NCT04111926

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
619

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Oct 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 30, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 1, 2019

Completed
6 days until next milestone

Study Start

First participant enrolled

October 7, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
Last Updated

April 20, 2022

Status Verified

April 1, 2022

Enrollment Period

1.5 years

First QC Date

September 30, 2019

Last Update Submit

April 18, 2022

Conditions

Overall Survival

Keywords

Elderly patientsMajor non-cardiac surgeryDexmedetomidinelong-term survival

Outcome Measures

Primary Outcomes (1)

  • Overall survival within 3 years after surgery

    Overall survival within 3 years after surgery

    Up to 3 years after surgery.

Secondary Outcomes (4)

  • Recurrence-free survival within 3 years after surgery.

    Up to 3 years after surgery.

  • Cancer-specific survival within 3 years after surgery.

    Up to 3 years after surgery.

  • Rate of new-onset disease or hospital readmission within 3 years after surgery.

    Up to 3 years after surgery.

  • Quality of life in 3-year survivors.

    At 3 years after surgery.

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Control group

PLACEBO COMPARATOR

Volume-matched normal saline was administered in the same rate for the same duration as in the intervention group.

Drug: Placebo

Interventions

DexmedetomidineDRUG

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.

Also known as: Dexmedetomidine Hydrochloride
Intervention group
PlaceboDRUG

Volume-matched normal saline was administered in the same rate for the same duration as in the intervention group.

Also known as: Normal saline
Control group

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

Related Publications (9)

  • Abdel-Meguid ME. Dexmedetomidine as anesthetic adjunct for fast tracking and pain control in off-pump coronary artery bypass. Saudi J Anaesth. 2013 Jan;7(1):6-8. doi: 10.4103/1658-354X.109557.

    PMID: 23717223BACKGROUND

  • Jalonen J, Hynynen M, Kuitunen A, Heikkila H, Perttila J, Salmenpera M, Valtonen M, Aantaa R, Kallio A. Dexmedetomidine as an anesthetic adjunct in coronary artery bypass grafting. Anesthesiology. 1997 Feb;86(2):331-45. doi: 10.1097/00000542-199702000-00009.

    PMID: 9054252BACKGROUND

  • Li Y, Wang B, Zhang LL, He SF, Hu XW, Wong GT, Zhang Y. Dexmedetomidine Combined with General Anesthesia Provides Similar Intraoperative Stress Response Reduction When Compared with a Combined General and Epidural Anesthetic Technique. Anesth Analg. 2016 Apr;122(4):1202-10. doi: 10.1213/ANE.0000000000001165.

    PMID: 26991622BACKGROUND

  • Su X, Meng ZT, Wu XH, Cui F, Li HL, Wang DX, Zhu X, Zhu SN, Maze M, Ma D. Dexmedetomidine for prevention of delirium in elderly patients after non-cardiac surgery: a randomised, double-blind, placebo-controlled trial. Lancet. 2016 Oct 15;388(10054):1893-1902. doi: 10.1016/S0140-6736(16)30580-3. Epub 2016 Aug 16.

    PMID: 27542303BACKGROUND

  • Zhang DF, Su X, Meng ZT, Li HL, Wang DX, Xue-Ying Li, Maze M, Ma D. Impact of Dexmedetomidine on Long-term Outcomes After Noncardiac Surgery in Elderly: 3-Year Follow-up of a Randomized Controlled Trial. Ann Surg. 2019 Aug;270(2):356-363. doi: 10.1097/SLA.0000000000002801.

    PMID: 29742525BACKGROUND

  • Wang BJ, Li CJ, Hu J, Li HJ, Guo C, Wang ZH, Zhang QC, Mu DL, Wang DX. Impact of dexmedetomidine infusion during general anaesthesia on incidence of postoperative delirium in elderly patients after major non-cardiac surgery: study protocol of a randomised, double-blinded and placebo-controlled trial. BMJ Open. 2018 Apr 21;8(4):e019549. doi: 10.1136/bmjopen-2017-019549.

    PMID: 29680809BACKGROUND

  • Cata JP, Singh V, Lee BM, Villarreal J, Mehran JR, Yu J, Gottumukkala V, Lavon H, Ben-Eliyahu S. Intraoperative use of dexmedetomidine is associated with decreased overall survival after lung cancer surgery. J Anaesthesiol Clin Pharmacol. 2017 Jul-Sep;33(3):317-323. doi: 10.4103/joacp.JOACP_299_16.

    PMID: 29109628BACKGROUND

  • Gerresheim G, Schwemmer U. [Dexmedetomidine]. Anaesthesist. 2013 Aug;62(8):661-74. doi: 10.1007/s00101-013-2206-6. German.

    PMID: 23917892BACKGROUND

  • Xing MW, Li CJ, Guo C, Wang BJ, Mu DL, Wang DX. Effect of intraoperative dexmedetomidine on long-term survival in older patients after major noncardiac surgery: 3-year follow-up of a randomized trial. J Clin Anesth. 2023 Jun;86:111068. doi: 10.1016/j.jclinane.2023.111068. Epub 2023 Feb 1.

    PMID: 36736209DERIVED

MeSH Terms

Interventions

DexmedetomidineSaline Solution

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Dong-Xin Wang, MD, PhD

    Peking University First Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Chairman, Department of Anesthesiology and Critical Care Medicine

Study Record Dates

First Submitted

September 30, 2019

First Posted

October 1, 2019

Study Start

October 7, 2019

Primary Completion

April 1, 2021

Study Completion

April 1, 2021

Last Updated

April 20, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)