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

NCT ID: NCT03817359

Last Updated: 2019-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-03

Study Completion Date

2018-12-27

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Anesthetics Remifentanil Propofol

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Mix infusion using single TCI pump

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

Group Type EXPERIMENTAL

Remifentanil-propofol mixture

Intervention Type 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.

Separate infusion using two TCI pumps

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tri-Service General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Meng-Fu Lai

Resident physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zhi-Fu Wu, M.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesiology, Tri-Service General Hospital

Locations

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Tri-Service General hospital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

References

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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.

Reference Type RESULT
PMID: 30286006 (View on PubMed)

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.

Reference Type RESULT
PMID: 15500495 (View on PubMed)

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.

Reference Type RESULT
PMID: 10825339 (View on PubMed)

Other Identifiers

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2-107-05-079

Identifier Type: -

Identifier Source: org_study_id

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