Propofol Clinical Trial
Official title:
Use of a Remifentanil-propofol Mixture in Patients With Breast Cancer Undergoing Breast Cancer Surgery: a Prospective Pilot Study
Verified date | January 2019 |
Source | Tri-Service General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 84 |
Est. completion date | December 27, 2018 |
Est. primary completion date | December 27, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Taiwan | Tri-Service General hospital | Taipei |
Lead Sponsor | Collaborator |
---|---|
Tri-Service General Hospital |
Taiwan,
Bedocs P, Evers DL, Buckenmaier CC 3rd. Predosing Chemical Stability of Admixtures of Propofol, Ketamine, Fentanyl, and Remifentanil. Anesth Analg. 2018 Oct 3. doi: 10.1213/ANE.0000000000003772. [Epub ahead of print] — View 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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Frequency of TCI device adjustments | Total times of TCI pump adjustment | during procedure | |
Secondary | Mean blood pressure | measured by non-invasive blood pressure cuff | at 5 minute intervals perioperatively throughout the procedure in an average of 60 minutes | |
Secondary | Heart rate | recorded by ECG and pulse oximetry | at 5 minute intervals perioperatively throughout the procedure in an average of 60 minutes | |
Secondary | Patient satisfaction | Rating of satisfaction by questionnaire | the 1 day after operation | |
Secondary | postoperative analgesia rescue | Analgesics use during PACU stay | An average of 30 minutes after arriving at PACU | |
Secondary | Total dose of remifentanil | total consumption of remifentanil during procedure | At the end of surgery | |
Secondary | Total dose of propofol | total consumption of propofol during procedure | At the end of surgery |
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