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

Tri-Service General Hospital

Status: Completed

Conditions: Anesthetics; Propofol; Remifentanil

Treatments: Combination Product: Remifentanil-propofol mixture

Study type: Interventional

Funder types: Other

Identifiers

NCT03817359

2-107-05-079

Details and patient eligibility

About

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.

Full 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.

Enrollment: 84 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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84 participants in 2 patient groups

Mix infusion using single TCI pump

Experimental group

Description:

participants receive total intravenous anesthesia with remifentanil-propofol mixture by single TCI pump infusion

Treatment:

Combination Product: Remifentanil-propofol mixture

Separate infusion using two TCI pumps

No Intervention group

Description:

participants receive total intravenous anesthesia with remifentanil and propofol separately by two TCI pumps infusion