Dexmedetomidine and Outcomes of Elderly Admitted to ICU After Surgery

NCT04204798 | Active Not Recruiting DMC

• 1 other identifier: 2019-226
• Study Type: interventional
• Target: 1,410
• Locations: 1 country
• Sites: 1

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.

Conditions

Elderly; Surgery; Intensive Care Unit; Dexmedetomidine; Overall Survival

Keywords

Elderly; Surgery; Intensive Care Unit; Dexmedetomidine; Overall survival

Outcome Measures

Primary Outcomes (1)

• Overall survival after surgery

  Overall survival after surgery

  Up to 4 years after surgery

Secondary Outcomes (10)

• The incidence of organ injury within 5 days after surgery

  Up to 5 days after surgery

• Length of stay in the intensive care unit (ICU) stay after surgery

  Up to 30 days after surgery

• Length of stay in hospital after surgery

  Up to 30 days after surgery

• Incidence of postoperative complications within 30 days after surgery

  Up to 30 days after surgery

• Rate of all-cause 30-day mortality after surgery

  Up to 30 days after surgery

Other Outcomes (6)

• Pain severity within 5 days after surgery: Numeric Rating Scale

  Up to 5 days after surgery.

• Subjective sleep quality within 5 days after surgery: Numeric Rating Scale

  Assessed in the morning on the 1st, 2nd, 3rd, 4th, and 5th day after surgery

• Overall survival after surgery in cancer patients

  Up to 4 year after surgery

Study Arms (2)

Dexmedetomidine group

EXPERIMENTAL

Dexmedetomidine is infused from 4 pm to 8 am during ICU stay for no more than 3 days.

Drug: Dexmedetomidine

Placebo group

PLACEBO COMPARATOR

Normal saline is infused for the same duration as in the dexmedetomidine group.

Drug: Placebo

Interventions

Dexmedetomidine DRUG

1. Dexmedetomidine is infused from 4 pm to 8 am during ICU stay for no more than 3 days. 2. For non-intubated patients, the infusion rate is adjusted to reach a Richmond Agitation-Sedation Scale (RASS) of -1, or a maximal rate of 0.2 microgram/kg/h, or the occurrence of any adverse events. 3. For intubated patients, the infusion rate is adjusted to reach a RASS of -1, or a maximal rate of 0.7 microgram/kg/h, or the occurrence of any adverse events.

Dexmedetomidine group

Placebo DRUG

1. Normal saline is infused in the same rate for the same duration as in the dexmedetomidine group. 2. Propofol sedation is administered when considered necessary.

Also known as: Normal saline

Placebo group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University First Hospital: lead
• Peking University Third Hospital: collaborator
• Beijing Hospital: collaborator

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

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MeSH Terms

Interventions

Dexmedetomidine; Saline Solution

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Dong-Xin Wang, MD, PhD

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chairman, Department of Anesthesiology and Critical Care Medicine

Study Record Dates

• First Submitted: December 17, 2019
• First Posted: December 19, 2019
• Study Start: August 28, 2020
• Primary Completion: June 4, 2025
• Study Completion (Estimated): June 4, 2026
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)