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

Propofol Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03817359
• Other study ID #: 2-107-05-079
• Status: Completed
• Phase: N/A
• Start date: August 3, 2018
• Est. completion date: December 27, 2018

Study information

• Verified date: January 2019
• Source: Tri-Service General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• 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

Related Conditions & MeSH terms

• Anesthetics
• Propofol
• Remifentanil

Intervention

Combination Product:
• Remifentanil-propofol mixture
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.

Locations

Country	Name	City	State
Taiwan	Tri-Service General hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Tri-Service General Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (3)

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

Outcome

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