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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03817359
Enrollment
84
Registered
2019-01-25
Start date
2018-08-03
Completion date
2018-12-27
Last updated
2019-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthetics, Propofol, Remifentanil

Keywords

propofol, remifentanil, total intravenous anesthesia, breast surgery

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.

Interventions

COMBINATION_PRODUCTRemifentanil-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.

Sponsors

Tri-Service General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Intervention model description

84 patients scheduled for breast cancer surgery were randomly allocated to receive TIVA with propofol and remifentanil separately by two TCI pump (Separate group) or with remifentanil-propofol mixture by single TCI pump (Mix group), all TCI concentration adjustments during operation were based on BIS and ANI monitor.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Frequency of TCI device adjustmentsduring procedureTotal times of TCI pump adjustment

Secondary

MeasureTime frameDescription
Heart rateat 5 minute intervals perioperatively throughout the procedure in an average of 60 minutesrecorded by ECG and pulse oximetry
Patient satisfactionthe 1 day after operationRating of satisfaction by questionnaire
Mean blood pressureat 5 minute intervals perioperatively throughout the procedure in an average of 60 minutesmeasured by non-invasive blood pressure cuff
Total dose of remifentanilAt the end of surgerytotal consumption of remifentanil during procedure
Total dose of propofolAt the end of surgerytotal consumption of propofol during procedure
postoperative analgesia rescueAn average of 30 minutes after arriving at PACUAnalgesics use during PACU stay

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026