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Total Intravenous Anesthesia With Remifentanil-propofol Admixture

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04394897
Enrollment
96
Registered
2020-05-20
Start date
2013-03-12
Completion date
2014-04-12
Last updated
2020-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bispectral Index Monitoring, Propofol, Remifentanil, Total Intravenous Anesthesia

Brief summary

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.

Detailed 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.

Interventions

COMBINATION_PRODUCTRemifentanil-Propofol admixture

Sponsors

Bezmialem Vakif University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Blood Pressure ChangesDuring the application of TIVAHypotension (MAP \<60 mmHg), Hypertension( systolic arterial pressure \>150 mmHg)
Bispectral Index (BIS) ChangesDuring the application of TIVABIS levels \>60
Heart Rate ChangesDuring the application of TIVABradycardia: heart rate \<45 beat per / min

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026