Peking University First Hospital
Beijing, 100034, China
NCT Number: NCT03436472
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 5-year follow-up study is to evaluate whether prophylactic low-dose dexmedetomidine infusion can improve the 5-year outcomes in elderly patients recruited in the previous randomized controlled trial.
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Notify Me65 year–90 year
All sexes
Interventional
Not applicable
Beijing, 100034, China
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 5-year follow-up study is to evaluate whether prophylactic low-dose dexmedetomidine infusion during the early postoperative period can improve the 5-year outcomes in elderly patients recruited in the previous randomized controlled trial.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Patients were included if they met all of the following criteria:
Exclusion criteria
Patients were excluded if they met any of the following criteria:
low-dose dexmedetomidine infusion
Other names: dexmedetomidine hydrochloride
normal saline infusion
Other names: normal saline, 0.9% sodium chloride
Time frame: From the day of surgery until the end of the 5th year after surgery
Duration of 5-year survival after surgery
Time frame: At 6 months, 1 year, 2 years ,3 years, 4 years,and 5 years after surgery
Survival rates at different timepoints after surgery
Time frame: At the end of the 5th year after surgery
Cognitive function is assessed with Telephone Interview for Cognitive Status-Modified (TICS-M).
Time frame: At the end of the 5th year after surgery
Health related quality of life is assessed with World Health Organization Quality of Life-BREF (WHOQOL-BREF).
Time frame: At 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years after surgery
Survival rates at different time-points in the subgroup of patients after cancer or non-cancer surgery
Time frame: From the day of surgery until the end of the 5th year after surgery
Duration of survival in the subgroup of patients after cancer or non-cancer surgery
Time frame: At the end of the 5th year after surgery
Cognitive function is assessed with Telephone Interview for Cognitive Status-Modified (TICS-M)
Time frame: At the end of the 5th year after surgery
Health related quality of life is assessed with World Health Organization Quality of Life-BREF (WHOQOL-BREF).
Peking University First Hospital
Other
Impact of Dexmedetomidine on Long-term Outcome in Elderly Patients After Noncardiac Surgery: 5-year Follow-up of a Randomized Controlled Trial
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