Clinical trial NCT04394897: Total Intravenous Anesthesia With Remifentanil-propofol Admixture
Official title: Total Intravenous Anesthesia With Remifentanil-propofol Admixture Using Single-infusion Technique
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Total Intravenous Anesthesia
Propofol
Remifentanil
Bispectral Index Monitoring
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2020-05-20
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: ASA I-II adult patients scheduled for elective thyroidectomy were randomly allocated into 3 groups (n= 32 for each)

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.

Eligibility criteria: 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

Primary outcomes:
measure: Heart Rate Changes
timeFrame: During the application of TIVA
measure: Blood Pressure Changes
timeFrame: During the application of TIVA
measure: Bispectral Index (BIS) Changes
timeFrame: During the application of TIVA
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
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citation: Bakan M, Umutoglu T, Topuz U, Guler EY, Uysal H, Ozturk E. Prospective evaluation of remifentanil-propofol mixture for total intravenous anesthesia: A randomized controlled study. Exp Ther Med. 2021 Nov;22(5):1198. doi: 10.3892/etm.2021.10632. Epub 2021 Aug 23.