Dexmedetomidine and Long-term Outcome in Elderly Patients After Surgery

June 15, 2017 updated by: Dong-Xin Wang, Peking University First Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

700

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100034
        • Department of Anesthesiology and Critical Care Medicine, Peking University First Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: dexmedetomidine group
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.
Drug: dexmedetomidine
low-dose dexmedetomidine infusion
Other Names:
  • dexmedetomidine hydrochloride
Placebo Comparator: placebo group
Normal saline was infused in the same rate for the same duration as that in the placebo group.
Drug: placebo
normal saline infusion
Other Names:
  • normal saline or 0.9% sodium chloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of survival after surgery
Time Frame: From the day of surgery until the end of the 3rd year after surgery
Duration of survival after surgery
From the day of surgery until the end of the 3rd year after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival rates after surgery
Time Frame: At 6 months, 1 year, 2 years and 3 years after surgery
Survival rates at different timepoints after surgery
At 6 months, 1 year, 2 years and 3 years after surgery
Cognitive function in 3-year survivors after surgery
Time Frame: At the end of the 3rd year after surgery
Cognitive function is assessed with Telephone Interview for Cognitive Status-Modified (TICS-M).
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
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival rates in the subgroup of patients after cancer or non-cancer surgery
Time Frame: At 6 months, 1 year, 2 years and 3 years after 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
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 3rd year after 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
Cognitive function in the subgroup of 3-year survivors after cancer or non-cancer surgery
Time Frame: At the end of the 3rd year after surgery
Cognitive function is assessed with Telephone Interview for Cognitive Status-Modified (TICS-M).
At the end of the 3rd year after surgery
Health related quality of life in the subgroup of 3-year survivors after cancer or non-cancer surgery
Time Frame: At the end of the 3rd year 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University First Hospital

Collaborators

Peking University Third Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2011

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

June 1, 2017

Study Registration Dates

First Submitted

June 20, 2016

First Submitted That Met QC Criteria

June 20, 2016

First Posted (Estimate)

June 22, 2016

Study Record Updates

Last Update Posted (Actual)

June 16, 2017

Last Update Submitted That Met QC Criteria

June 15, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014[711]

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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