Dexmedetomidine and Outcomes of Elderly Admitted to ICU After Surgery

Not Applicable

Recruiting

• Conditions: Surgery; Overall Survival; Elderly; Intensive Care Unit; Dexmedetomidine
• Interventions: Drug: Placebo; Drug: Dexmedetomidine

• Registration Number: NCT04204798
• Lead Sponsor: Peking University First Hospital

Brief Summary

Sleep disorder and delirium are common problems in intensive care unit (ICU) patients, and may lead to poor prognosis. The investigators' previous study showed that nighttime infusion of low-dose dexmedetomidine improved the sleep quality and decreased the incidence of delirium in ICU patients after surgery. Long-term follow-up of these patients showed that low-dose dexmedetomidine also improved 2-year survival and the quality of life in 3-year survivors. The purpose of this study is to investigate the effect of low-dose dexmedetomidine on the long-term outcome of elderly patients admitted to the ICU after noncardiac surgery.

Detailed Description

Dexmedetomidine is a highly selective α2-adrenoceptor agonist with sedative, analgesic and anti-anxiety properties. Unlike other sedative agents, dexmedetomidine exerts its sedative effects through an endogenous sleep-promoting pathway, producing a state like non-rapid eye movement sleep. For mechanically ventilated patients, sedative-dose dexmedetomidine infusion at night maintains circadian rhythm, increases sleep efficiency, and improves sleep architecture. When used for sedation in mechanical ventilated patients, it reduces the incidence of delirium.

Dexmedetomidine may improve patient outcomes by improving sleep quality. A previous randomized trial found that, for elderly patients who were admitted to ICU after noncardiac surgery, nighttime infusion of low-dose dexmedetomidine significantly improves the sleep quality and decreases the incidence of postoperative delirium. A long-term follow-up of these patients showed that low-dose dexmedetomidine infusion significantly increased survival up to 2 years, and improved cognitive function and quality of life in 3-year survivors.

In the study mentioned above, dexmedetomidine was only infused during the night after surgery with a fixed dose. The investigators hypothesize that, for elderly admitted to ICU after surgery, nighttime infusion of individualized low-dose dexmedetomidine may improve long-term outcomes. This randomized controlled trial is designed to investigate the effect of low-dose dexmedetomidine on 1-year survival and the quality of life of 1-year survivors in elderly patients admitted to the ICU after surgery.

Study Timeline

• Study First Submitted: 2019-12-17
• Study First Submitted QC: 2019-12-18
• Study First Posted: 2019-12-19
• Study Start: 2020-08-28
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-17
• Last Update Posted: 2023-09-21
• Primary Completion: 2025-01
• Study Completion: 2025-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1410

Inclusion Criteria

• Age ≥65 years old;
• Admitted to intensive care unit (ICU) after noncardiac surgery;
• Expected to stay in ICU until the next morning. For those with endotracheal intubation, the expected duration of mechanical ventilation is <24 hours;
• Provide written informed consents.

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Exclusion Criteria

• Preoperative history of schizophrenia, epilepsy, Parkinsonism, or myasthenia gravis;
• Inability to communicate in the preoperative period (coma, profound dementia, or language barrier);
• Preoperative history of sleep apnea (previous diagnosis; or STOP-Bang score ≥3 with serum bicarbonate ≥ 28 mmol/L);
• Known sick sinus syndrome, severe sinus bradycardia (<50 beats per min [bpm]), or second degree or higher atrioventricular block without pacemaker;
• Hypotension (systolic blood pressure [SBP] <90 mmHg, mean arterial pressure [MAP] <70 mmHg, or a decrease of SBP >30% of baseline) or in a state of shock (vasopressors are required to maintain MAP ≥65 mmHg and serum lactate >2 mmol/L);
• Severe hepatic dysfunction (Child-Pugh class C), renal failure (requirement of renal replacement therapy), or expected survival <24 hours;
• Traumatic brain injury or neurosurgery;
• Presence of delirium before surgery (assessed with Confusion Assessment Method [CAM]/CAM-ICU);
• Undergoing treatment of dexmedetomidine or clonidine;
• Other conditions that are considered unsuitable for study participation.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo group	Placebo	Normal saline is infused for the same duration as in the dexmedetomidine group.
Dexmedetomidine group	Dexmedetomidine	Dexmedetomidine is infused from 4 pm to 8 am during ICU stay for no more than 3 days.

Primary Outcome Measures

Name	Time	Method
Overall survival after surgery	Up to 4 years after surgery	Overall survival after surgery

Secondary Outcome Measures

Name	Time	Method
Length of stay in the intensive care unit (ICU) stay after surgery	Up to 30 days after surgery	Length of ICU stay after surgery
Cancer-specific survival after surgery	Up to 4 year after surgery	Cancer-specific survival after surgery
Quality of life in 1-year survivors after surgery	At the end the 1st year after surgery	The quality of life is assessed with the World Health Organization Quality of Life Questionaire abbreviated version (WHOQOL-BREF, a 24-item questionnaire that provides assessments of the quality of life in physical, psychological, and social relationship, and environmental domains. For each domain, the score ranges from 0 to 100, with higher score indicating better function).
The incidence of organ injury within 5 days after surgery	Up to 5 days after surgery	Organ injury include delirium (assessed with Confusion Assessment Method/CAM for the Intensive Care Unit), acute kidney injury (assessed with KIDGO criteria), and myocardial injury (assessed with cardiac troponin I).
Length of stay in hospital after surgery	Up to 30 days after surgery	Length of stay in hospital after surgery
Incidence of postoperative complications within 30 days after surgery	Up to 30 days after surgery	Postoperative complications are defined as newly occured medical events that are harmful to patients' recovery and required interventional therapy.
Rate of all-cause 30-day mortality after surgery	Up to 30 days after surgery	All-cause 30-day mortality after surgery
Event-free survival after surgery	Up to 4 year after surgery	Event-free survival after surgery
Recurrence-free survival after surgery	Up to 4 year after surgery	Recurrence-free survival after surgery
Sleep quality at 30 days after surgery	At 30 days after surgery	The sleep quality is assessed with the Pittsburgh Sleep Quality Index Questionnaire (PSQI, score ranges from 0 to 21, with higher score indicating poorer sleep quality).

Trial Locations

Locations (1)

Peking University First Hospital; 🇨🇳 Beijing, Beijing, China