Overview

This trial is active, not recruiting.

Conditions aged, surgical procedures, operative, delirium, dexmedetomidine, mortality, long-term survivors
Treatments dexmedetomidine, placebo
Phase phase 4
Sponsor Peking University First Hospital
Collaborator Peking University Third Hospital
Start date May 2011
End date December 2016
Trial size 700 participants
Trial identifier NCT02809937, 2014[711]

Summary

Delirium is a frequent postoperative complication. Its occurrence is associated with worse long-term outcomes. In a previous randomized controlled trial, prophylactic low-dose dexmedetomidine infusion during the early postoperative period decreased the incidence of delirium in elderly patients after surgery. The purpose of this 3-year follow-up study is to evaluate whether prophylactic low-dose dexmedetomidine infusion can improve the 3-year outcome in elderly patients recruited in the previous randomized controlled trial.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose prevention
Arm
(Experimental)
For patients who were not intubated, dexmedetomidine was infused at a rate of 0.1 microgram/kg per hour from study recruitment on the day of surgery until 8:00 am on the first day after surgery. For patients who were intubated and mechanically ventilated, dexmedetomidine infusion was started after the Richmond Agitation Sedation Scale was -2 or higher after intensive care unit admission until 8:00 am on the first day after surgery.
dexmedetomidine dexmedetomidine hydrochloride
low-dose dexmedetomidine infusion
(Placebo Comparator)
Normal saline was infused in the same rate for the same duration as that in the placebo group.
placebo normal saline or 0.9% sodium chloride
normal saline infusion

Primary Outcomes

Measure
3-year survival rate after surgery
time frame: At the end of the 3rd year after surgery

Secondary Outcomes

Measure
Duration of survival after surgery
time frame: From the day of surgery until the end of the 3rd year after surgery
Cognitive function in 3-year survivors after surgery
time frame: At the end of the 3rd year after surgery
Health related quality of life in 3-year survivors after surgery
time frame: At the end of the 3rd year after surgery

Eligibility Criteria

Male or female participants at least 65 years old.

Inclusion Criteria: Patients were included if they met all of the following criteria: 1. Age of 65 years or older; 2. Underwent elective noncardiac surgery under general anesthesia; 3. Admitted to ICU after surgery. Exclusion Criteria: Patients were excluded if they met any of the following criteria: 1. Preoperative history of schizophrenia, epilepsy, Parkinsonism or myasthenia gravis; 2. Inability to communicate in the preoperative period (because of coma, profound dementia or language barrier); 3. Brain injury or neurosurgery; 4. Preoperative left ventricular ejection fraction < 30%, sick sinus syndrome, severe sinus bradycardia (< 50 beats per minute), or second-degree or greater atrioventricular block without pacemaker; 5. Serious hepatic dysfunction (Child-Pugh class C); 6. Serious renal dysfunction (undergoing dialysis before surgery); or 7. Unlikely to survive for more than 24 hours.

Additional Information

Official title Impact of Dexmedetomidine on Long-term Outcome in Elderly Patients After Noncardiac Surgery: 3-year Follow-up of a Randomized Controlled Trial
Principal investigator Dong-Xin Wang, MD,PhD
Description Delirium is a frequent postoperative complication; a systematic review revealed that postoperative delirium occurs in 36.8% of surgical patients, and its prevalence increases with age. The occurrence of delirium is associated with worse long-term outcomes including worse functional recovery, decline in cognitive function, and increased mortality rate. Surgical stress, pain, and sleep disturbances are important factors leading to postoperative delirium in the elderly. Dexmedetomidine is a highly selective alpha-2 adrenoreceptor agonist that provides anti-anxiety, sedation, and modest analgesia with minimal respiratory depression. For mechanically ventilated intensive care unit (ICU) patients, dexmedetomidine sedation improves the quality of sleep, decreases the incidence of delirium, and shortens the duration of ICU stay. For patients undergoing surgery, perioperative dexmedetomidine relieves the severity of stress response, decreases the requirement of anesthetics, and improves postoperative analgesia. In the previous stage of the current study, 700 elderly patients who were admitted to the ICU after noncardiac surgery were recruited and randomized into two groups (dexmedetomidine group and placebo [normal saline] group). The results showed that prophylactic low-dose dexmedetomidine infusion during the early postoperative period ameliorated the subjective sleep quality and decreased the incidence of delirium (22.6% [79/350] with placebo vs. 9.1% [32/350] with dexmedetomidine; Odds Ratio 0.35, 95% Confidence Interval 0.22 to 0.54; p < 0.0001). The investigators hypothesize that low-dose dexmedetomidine infusion may also improve long-term outcome in this patient population. The purpose of this 3-year follow-up study is to evaluate whether prophylactic low-dose dexmedetomidine infusion during the early postoperative period can improve the 3-year outcome in elderly patients recruited in the previous randomized controlled trial.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Peking University First Hospital.