quality in critically ill patients. However, whether the administration of dexmedetomidine translates into reduced postoperative fatigue and/or weakness and improved enhanced recovery after surgery by improving sleep, is currently unknown.
The DEXSLEEP study will evaluate the effect of nocturnal administration of dexmedetomidine, as compared to placebo (i.e. no dexmedetomidine), on postoperative quality of recovery, postoperative fatigue and muscle weakness.
Detailed description
Due to the increase in life expectancy in the developing world, the number of elderly patients undergoing (major) surgery is expected to increase in the coming years. These elderly patients, even healthy older adults, have a reduced physiologic reserve such that organ systems may be compromised during and after surgical stress, placing them at greater risk of morbidity and mortality after surgery.
A common concern after surgery is sleep impairment. Patients often develop significant sleep disturbances after major surgery and particular elderly patients are more prone to develop sleep disturbances when compared to younger patients. Sleep plays an essential role in the homeostasis of multiple organ systems and cognitive function. A good night sleep is deemed essential for a good functional recovery. Taking this into account, it seems logical that postoperative sleep disturbances could be a contributing factor to postoperative fatigue, which is reported by patients as one of the most distressing symptoms after surgery and is thought to be the chief contributor to delayed recovery after surgery.
The endocrinological surgical response probably plays an essential role in postoperative sleep disturbances experienced by surgical patients by causing (neuro)inflammation. Keeping this in mind, dexmedetomidine might be an interesting pharmacological intervention since it has the ability to attenuate several factors that contribute to postoperative sleep disturbances including the endocrinological surgical stress response. However, whether the nocturnal administration of dexmedetomidine translates into improved postoperative sleep quality after elective major surgery, subsequently reduced postoperative fatigue and muscle weakness, and improved enhanced recovery after surgery by improving sleep, is currently unknown.
Therefore, the main objective of this prospective clinical trial is to evaluate the effect of nocturnal dexmedetomidine on early postoperative outcomes, i.e. quality of recovery, in elderly patients (60 years or older) undergoing major surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboThe comparator is a placebo, namely pure saline (NaCl 0.9%), which will be administered following the same regimen as the intervention. |
| Dexmedetomidine | Active comparator | Drug: DexmedetomidineNocturnal administration of dexmedetomidine (0.2-1.0 mcg/kg/h) during the first night after surgery. Dexmedetomidine infusion, not preceded by a bolus administration, will be started at 0.4 mcg/kg/h in the intervention group at 8 p.m. the day of surgery. Dexmedetomidine infusion will be titrated every 30 minutes with 0.1 mcg/kg/h steps until a RASS of -1 to -3 (drowsy, light to moderate sedation) is reached. The infusion will be discontinued at 6 a.m. the next morning. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- aged 60 years or older;
- scheduled for thoracoscopic lung surgery.
Key exclusion criteria (6 listed)
- lack of informed consent or inability to give informed consent;
- ≥ 2nd-degree atrioventricular block without pacemaker;
- uncontrolled hypotension (blood pressure \< 90/60 mmHg);
- known hypersensitivity to dexmedetomidine or to any of the excipients;
- acute cerebrovascular conditions;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboThe comparator is a placebo, namely pure saline (NaCl 0.9%), which will be administered following the same regimen as the intervention. | Drug | Placebo |
| DexmedetomidineNocturnal administration of dexmedetomidine (0.2-1.0 mcg/kg/h) during the first night after surgery. Dexmedetomidine infusion, not preceded by a bolus administration, will be started at 0.4 mcg/kg/h in the intervention group at 8 p.m. the day of surgery. Dexmedetomidine infusion will be titrated every 30 minutes with 0.1 mcg/kg/h steps until a RASS of -1 to -3 (drowsy, light to moderate sedation) is reached. The infusion will be discontinued at 6 a.m. the next morning. | Drug | Dexmedetomidine |
Primary outcome
Quality of Recovery (QoR)
Time frame: Pre-operative and postoperative day 1
Quality of Recovery Score (QoR-15 score) is a patient-reported outcome measurement which will be used to assess the early postoperative health status of the patient after surgery and anesthesia, i.e. the quality of recovery. The score is arbitrary and ranges from 0 to 150, the higher the score the better the quality of recovery. QoR-15 will be assessed on day 1 as compared to preoperatively.
13 secondary outcomes
Sleep-wake cycle (MCTQ)
Time frame: 3 days before surgery
Sleep pattern (CSD)
Time frame: 10 consecutive nights, starting 3 days before surgery
Postoperative fatigue - Chalder fatigue questionnaire
Time frame: Pre-operative and postoperative day 1, day 3, day 5 and day 28
Health-related quality of life (EQ-5D)
Time frame: Pre-operative and postoperative day 28
Subjective sleep quality (PSQI)
Time frame: 3 days before surgery and postoperative day 28
Postoperative fatigue - Fatigue VAS scale
Time frame: Pre-operative and postoperative day 1, day 3, day 5 and day 28
Subjective sleep quality first night after surgery (RCSQ)
Time frame: Postoperative day 1
Postoperative delirium
Time frame: Postoperative day 1, day 3 and day 5
Postoperative cognitive impairment
Time frame: Pre-operative and postoperative day 28
Quality of Recovery (QoR)
Time frame: Pre-operative and postoperative day 3 and day 5
Postoperative muscle strength (upper extremity)
Time frame: Pre-operative and postoperative day 1, day 3 and day 5
Postoperative muscle strength (lower extremity)
Time frame: Pre-operative and postoperative day 3 and day 5
Sleeping EEG pattern
Time frame: First postoperative night
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexmedetomidine in people with Postoperative Fatigue and Postoperative Sleep Disturbances, run by Ziekenhuis Oost-Limburg at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Recovery (QoR) (time frame: Pre-operative and postoperative day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.