Total Intravenous Anesthesia With Remifentanil-propofol Admixture

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Total Intravenous Anesthesia, Propofol, Remifentanil, Bispectral Index Monitoring

Intervention / Treatment
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* Combination Product: Remifentanil-Propofol admixture


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| TIVA<br>TIVA either with remifentanil and propofol infusions separately | |
| MIXTIVA 2/1000<br>MIXTIVA infusion that had remifentanil/propofol proportion 2/1000 | Combination Product: Remifentanil-Propofol admixture<br> <br> |
| MIXTIVA 3/1000<br>MIXTIVA infusion that had remifentanil/propofol proportion 3/1000 | Combination Product: Remifentanil-Propofol admixture<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart Rate Changes | Bradycardia: heart rate <45 beat per / min | During the application of TIVA | 
| Blood Pressure Changes | Hypotension (MAP <60 mmHg), Hypertension( systolic arterial pressure >150 mmHg) | During the application of TIVA | 
| Bispectral Index (BIS) Changes | BIS levels >60 | During the application of TIVA |