Total Intravenous Anesthesia With Remifentanil-propofol Admixture

Background: Application of total intravenous anesthesia (TIVA) may be considered as unpractical when compared with inhalational anesthesia. Although it is mostly not recommended, mixing intravenous agents seems to be popular in clinical practice. The aim of the study was to investigate the possible clinical drawbacks of using remifentanil-propofol admixture (MIXTIVA) for TIVA.

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Key information

Conditions

Total Intravenous Anesthesia Bispectral Index Monitoring Propofol Remifentanil

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

About this study

ASA I-II adult patients scheduled for elective thyroidectomy were randomly allocated into 3 groups (n= 32 for each) to have TIVA either with remifentanil and propofol infusions separately (control group, Group I) or with MIXTIVA infusion that had remifentanil/propofol proportion 2/1000 or 3/1000 (remifentanil concentration 20 µg/ml or 30 µg/ml in propofol 1%, Group II or Group III respectively).

This technique may be considered as a practical implementation for busy ambulatory surgery centers performing general anesthesia, but delayed recovery may be predicted with longer duration of surgery and anesthesia.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

American Society of Anesthesiologists (ASA) physical status I patients American Society of Anesthesiologists (ASA) physical status II patients

Exclusion criteria

American Society of Anesthesiologists (ASA) physical status III patients or above patients A body mass index >35 kg/m2 Pregnant patients Breast-feeding Menstruating women Patients who were not euthyroid Uncontrolled hypertension Hepatic, renal or cardiac insufficiency Alcohol, opioid or drug abuse Allergy or contraindication to any of the study drugs

Treatment and study plan

Remifentanil-Propofol admixture

Combination Product

Primary outcomes

Heart Rate Changes

Time frame: During the application of TIVA

Bradycardia: heart rate <45 beat per / min
Blood Pressure Changes

Time frame: During the application of TIVA

Hypotension (MAP <60 mmHg), Hypertension( systolic arterial pressure >150 mmHg)
Bispectral Index (BIS) Changes

Time frame: During the application of TIVA

BIS levels >60

Sponsors and collaborators

Lead sponsor

Bezmialem Vakif University

Other

Registry information

Official study title

Total Intravenous Anesthesia With Remifentanil-propofol Admixture Using Single-infusion Technique

Important dates

Study start: 2013
Primary completion: 2014
Study completion: 2014
First posted: May 20, 2020
Registry last updated: May 20, 2020

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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