MedDataX Logo

Recovery Profiles of Remifentanil-based Regimen for Cardiac Surgery

NCT ID: NCT02712528

Last Updated: 2017-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2016-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cardiac Surgery

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

bispectral index extubation recovery remifentanil

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

remifentanil-based

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

Group Type ACTIVE_COMPARATOR

remifentanil-based

Intervention Type DRUG

sevoflurane-sufentanil balanced

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

Group Type PLACEBO_COMPARATOR

sevoflurane-sufentanil balanced

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

remifentanil-based

Intervention Type DRUG

sevoflurane-sufentanil balanced

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

19 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Konkuk University Medical Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Tae-Yop Kim, MD PhD

Professor of Anesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Tae-Yop Kim, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Konkuk University Medical Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Konkuk University Medical Center

Seoul, , South Korea

Site Status

Countries

Review the countries where the study has at least one active or historical site.

South Korea

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

KUH1160080

Identifier Type: -

Identifier Source: org_study_id