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

NCT06480539 | Recruiting Phase 4

• 1 other identifier: Z-2023104
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Sleep Disturbances; Surgical Stress Response; Postoperative Fatigue

Keywords

Major surgery; Enhanced Recovery After Surgery (ERAS); Elderly patients; Quality of recovery; Postoperative fatigue; Postoperative muscle weakness; Postoperative sleep disturbances; Dexmedetomidine

Outcome Measures

Primary Outcomes (1)

• 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.

  Pre-operative and postoperative day 1

Secondary Outcomes (13)

• Sleep-wake cycle (MCTQ)

  3 days before surgery

• Sleep pattern (CSD)

  10 consecutive nights, starting 3 days before surgery

• Postoperative fatigue - Chalder fatigue questionnaire

  Pre-operative and postoperative day 1, day 3, day 5 and day 28

• Health-related quality of life (EQ-5D)

  Pre-operative and postoperative day 28

• Subjective sleep quality (PSQI)

  3 days before surgery and postoperative day 28

Study Arms (2)

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.

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.

Drug: Dexmedetomidine

Interventions

Placebo DRUG

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

Placebo

Dexmedetomidine 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.

Dexmedetomidine

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ziekenhuis Oost-Limburg: lead

Study Sites (1)

Ziekenhuis Oost-Limburg

Genk, Limburg, 3600, Belgium

RECRUITING

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Steven Thiessen

CONTACT

3289325294; steven.thiessen@zol.be

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2024
• First Posted: June 28, 2024
• Study Start: June 6, 2024
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: April 8, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)