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

Study 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.

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

Conditions
-----------------
Anesthetics, Remifentanil, Propofol

Intervention / Treatment
-----------------
* Combination Product: Remifentanil-propofol mixture


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mix infusion using single TCI pump<br>participants receive total intravenous anesthesia with remifentanil-propofol mixture by single TCI pump infusion | Combination Product: Remifentanil-propofol mixture<br>* 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.<br>|
| No Intervention: Separate infusion using two TCI pumps<br>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 | Total times of TCI pump adjustment | during procedure | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
propofol, remifentanil, total intravenous anesthesia, breast surgery