Clinical trial NCT03817359: Use of a Remifentanil-propofol Mixture in Patients Undergoing Breast Cancer Surgery
Official title: Use of a Remifentanil-propofol Mixture in Patients With Breast Cancer Undergoing Breast Cancer Surgery: a Prospective Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthetics
Remifentanil
Propofol
Keywords: propofol
remifentanil
total intravenous anesthesia
breast surgery
Lead sponsor: Tri-Service General Hospital
Sponsor class: OTHER
First posted: 2019-01-25
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Frequency of TCI device adjustments
timeFrame: during procedure
Secondary outcomes:
measure: Mean blood pressure
timeFrame: at 5 minute intervals perioperatively throughout the procedure in an average of 60 minutes
measure: Heart rate
timeFrame: at 5 minute intervals perioperatively throughout the procedure in an average of 60 minutes
measure: Patient satisfaction
timeFrame: the 1 day after operation
measure: postoperative analgesia rescue
timeFrame: An average of 30 minutes after arriving at PACU
measure: Total dose of remifentanil
timeFrame: At the end of surgery
measure: Total dose of propofol
timeFrame: At the end of surgery
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Tri-Service General hospital
Study officials:
affiliation: Department of Anesthesiology, Tri-Service General Hospital
name: Zhi-Fu Wu, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bedocs P, Evers DL, Buckenmaier CC 3rd. Predosing Chemical Stability of Admixtures of Propofol, Ketamine, Fentanyl, and Remifentanil. Anesth Analg. 2019 Jul;129(1):e13-e15. doi: 10.1213/ANE.0000000000003772.
citation: Berkenbosch JW, Graff GR, Stark JM, Ner Z, Tobias JD. Use of a remifentanil-propofol mixture for pediatric flexible fiberoptic bronchoscopy sedation. Paediatr Anaesth. 2004 Nov;14(11):941-6. doi: 10.1111/j.1460-9592.2004.01355.x.
citation: Stewart JT, Warren FW, Maddox FC, Viswanathan K, Fox JL. The stability of remifentanil hydrochloride and propofol mixtures in polypropylene syringes and polyvinylchloride bags at 22 degrees-24 degrees C. Anesth Analg. 2000 Jun;90(6):1450-1. doi: 10.1097/00000539-200006000-00037.