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Completed

NCT Number: NCT03817359

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

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.

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Key information

Conditions

Anesthetics Propofol Remifentanil

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tri-Service General hospital

Taipei, 114, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Frequency of TCI device adjustments

    Time frame: during procedure

    Total times of TCI pump adjustment

Secondary outcomes

  1. Mean blood pressure

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

    measured by non-invasive blood pressure cuff

  2. Heart rate

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

    recorded by ECG and pulse oximetry

  3. Patient satisfaction

    Time frame: the 1 day after operation

    Rating of satisfaction by questionnaire

  4. postoperative analgesia rescue

    Time frame: An average of 30 minutes after arriving at PACU

    Analgesics use during PACU stay

  5. Total dose of remifentanil

    Time frame: At the end of surgery

    total consumption of remifentanil during procedure

  6. Total dose of propofol

    Time frame: At the end of surgery

    total consumption of propofol during procedure

Sponsors and collaborators

Lead sponsor

Tri-Service General Hospital (TSGH)

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jan 25, 2019
Registry last updated
Jan 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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