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

NCT ID: NCT06480539

Last Updated: 2026-01-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-06
• Study Completion Date: 2026-04-30

Brief 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.

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.

Conditions

Postoperative Fatigue; Postoperative Sleep Disturbances; Surgical Stress Response

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

The comparator is a placebo, namely pure saline (NaCl 0.9%), which will be administered following the same regimen as the intervention.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

The comparator is a placebo, namely pure saline (NaCl 0.9%), which will be administered following the same regimen as the intervention.

Dexmedetomidine

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.

Group Type: ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type: DRUG

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.

Interventions

Placebo

The comparator is a placebo, namely pure saline (NaCl 0.9%), which will be administered following the same regimen as the intervention.

Intervention Type: DRUG

Dexmedetomidine

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• aged 60 years or older;
• scheduled for thoracoscopic lung surgery.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ziekenhuis Oost-Limburg

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ziekenhuis Oost-Limburg

Genk, Limburg, Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Steven Thiessen

Role: CONTACT

steven.thiessen@zol.be

3289325294

Facility Contacts

Steven Thiessen

Role: primary

steven.thiessen@zol.be

3289325294

Other Identifiers

Z-2023104

Identifier Type: -

Identifier Source: org_study_id