Dexmedetomidine and Long-term Outcome in Elderly Patients After Surgery

Delirium Clinical Trial

Official title:

Impact of Dexmedetomidine on Long-term Outcome in Elderly Patients After Noncardiac Surgery: 3-year Follow-up of a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02809937
• Other study ID #: 2014[711]
• Status: Completed
• Phase: Phase 4
• First received: June 20, 2016
• Last updated: June 15, 2017
• Start date: May 2011
• Est. completion date: June 2017

Study information

• Verified date: June 2017
• Source: Peking University First Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 700
• Est. completion date: June 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aged
• Delirium
• Dexmedetomidine
• Long-term Survivors
• Mortality
• Surgical Procedures, Operative

Intervention

Drug:
• dexmedetomidine
low-dose dexmedetomidine infusion
• placebo
normal saline infusion

Locations

Country	Name	City	State
China	Department of Anesthesiology and Critical Care Medicine, Peking University First Hospital	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Peking University First Hospital	Peking University Third Hospital

Country where clinical trial is conducted

China, 

References & Publications (33)

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* Note: There are 33 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Survival rates in the subgroup of patients after cancer or non-cancer surgery	Survival rates at different timepoints in the subgroup of patients after cancer or non-cancer surgery	At 6 months, 1 year, 2 years and 3 years after surgery
Other	Duration of survival in the subgroup of patients after cancer or non-cancer surgery	Duration of survival in the subgroup of patients after cancer or non-cancer surgery	From the day of surgery until the end of the 3rd year after surgery
Other	Cognitive function in the subgroup of 3-year survivors after cancer or non-cancer surgery	Cognitive function is assessed with Telephone Interview for Cognitive Status-Modified (TICS-M).	At the end of the 3rd year after surgery
Other	Health related quality of life in the subgroup of 3-year survivors after cancer or non-cancer surgery	Health related quality of life is assessed with World Health Organization Quality of Life-BREF (WHOQOL-BREF).	At the end of the 3rd year after surgery
Primary	Duration of survival after surgery	Duration of survival after surgery	From the day of surgery until the end of the 3rd year after surgery
Secondary	Survival rates after surgery	Survival rates at different timepoints after surgery	At 6 months, 1 year, 2 years and 3 years after surgery
Secondary	Cognitive function in 3-year survivors after surgery	Cognitive function is assessed with Telephone Interview for Cognitive Status-Modified (TICS-M).	At the end of the 3rd year after surgery
Secondary	Health related quality of life in 3-year survivors after surgery	Health related quality of life is assessed with World Health Organization Quality of Life-BREF (WHOQOL-BREF).	At the end of the 3rd year after surgery