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

NCT03817359 | Completed

• 1 other identifier: 2-107-05-079
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthetics; Remifentanil; Propofol

Keywords

propofol; remifentanil; total intravenous anesthesia; breast surgery

Outcome Measures

Primary Outcomes (1)

• Frequency of TCI device adjustments

  Total times of TCI pump adjustment

  during procedure

Secondary Outcomes (6)

• Mean blood pressure

  at 5 minute intervals perioperatively throughout the procedure in an average of 60 minutes

• Heart rate

  at 5 minute intervals perioperatively throughout the procedure in an average of 60 minutes

• Patient satisfaction

  the 1 day after operation

• postoperative analgesia rescue

  An average of 30 minutes after arriving at PACU

• Total dose of remifentanil

  At the end of surgery

Study Arms (2)

Mix infusion using single TCI pump

EXPERIMENTAL

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

Combination Product: Remifentanil-propofol mixture

Separate infusion using two TCI pumps

NO INTERVENTION

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

Interventions

Remifentanil-propofol mixture COMBINATION_PRODUCT

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.

Mix infusion using single TCI pump

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA II or III
• age more than 18 years
• scheduled for breast cancer surgery under general anesthesia.

You may not qualify if:

• previously allergic to propofol or remifentanil
• combining other surgical procedure leading to extended operative time

Sponsors & Collaborators

• Tri-Service General Hospital: lead

Study Sites (1)

Tri-Service General hospital

Taipei, 114, Taiwan

Location

Related Publications (3)

• 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.

  PMID: 30286006 RESULT

• 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.

  PMID: 15500495 RESULT

• 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.

  PMID: 10825339 RESULT

Study Officials

• Zhi-Fu Wu, M.D.

  Department of Anesthesiology, Tri-Service General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident physician

Model Details: 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.

Study Record Dates

• First Submitted: January 19, 2019
• First Posted: January 25, 2019
• Study Start: August 3, 2018
• Primary Completion: December 27, 2018
• Study Completion: December 27, 2018
• Last Updated: January 30, 2019

Record last verified: 2019-01

Locations

TW (1)