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Dexmedetomidine and 5-year Outcome in Elderly Patients After Surgery

Primary Purpose

Aged, Operative, Delirium

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
dexmedetomidine
placebo
Sponsored by
Peking University First Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Aged focused on measuring aged, operative, delirium, dexmedetomidine, long-term outcome

Eligibility Criteria

65 Years - 90 Years (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Peking University First Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

dexmedetomidine group

placebo group

Arm Description

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.

Normal saline was infused in the same rate for the same duration as that in the placebo group.

Outcomes

Primary Outcome Measures

Duration of 5-year survival after surgery
Duration of 5-year survival after surgery

Secondary Outcome Measures

Survival rates after surgery
Survival rates at different timepoints after surgery
Cognitive function in 5-year survivors after surgery
Cognitive function is assessed with Telephone Interview for Cognitive Status-Modified (TICS-M).
Health related quality of life in 5-year survivors after surgery
Health related quality of life is assessed with World Health Organization Quality of Life-BREF (WHOQOL-BREF).

Full Information

First Posted
February 12, 2018
Last Updated
June 20, 2019
Sponsor
Peking University First Hospital
Collaborators
Peking University Third Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03436472
Brief Title
Dexmedetomidine and 5-year Outcome in Elderly Patients After Surgery
Official Title
Impact of Dexmedetomidine on Long-term Outcome in Elderly Patients After Noncardiac Surgery: 5-year Follow-up of a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
January 8, 2019 (Actual)
Study Completion Date
April 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University First Hospital
Collaborators
Peking University Third Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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 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.
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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aged, Operative, Delirium, Dexmedetomidine, Mortality, Long-term Survivors
Keywords
aged, operative, delirium, dexmedetomidine, long-term outcome

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
700 (Actual)

8. Arms, Groups, and Interventions

Arm Title
dexmedetomidine group
Arm Type
Experimental
Arm Description
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.
Arm Title
placebo group
Arm Type
Placebo Comparator
Arm Description
Normal saline was infused in the same rate for the same duration as that in the placebo group.
Intervention Type
Drug
Intervention Name(s)
dexmedetomidine
Other Intervention Name(s)
dexmedetomidine hydrochloride
Intervention Description
low-dose dexmedetomidine infusion
Intervention Type
Drug
Intervention Name(s)
placebo
Other Intervention Name(s)
normal saline, 0.9% sodium chloride
Intervention Description
normal saline infusion
Primary Outcome Measure Information:
Title
Duration of 5-year survival after surgery
Description
Duration of 5-year survival after surgery
Time Frame
From the day of surgery until the end of the 5th year after surgery
Secondary Outcome Measure Information:
Title
Survival rates after surgery
Description
Survival rates at different timepoints after surgery
Time Frame
At 6 months, 1 year, 2 years ,3 years, 4 years,and 5 years after surgery
Title
Cognitive function in 5-year survivors after surgery
Description
Cognitive function is assessed with Telephone Interview for Cognitive Status-Modified (TICS-M).
Time Frame
At the end of the 5th year after surgery
Title
Health related quality of life in 5-year survivors after surgery
Description
Health related quality of life is assessed with World Health Organization Quality of Life-BREF (WHOQOL-BREF).
Time Frame
At the end of the 5th year after surgery
Other Pre-specified Outcome Measures:
Title
Survival rates in the subgroup of patients after cancer or non-cancer surgery
Description
Survival rates at different time-points 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
Title
Duration of survival in the subgroup of patients after cancer or non-cancer surgery
Description
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
Title
Cognitive function in the subgroup of 5-year survivors after cancer or non-cancer surgery
Description
Cognitive function is assessed with Telephone Interview for Cognitive Status-Modified (TICS-M)
Time Frame
At the end of the 5th year after surgery
Title
Health related quality of life in the subgroup of 5-year survivors after cancer or non-cancer surgery
Description
Health related quality of life is assessed with World Health Organization Quality of Life-BREF (WHOQOL-BREF).
Time Frame
At the end of the 5th year after surgery

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dong-Xin Wang, MD,PhD
Organizational Affiliation
Peking University First Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University First Hospital
City
Beijing
ZIP/Postal Code
100034
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data will be provided on request.
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Dexmedetomidine and 5-year Outcome in Elderly Patients After Surgery

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