Use of a Remifentanil-propofol Mixture in Patients Undergoing Breast Cancer Surgery
- Conditions
- AnestheticsPropofolRemifentanil
- Interventions
- Combination Product: Remifentanil-propofol mixture
- Registration Number
- NCT03817359
- Lead Sponsor
- Tri-Service General Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 84
- ASA II or III
- age more than 18 years
- scheduled for breast cancer surgery under general anesthesia.
- previously allergic to propofol or remifentanil
- combining other surgical procedure leading to extended operative time
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Mix infusion using single TCI pump Remifentanil-propofol mixture participants receive total intravenous anesthesia with remifentanil-propofol mixture by single TCI pump infusion
- Primary Outcome Measures
Name Time Method Frequency of TCI device adjustments during procedure Total times of TCI pump adjustment
- Secondary Outcome Measures
Name Time Method Mean blood pressure at 5 minute intervals perioperatively throughout the procedure in an average of 60 minutes measured by non-invasive blood pressure cuff
Patient satisfaction the 1 day after operation Rating of satisfaction by questionnaire
postoperative analgesia rescue An average of 30 minutes after arriving at PACU Analgesics use during PACU stay
Total dose of remifentanil At the end of surgery total consumption of remifentanil during procedure
Heart rate at 5 minute intervals perioperatively throughout the procedure in an average of 60 minutes recorded by ECG and pulse oximetry
Total dose of propofol At the end of surgery total consumption of propofol during procedure
Trial Locations
- Locations (1)
Tri-Service General hospital
🇨🇳Taipei, Taiwan