Recovery Profiles of Remifentanil-based Regimen for Cardiac Surgery

NCT02712528 | Completed Phase 4

• 1 other identifier: KUH1160080
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cardiac Surgery

Keywords

bispectral index; extubation; recovery; remifentanil

Outcome Measures

Primary Outcomes (1)

• Time to reach BIS > 80

  Time to reach BIS \> 80 after surgery

  1 minute

Secondary Outcomes (1)

• Extubation time

  1 minute

Study Arms (2)

remifentanil-based

ACTIVE COMPARATOR

remifentanil-based regimen consisting of remifentanil 0.75 mcg/kg/min and supplemental propofol for maintaining BIS 40-60

Drug: remifentanil-based

sevoflurane-sufentanil balanced

PLACEBO COMPARATOR

balanced sevoflurane (end-tidal 1.2-2.8 vol%) and sufentanil (0.015 mcg/kg/min) regimen

Drug: sevoflurane-sufentanil balanced

Interventions

remifentanil-based DRUG

remifentanil-based

sevoflurane-sufentanil balanced DRUG

sevoflurane-sufentanil balanced

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients undergoing elective coronary artery bypass surgery

You may not qualify if:

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

Sponsors & Collaborators

• Konkuk University Medical Center: lead

Study Sites (1)

Konkuk University Medical Center

Seoul, 05030, South Korea

Location

Study Officials

• Tae-Yop Kim, MD, PhD

  Konkuk University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology

Study Record Dates

• First Submitted: March 15, 2016
• First Posted: March 18, 2016
• Study Start: May 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: December 6, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)