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NCT Number: NCT03436472

Dexmedetomidine and 5-year Outcome in Elderly Patients After Surgery

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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Key information

Age range

65 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking University First Hospital

Beijing, 100034, China

About this study

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.

Who can participate

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:

  • Age of 65 years or older;
  • Underwent elective noncardiac surgery under general anesthesia;
  • Admitted to ICU after surgery.

Exclusion criteria

Patients were excluded if they met any of the following criteria:

  • Preoperative history of schizophrenia, epilepsy, Parkinsonism or myasthenia gravis;
  • Inability to communicate in the preoperative period (because of coma, profound dementia or language barrier);
  • Brain injury or neurosurgery;
  • 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;
  • Serious hepatic dysfunction (Child-Pugh class C);
  • Serious renal dysfunction (undergoing dialysis before surgery); or
  • Unlikely to survive for more than 24 hours.

Treatment and study plan

Dexmedetomidine

Drug

low-dose dexmedetomidine infusion

Other names: dexmedetomidine hydrochloride

Placebo

Drug

normal saline infusion

Other names: normal saline, 0.9% sodium chloride

Primary outcomes

  1. Duration of 5-year survival after surgery

    Time frame: From the day of surgery until the end of the 5th year after surgery

    Duration of 5-year survival after surgery

Secondary outcomes

  1. Survival rates 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

  2. Cognitive function in 5-year survivors 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).

  3. Health related quality of life in 5-year survivors after surgery

    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).

Other outcomes

  1. Survival rates in the subgroup of patients after cancer or non-cancer surgery

    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

  2. Duration of survival 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

  3. Cognitive function in the subgroup of 5-year survivors 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)

  4. Health related quality of life in the subgroup of 5-year survivors after cancer or non-cancer surgery

    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).

Sponsors and collaborators

Lead sponsor

Peking University First Hospital

Other

Collaborators

  • Peking University Third Hospital

Registry information

Official study title

Impact of Dexmedetomidine on Long-term Outcome in Elderly Patients After Noncardiac Surgery: 5-year Follow-up of a Randomized Controlled Trial

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Feb 19, 2018
Registry last updated
Jun 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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