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Total Intravenous Anesthesia With Remifentanil-propofol Admixture

B

Bezmialem Vakif University

Status

Completed

Conditions

Total Intravenous Anesthesia
Bispectral Index Monitoring
Propofol
Remifentanil

Treatments

Combination Product: Remifentanil-Propofol admixture

Study type

Observational

Funder types

Other

Identifiers

NCT04394897
Bezmialem VU

Details and patient eligibility

About

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.

Full description

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.

Enrollment

96 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

96 participants in 3 patient groups

TIVA
Description:
TIVA either with remifentanil and propofol infusions separately
MIXTIVA 2/1000
Description:
MIXTIVA infusion that had remifentanil/propofol proportion 2/1000
Treatment:
Combination Product: Remifentanil-Propofol admixture
MIXTIVA 3/1000
Description:
MIXTIVA infusion that had remifentanil/propofol proportion 3/1000
Treatment:
Combination Product: Remifentanil-Propofol admixture

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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