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Clinical Trials/NCT03817359
NCT03817359
Completed
Not Applicable

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

Tri-Service General Hospital1 site in 1 country84 target enrollmentAugust 3, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anesthetics
Sponsor
Tri-Service General Hospital
Enrollment
84
Locations
1
Primary Endpoint
Frequency of TCI device adjustments
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
August 3, 2018
End Date
December 27, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Meng-Fu Lai

Resident physician

Tri-Service General Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

Frequency of TCI device adjustments

Time Frame: during procedure

Total times of TCI pump adjustment

Secondary Outcomes

  • Mean blood pressure(at 5 minute intervals perioperatively throughout the procedure in an average of 60 minutes)
  • Patient satisfaction(the 1 day after operation)
  • postoperative analgesia rescue(An average of 30 minutes after arriving at PACU)
  • Total dose of remifentanil(At the end of surgery)
  • Heart rate(at 5 minute intervals perioperatively throughout the procedure in an average of 60 minutes)
  • Total dose of propofol(At the end of surgery)

Study Sites (1)

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