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Intraoperative Dexmedetomidine and Long-term Outcomes in Elderly After Major Surgery

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ClinicalTrials.gov Identifier: NCT04111926
Recruitment Status : Active, not recruiting
First Posted : October 1, 2019
Last Update Posted : December 11, 2019
Sponsor:
Information provided by (Responsible Party):
Dong-Xin Wang, Peking University First Hospital

Brief Summary:
This is a 3-year follow-up of patients enrolled in a previous randomized controlled trial which showed that intraoperative dexmedetomidine reduced delirium in elderly patients after major non-cardiac surgery. The purpose of this study is to clarify the effects of intraoperative dexmedetomidine on long-term outcomes of these patients.

Condition or disease Intervention/treatment Phase
Overall Survival Drug: Dexmedetomidine Drug: Placebo Phase 4

Detailed Description:

Dexmedetomidine is a highly selective α-2-receptor agonist with sedative, analgesic and anxiolytic effects. When used as an supplement during general anaesthesia, it reduces the consumption of the anaesthetics and relieves surgery-related stress response and inflammation. In a recent randomized ontrolled trial of the applicants, 620 elderly patients who underwent major non-cardiac surgery were randomized to receive dexmedetomidine or normal saline during general anesthesia. The results showed that use of dexmedetomidine reduced delirium (5.5% [17/309] with dexmedetomidine vs. 10.2% [32/310] with placebo, P=0.026) and 30-day non-delirium complications (9.4% [60/309] with dexmedetomidine vs. 26.1% [81/310] with placebo, P=0.047) after surgery.

The effects of intraoperative dexmedetomidine on long-term outcomes after surgery remains unclear. In another study of the applicants, use of low-dose dexemeditomidine in ICU patients after surgery increased survival up to 2 years and improve quality of life in 3-year survivors. On the contrary, it was reported in a retrospective study that intraoperative use of dexmedetomidine was associated with shortened overall survival in patients after lung cancer surgery. Therefore, it is urgent to clarify the impact of intraoperative dexemeditomidine on long-term outcomes of patients undergoing major surgery, especially those undergoing cancer surgery.

This study is a 3-year follow-up of patients who were enrolled in a randomzied controlled trial of the applicants in order to clarify the effects of intraoperative dexmedetomidine on long-term outcomes after surgery.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 619 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Impact of Intraoperative Dexmedetomidine on Long-term Outcomes in Elderly Patients After Major Non-cardiac Surgery: 3-year Follow-up of a Randomised Controlled Trial
Actual Study Start Date : October 7, 2019
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention group
A loading dose of dexmedetomidine (0.6 μg/kg) was administered during a 10-minute period before anaesthesia induction, followed by a continuous infusion at a rate of 0.5 μg/kg/hr till 1 hour before the end of surgery.
Drug: Dexmedetomidine
A loading dose of dexmedetomidine (0.6 μg/kg) was administered during a 10-minute period before anaesthesia induction, followed by a continuous infusion at a rate of 0.5 μg/kg/hr till 1 hour before the end of surgery.
Other Name: Dexmedetomidine Hydrochloride

Placebo Comparator: Control group
Volume-matched normal saline was administered in the same rate for the same duration as in the intervention group.
Drug: Placebo
Volume-matched normal saline was administered in the same rate for the same duration as in the intervention group.
Other Name: Normal saline




Primary Outcome Measures :
  1. Overall survival within 3 years after surgery [ Time Frame: Up to 3 years after surgery. ]
    Overall survival within 3 years after surgery


Secondary Outcome Measures :
  1. Recurrence-free survival within 3 years after surgery. [ Time Frame: Up to 3 years after surgery. ]
    Recurrence-free survival within 3 years after surgery.

  2. Cancer-specific survival within 3 years after surgery. [ Time Frame: Up to 3 years after surgery. ]
    Cancer-specific survival within 3 years after surgery.

  3. Rate of new-onset disease or hospital readmission within 3 years after surgery. [ Time Frame: Up to 3 years after surgery. ]
    Rate of new-onset disease or hospital readmission within 3 years after surgery.

  4. Quality of life in 3-year survivors. [ Time Frame: At 3 years after surgery. ]
    Quality of life is assessed with the World Health Organization Quality of Life-Brief Version. It assesses the quality of life at 4 domains, i.e., physical, psychological, social relationships, and environment. The score of each domain ranges from 0 to 100, with higher score indicating better quality of life.



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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Elderly patients (age ≥60 years);
  • Scheduled to undergo elective major non-cardiac surgery with expected duration ≥2 hours under general anaesthesia.

Exclusion Criteria:

  • Do not provide written informed consent;
  • Previous history of schizophrenia, epilepsy or Parkinson's disease;
  • Visual, hearing, language or other barriers which impede communication and preoperative delirium assessment;
  • History of traumatic brain injury;
  • Severe bradycardia (heart rate <40 beats per minutes), sick sinus syndrome, or atrioventricular block of degree 2 or above without pacemaker;
  • Severe hepatic dysfunction (Child-Pugh grade C);
  • Renal failure (requirement of renal replacement therapy);
  • Neurosurgery.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04111926


Locations
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China, Beijing
Peking University First Hospital
Beijing, Beijing, China, 100034
Sponsors and Collaborators
Peking University First Hospital
Investigators
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Principal Investigator: Dong-Xin Wang, MD, PhD Peking University First Hospital

Publications:

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Responsible Party: Dong-Xin Wang, Professor and Chairman, Department of Anesthesiology and Critical Care Medicine, Peking University First Hospital
ClinicalTrials.gov Identifier: NCT04111926    
Other Study ID Numbers: 2019-0927
First Posted: October 1, 2019    Key Record Dates
Last Update Posted: December 11, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dong-Xin Wang, Peking University First Hospital:
Elderly patients
Major non-cardiac surgery
Dexmedetomidine
long-term survival
Additional relevant MeSH terms:
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Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action