Use of a Remifentanil-propofol Mixture in Patients Undergoing Breast Cancer Surgery

January 28, 2019 updated by: Meng-Fu Lai, Tri-Service General Hospital

Use of a Remifentanil-propofol Mixture in Patients With Breast Cancer Undergoing Breast Cancer Surgery: a Prospective Pilot Study

Co-administration of propofol and remifentanil is considered to be an ideal total intravenous anesthesia technique, which is widely used in induction and maintenance of general anesthesia. Remifentanil and propofol can be mixed in polypropylene syringes for one hour with a remaining concentration of 91% in small concentrations of remifentanil. However, delivery of remifentanil-propofol mixture by target-controlled infusion(TCI) for general anesthesia in surgical procedure has not been described. Breast cancer surgery ( including modified radical mastectomy and breast-conserving surgery) is a less time-consuming procedure for patients with breast cancer with one-hour duration in our hospital. This pilot study was to examine the merit of remifentanil-propofol mixture as a GA regimen for breast cancer surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Previous studies has described the feasibility and safety of remifentanil-propofol mixture use in sedation of pediatric patients undergoing magnetic resonance imaging or flexible fiberoptic bronchoscopy.

Study Type

Interventional

Enrollment (Actual)

84

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 114
        • Tri-Service General Hospital

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ASA II or III
  • age more than 18 years
  • scheduled for breast cancer surgery under general anesthesia.

Exclusion Criteria:

  • previously allergic to propofol or remifentanil
  • combining other surgical procedure leading to extended operative time

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mix infusion using single TCI pump
participants receive total intravenous anesthesia with remifentanil-propofol mixture by single TCI pump infusion
Combination product: Remifentanil-propofol mixture
Participants receive total intravenous anesthesia with remifentanil-propofol mixture by single TCI pump in intervention group. All TCI target concentration adjustments or extra bolus of propofol or remifentanil during operation were based on BIS and ANI monitor.
No Intervention: Separate infusion using two TCI pumps
participants receive total intravenous anesthesia with remifentanil and propofol separately by two TCI pumps infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of TCI device adjustments
Time Frame: during procedure
Total times of TCI pump adjustment
during procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean blood pressure
Time Frame: at 5 minute intervals perioperatively throughout the procedure in an average of 60 minutes
measured by non-invasive blood pressure cuff
at 5 minute intervals perioperatively throughout the procedure in an average of 60 minutes
Heart rate
Time Frame: at 5 minute intervals perioperatively throughout the procedure in an average of 60 minutes
recorded by ECG and pulse oximetry
at 5 minute intervals perioperatively throughout the procedure in an average of 60 minutes
Patient satisfaction
Time Frame: the 1 day after operation
Rating of satisfaction by questionnaire
the 1 day after operation
postoperative analgesia rescue
Time Frame: An average of 30 minutes after arriving at PACU
Analgesics use during PACU stay
An average of 30 minutes after arriving at PACU
Total dose of remifentanil
Time Frame: At the end of surgery
total consumption of remifentanil during procedure
At the end of surgery
Total dose of propofol
Time Frame: At the end of surgery
total consumption of propofol during procedure
At the end of surgery

Collaborators and Investigators

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

Sponsor

Tri-Service General Hospital

Investigators

  • Principal Investigator: Zhi-Fu Wu, M.D., Department of Anesthesiology, Tri-Service General Hospital

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)

August 3, 2018

Primary Completion (Actual)

December 27, 2018

Study Completion (Actual)

December 27, 2018

Study Registration Dates

First Submitted

January 19, 2019

First Submitted That Met QC Criteria

January 24, 2019

First Posted (Actual)

January 25, 2019

Study Record Updates

Last Update Posted (Actual)

January 30, 2019

Last Update Submitted That Met QC Criteria

January 28, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2-107-05-079

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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.

Clinical Trials on Propofol

Clinical Trials on Remifentanil-propofol mixture

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Papua New Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe