The Effect of Nocturnal Dexmedetomidine on Postoperative Sleep Quality and Fatigue After Major Surgery in Elderly Patients: DEXSLEEP Study

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age60+
SponsorZiekenhuis Oost-Limburg

About this trial

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.

Eligibility criteria

Qualifiers

aged 60 years or older;

scheduled for thoracoscopic lung surgery.

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Placebo
  • Dexmedetomidine

Treatment groups

102 Participants
are divided into 2 treatment groups

Sponsors and collaborators