Total Intravenous Anesthesia With Remifentanil-propofol Admixture

May 14, 2020 updated by: Bezmialem Vakif University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

96

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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)

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bezmialem Vakif University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 12, 2013

Primary Completion (Actual)

April 12, 2014

Study Completion (Actual)

April 12, 2014

Study Registration Dates

First Submitted

April 9, 2020

First Submitted That Met QC Criteria

May 14, 2020

First Posted (Actual)

May 20, 2020

Study Record Updates

Last Update Posted (Actual)

May 20, 2020

Last Update Submitted That Met QC Criteria

May 14, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Bezmialem VU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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