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Completed

NCT Number: NCT02712528

Recovery Profiles of Remifentanil-based Regimen for Cardiac Surgery

Backgrounds: Monitoring of Bispectral index (BIS) has been regarded as useful to determine the degree of intraoperative hypnosis. Major factors of postoperative recovery after cardiac surgery include patient's recovery in cognitive function from the postoperative residual effects of anesthetics, such as opioids and sedatives, administered during intraoperative period. Therefore employing anesthetic regimens which can provide earlier recovery in cognitive function would be beneficial in facilitating fast-track cardiac surgery with earlier postoperative extubation and discharge from the intensive care unit (ICU).

Previous investigations suggested efficacy of BIS in evaluating the degree of postoperative hypnosis in the ICU.

The present study compares the time for reaching BIS greater than 80 after using 2 different anesthesia regimens for cardiac surgery, remifentanil-based regimen and sevoflurane-sufentanil balanced regimen.

Analyzing the changes immediately after cardiac surgery would be useful to determine the degree of patient's postoperative emergence.

Materials and Methods:

During study period, patients undergoing elective cardiac surgery in Konkuk University Medical Center are randomly assigned to get remifentanil-based regimen consisting of remifentanil 0.75 mcg/kg/min and supplemental propofol for maintaining BIS 40-60 (Group R) or sevoflurane (end-tidal 1.2-2.8 vol%) and sufentanil (0.015 mcg/kg/min) balanced regimen in Group S.

All patients get intravenous patient controlled anesthesia consisting of alfentanyl and ondansetron after surgery. Supplemental remifentanil 0.25-0.3 mcg/kg/min is administered during postoperative 2 hours in Group R.

As a primary objective, inter-group difference in the time for achieving BIS greater than 80 is determined.

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Key information

Conditions

Age range

19 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Konkuk University Medical Center

Seoul, 05030, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients undergoing elective coronary artery bypass surgery

Exclusion criteria

  • combined valve surgery
  • preoperative intraaortic balloon pumping
  • preoperative low cardiac output syndrome
  • chronic obstructive pulmonary disease

Treatment and study plan

remifentanil-based

Drug

sevoflurane-sufentanil balanced

Drug

Primary outcomes

  1. Time to reach BIS > 80

    Time frame: 1 minute

    Time to reach BIS > 80 after surgery

Secondary outcomes

  1. Extubation time

    Time frame: 1 minute

    Time to perform extubation after surgery

Sponsors and collaborators

Lead sponsor

Konkuk University Medical Center

Other

Registry information

Official study title

Recovery Profiles of Remifentanil-based vs. Sevoflurane-sufentanil Combined Regimen for Cardiac Surgery

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Mar 18, 2016
Registry last updated
Dec 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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