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Dexmedetomidine and Outcomes of Elderly Admitted to ICU After Surgery

NCT04204798 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1410

Last updated 2025-07-31

No results posted yet for this study

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

Interventions

DRUG

Dexmedetomidine

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.

DRUG

Placebo

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.

Sponsors & Collaborators

  • Peking University Third Hospital

    collaborator OTHER

  • Beijing Hospital

    collaborator OTHER_GOV

  • Peking University First Hospital

    lead OTHER

Principal Investigators

  • Dong-Xin Wang, MD, PhD · Peking University First Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-28
Primary Completion
2025-06-04
Completion
2026-06-04

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04204798 on ClinicalTrials.gov