Total Intravenous Anesthesia With Remifentanil-propofol Admixture

Completed

• Conditions: Total Intravenous Anesthesia; Bispectral Index Monitoring; Remifentanil; Propofol
• Interventions: Combination Product: Remifentanil-Propofol admixture

• Registration Number: NCT04394897
• Lead Sponsor: Bezmialem Vakif University

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.

Study Timeline

• Study Start: 2013-03-12
• Primary Completion: 2014-04-12
• Study Completion: 2014-04-12
• Study First Submitted: 2020-04-09
• Status Verified: 2020-05
• Study First Submitted QC: 2020-05-14
• Last Update Submitted: 2020-05-14
• Study First Posted: 2020-05-20
• Last Update Posted: 2020-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
MIXTIVA 3/1000	Remifentanil-Propofol admixture	MIXTIVA infusion that had remifentanil/propofol proportion 3/1000
MIXTIVA 2/1000	Remifentanil-Propofol admixture	MIXTIVA infusion that had remifentanil/propofol proportion 2/1000

Primary Outcome Measures

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