The effect of nocturnal dexmedetomidine on postoperative sleep quality and fatigue after major surgery in elderly patients: DEXSLEEP study

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Ziekenhuis Oost Limburg

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Trial duration

3 Jun 2024 → ongoing

Decision date (initial)

2024-04-02

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

To evaluate the effect of the nocturnal administration of dexmedetomidine during the first night after surgery on postoperative sleep quality, thereby positively affecting postoperative outcomes such as postoperative fatigue and muscle weakness, subsequently enhancing recovery after surgery.

Secondary objectives 1

1. We hypothesize that the nocturnal administration of dexmedetomidine during the first night after surgery improves postoperative sleep quality and decreases the surgical endocrinological stress response, thereby improving postoperative outcomes such as postoperative fatigue and muscle weakness, subsequently enhancing recovery after surgery. Furthermore, we hypothesize that by improving postoperative sleep and decreasing the stress response, cognitive function will be less affected and markers of neuroinflammation will be diminished.

Conditions and MedDRA coding

Patients aged 60 years or older undergoing major surgery (thoracoscopic lung resection surgery)

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 2

1. Adult patients aged 60 years or older
2. Patients scheduled for thoracoscopic lung resection surgery

Exclusion criteria 3

1. Lack of informed consent or inability to give informed consent
2. 2nd- or higher degree atrioventricular block without pacemaker
3. urgent, not elective surgery

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. (Early) quality of recovery on day 1 following surgery compared to preoperative value, assessed by the quality of recovery score (QoR-15).

Secondary endpoints 17

1. The Quality of Recovery Score (QoR-15) will be used to assess the early postoperative health status of the patient, i.e. the quality of recovery
2. Postoperative muscle strength (lower extremity) and physical ability, assessed by the Timed Up and Go test (TUG)
3. Postoperative muscle function and decrease in strength (upper extremity) postoperatively will be assessed by comparing the handgrip strength of the dominant hand, measured by the CAMRY dynamometer
4. To assess general fatigue a fatigue questionnaire, the Chalder fatigue questionnaire, will be taken
5. To assess fatigue more in detail the fatigue VAS scale will be taken
6. The EQ-5D questionnaire will be taken to assess health-related quality of life
7. Electroencephalographic (EEG) readings will be conducted (in a subcohort of patients) during the first postoperative night (when administering study medication) via a compact/wearable medical device for recording brain activity
8. To evaluate each patient’s sleep-wake cycle, the sleep-wake timing will be evaluated with the Munich ChronoType Questionnaire (MCTQ), which will be used to calculate the baseline midpoint sleep and chronotype
9. To assess subjective sleep quality the Pittsburgh Sleep Quality Index (PSQI; a seven-item questionnaire consisting of 19 self-rated questions that assess sleep quality over the last month, each weighted equally on a 0-3 scale; higher scores indicate worse sleep quality) will be used
10. The evolution of sleep pre- and postoperatively will be evaluated with the Consensus Sleep Diary to have a more depth insight into the evolution of sleep pre- and postoperatively
11. The Richards-Campbell Sleep Questionnaire (RCSQ) will be taken to evaluate the subjective quality of the first night after surgery
12. To assess postoperative delirium the 3 minute confusion assessment method (3D-CAM) questionnaire will be done
13. To assess postoperative cognitive impairment the Telephone Interview for Cognitive Status (TICS-40) will be done
14. NRS pain scores 0-10
15. The occurrence of PONV
16. Markers of the inflammatory surgical response will be determined
17. Melatonin production will be monitored

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Ziekenhuis Oost Limburg

Sponsor organisation

Ziekenhuis Oost Limburg

Address

Synaps Park 1

City

Genk

Postcode

3600

Country

Belgium

Scientific contact point

Organisation

Ziekenhuis Oost Limburg

Contact name

Clinical Trial Unit

Public contact point

Organisation

Ziekenhuis Oost Limburg

Contact name

Clinical Trial Unit

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Application history

1 submissions — initial application plus substantial / non-substantial modifications