NCT03335579

Brief Summary

The relationship between anesthetic medication and postoperative major cardiac and cerebral complications will be studied using logistic regression model.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
50,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2016

Shorter than P25 for all trials

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

Study Start

First participant enrolled

December 31, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2017

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

October 30, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 7, 2017

Completed
Last Updated

November 7, 2017

Status Verified

November 1, 2017

Enrollment Period

7 months

First QC Date

October 30, 2017

Last Update Submit

November 3, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Major cardiac complication

    major cardiac event

    90 days after surgery

Study Arms (2)

non-MACE

patients without major postoperative cardiac or cerebral complications

Combination Product: inhalation or propofol ,epidural or general anesthesia, remifentanil or sufentanil

MACE

patients with major postoperative cardiac or cerebral complications

Combination Product: inhalation or propofol ,epidural or general anesthesia, remifentanil or sufentanil

Interventions

Different combination of opioids and anesthetics

MACEnon-MACE

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients for non-cardiac surgery under general anesthesia

You may qualify if:

  • non-cardiac surgery, with age\> = 18 years old, ASA grade I-IV, under general anesthesia

You may not qualify if:

  • non-general anesthesia, without the use of target-controlled infusion of remifentanil or sufentanil, absence of intraoperative or perioperative information.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Herling SF, Dreijer B, Wrist Lam G, Thomsen T, Moller AM. Total intravenous anaesthesia versus inhalational anaesthesia for adults undergoing transabdominal robotic assisted laparoscopic surgery. Cochrane Database Syst Rev. 2017 Apr 4;4(4):CD011387. doi: 10.1002/14651858.CD011387.pub2.

    PMID: 28374886BACKGROUND
  • Flier S, Post J, Concepcion AN, Kappen TH, Kalkman CJ, Buhre WF. Influence of propofol-opioid vs isoflurane-opioid anaesthesia on postoperative troponin release in patients undergoing coronary artery bypass grafting. Br J Anaesth. 2010 Aug;105(2):122-30. doi: 10.1093/bja/aeq111. Epub 2010 Jun 23.

    PMID: 20573633BACKGROUND
  • Min JJ, Kim G, Lee JH, Hong KY, Kim WS, Lee YT. Does the Type of Anesthetic Technique Affect In-Hospital and One-Year Outcomes after Off-Pump Coronary Arterial Bypass Surgery? PLoS One. 2016 Apr 7;11(4):e0152060. doi: 10.1371/journal.pone.0152060. eCollection 2016.

    PMID: 27054364BACKGROUND
  • Guclu CY, Unver S, Aydinli B, Kazanci D, Dilber E, Ozgok A. The effect of sevoflurane vs. TIVA on cerebral oxygen saturation during cardiopulmonary bypass--randomized trial. Adv Clin Exp Med. 2014 Nov-Dec;23(6):919-24. doi: 10.17219/acem/37339.

    PMID: 25618118BACKGROUND

MeSH Terms

Interventions

InhalationAnesthesia, GeneralRemifentanilSufentanil

Intervention Hierarchy (Ancestors)

Respiratory MechanicsRespirationRespiratory Physiological PhenomenaCirculatory and Respiratory Physiological PhenomenaAnesthesiaAnesthesia and AnalgesiaPropionatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFentanyl

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 30, 2017

First Posted

November 7, 2017

Study Start

December 31, 2016

Primary Completion

August 1, 2017

Study Completion

October 10, 2017

Last Updated

November 7, 2017

Record last verified: 2017-11