Remifentanil Anesthesia and Postoperative BIS in Cardiac Surgery

NCT02400879 | Completed DMC

• 1 other identifier: KUH-1160080
• Study Type: interventional
• Target: 38
• Locations: 0 countries
• Sites: N/A

Brief Summary

Background: Although remifentanil based anesthesia has been preferred for fast-track cardiac anesthesia, its recovery profile in cognitive function has not been investigated. Authors determined postoperative Bispectral index (BIS) score as well as extubation time after remifentanil-based propofol-supplemented anesthesia and compared them with those after conventional balanced sevoflurane-sufentanil anesthesia. Methods: Patients undergoing cardiac surgery using moderate hypothermic cardiopulmonary bypass (CPB) will be randomly allocated to get remifentanil-based propofol-supplemented (Group R) or conventional sevoflurane-sufentanil regimen (Group C) in the study period. For anesthetic induction and maintenance, fixed target controlled infusion (TCI) of remifentanil (plasma concentration 20 ng/ml) and TCI-propofol for maintaining BIS score 40-60 (effect concentration 0.8-1.5 μg/ml) in Group R, and TCI-sufentanil (Cp 0.4- 0.8 ng/ml) and sevoflurane inhalation for maintaining 80-120 % of baseline BP and BIS \< 60 (\< 1.5 MAC) in Group C, respectively. Authors will analyze postoperative recovery of cognitive function by using BIS after the use of remifentanil-based propofol-supplemented anesthesia for cardiac surgery and to compare them to those after the use of conventional balanced sevoflurane-sufentanil anesthesia.

Conditions

Cardiovascular Disease

Keywords

bispectral index; cardiac surgery; recovery; remifentanil

Outcome Measures

Primary Outcomes (1)

• time to achieving BIS>80

  The duration from the end of surgery to the time of achieving BIS score \> 80 (BIS\>80 persisting \> 3 min)

  5 min

Secondary Outcomes (2)

• time to achieve SIMV ventilation mode

  5 min

• time to achieve extubation

  5 min

Study Arms (2)

Remifentanil

ACTIVE COMPARATOR

For anesthesia maintenance, TCI-remifentanil (fixed Cp of 20 ng/ml) and TCI-propofol (variable Ce \< 2.0 µg/ml) for maintaining BIS 40-60

Drug: Remifentanil

sevoflurane and sufentanil

PLACEBO COMPARATOR

TCI-sufentnail (Cp of 0.4-0.8 ng/ml) and sevoflurane (\< 1.5 MAC) for maintaining 80-120 % of preoperative value and BIS \< 60

Drug: sevoflurane and sufentanil

Interventions

Remifentanil DRUG

administering remifentanil infusion 0.7-0.8 mcg/kg/min for anesthesia maintenance

Also known as: ultiva, GSK

Remifentanil

sevoflurane and sufentanil DRUG

administering sevoflurane and sufentanil for anesthesia maintenance

Also known as: sevorane and sufental

sevoflurane and sufentanil

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing cardiac valve repair or replacement surgery under moderate hypothermic cardiopulmonary bypass (CPB).
• All patients should provide written informed consents

You may not qualify if:

• urgent or emergent surgery,
• left ventricle (LV) ejection fraction \< 50%,
• application of intraaortic balloon pump (IABP),
• myocardial infarction,
• neurologic deficit,
• hepatic or renal impairment,
• pacing,
• inotropic medication,
• neurologic deficit.
• CPB application \> 250 min,
• transfused of packed red blood cell (pRBC) \> 5 units,
• post-CPB use of double inotropic support \> 30 min ,
• post-CPB pacing,
• IABP
• IABP

Sponsors & Collaborators

• Konkuk University Medical Center: lead

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Remifentanil; halofantrine; Sevoflurane; Sufentanil

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Methyl Ethers; Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Fentanyl

Study Officials

• Tae-Yop Kim, MD, PhD

  Konkuk Univeristy Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor of Anesthesiology

Study Record Dates

• First Submitted: March 15, 2015
• First Posted: March 27, 2015
• Study Start: October 1, 2015
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2016
• Last Updated: August 19, 2020

Record last verified: 2020-08