Intranasal dexmedetomidine on the effect of postoperative sleep quality for patients undergoing on-pump cardiac surgery: a prospective double-blinded randomized control study protocol

Sleep disturbances are highly prevalent in the perioperative period and are associated with poor recovery outcomes. This is particularly relevant for cardiac surgery patients, among whom sleep architecture disorders are common postoperative complications. Dexmedetomidine, a selective α2-adrenergic receptor agonist, has shown promise in improving sleep quality by promoting non-rapid eye movement (NREM) sleep. However, the efficacy of its non-invasive, intranasal administration for postoperative sleep management remains underexplored. In this prospective randomized study, adult patients undergoing cardiac surgery will be enrolled. Participants will be randomly assigned to receive either intranasal dexmedetomidine or an identical placebo on postoperative days 1–4. The primary outcome was the subjective sleep quality assessed using the Richards-Campbell Sleep Questionnaire (RCSQ) on the second postoperative morning. Secondary outcomes included objective sleep parameters measured by sleep monitors, incidence of delirium, pain scores, patient satisfaction, postoperative ICU length of stay, postoperative in-hospital all-cause mortality, sleep quality, and cognitive function after discharge. Our study will aim to assess the impact of intranasal administration of dexmedetomidine on the effect of sleep disturbance in patients undergoing on-pump elective cardiac surgery. If intranasal dexmedetomidine proves to be effective, it will be a promising strategy for enhancing recovery and may reduce associated neurological complications. ChiCTR2500109422. Registered on September 18, 2025.

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Journal
Trials
Published
2026-09-09
DOI
https://doi.org/10.1186/s13063-026-09996-7
Primary Topic
Intensive Care Unit Cognitive Disorders
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article
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article

Intranasal dexmedetomidine on the effect of postoperative sleep quality for patients undergoing on-pump cardiac surgery: a prospective double-blinded randomized control study protocol

Dongmei Li, Tang Hong, Xuetao Jiang, Zonghong Long et al.
Trials
Intensive Care Unit Cognitive Disorders
article

Intranasal dexmedetomidine on the effect of postoperative sleep quality for patients undergoing on-pump cardiac surgery: a prospective double-blinded randomized control study protocol

Dongmei Li, Tang Hong, Xuetao Jiang, Zonghong Long, Jinping Ding, Ling TANG, Guiying Yang, Dashuang Xi, Ming Yang
article en

Abstract

Sleep disturbances are highly prevalent in the perioperative period and are associated with poor recovery outcomes. This is particularly relevant for cardiac surgery patients, among whom sleep architecture disorders are common postoperative complications. Dexmedetomidine, a selective α2-adrenergic receptor agonist, has shown promise in improving sleep quality by promoting non-rapid eye movement (NREM) sleep. However, the efficacy of its non-invasive, intranasal administration for postoperative sleep management remains underexplored. In this prospective randomized study, adult patients undergoing cardiac surgery will be enrolled. Participants will be randomly assigned to receive either intranasal dexmedetomidine or an identical placebo on postoperative days 1–4. The primary outcome was the subjective sleep quality assessed using the Richards-Campbell Sleep Questionnaire (RCSQ) on the second postoperative morning. Secondary outcomes included objective sleep parameters measured by sleep monitors, incidence of delirium, pain scores, patient satisfaction, postoperative ICU length of stay, postoperative in-hospital all-cause mortality, sleep quality, and cognitive function after discharge. Our study will aim to assess the impact of intranasal administration of dexmedetomidine on the effect of sleep disturbance in patients undergoing on-pump elective cardiac surgery. If intranasal dexmedetomidine proves to be effective, it will be a promising strategy for enhancing recovery and may reduce associated neurological complications. ChiCTR2500109422. Registered on September 18, 2025.

Trials
Army Medical University (CN), Xinqiao Hospital (CN)
Good health and well-being
Openalex Percentile: Top 9%
Intensive Care Unit Cognitive Disorders
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