AnestheticsNCT03817359
Use of a Remifentanil-propofol Mixture in Patients Undergoing Breast Cancer Surgery
A study testing Remifentanil-propofol mixture in people with Anesthetics and Remifentanil, run by Tri-Service General Hospital (TSGH) at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthetics, Remifentanil, Propofol
- What is being tested?
- Remifentanil-propofol mixture
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteTaiwan
- Study dates
- 3 Aug 2018to 27 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA II or III
- age more than 18 years
- scheduled for breast cancer surgery under general anesthesia.
Who cannot join
- previously allergic to propofol or remifentanil
- combining other surgical procedure leading to extended operative time
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of a Remifentanil-propofol Mixture in Patients With Breast Cancer Undergoing Breast Cancer Surgery: a Prospective Pilot Study
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.
Read the detailed 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.
- Conditions
- Anesthetics, Remifentanil, Propofol
- Being tested
- Remifentanil-propofol mixture
- Keywords
- propofol, remifentanil, total intravenous anesthesia, breast surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remifentanil-propofol mixtureCombination 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.
| Study group | Role | What they receive |
|---|---|---|
| Mix infusion using single TCI pump | Experimental | participants receive total intravenous anesthesia with remifentanil-propofol mixture by single TCI pump infusion Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of TCI device adjustments
Total times of TCI pump adjustment
Measured: during procedure
Secondary outcomes (6)
Mean blood pressure
measured by non-invasive blood pressure cuff
Measured: at 5 minute intervals perioperatively throughout the procedure in an average of 60 minutes
Heart rate
recorded by ECG and pulse oximetry
Measured: at 5 minute intervals perioperatively throughout the procedure in an average of 60 minutes
Patient satisfaction
Rating of satisfaction by questionnaire
Measured: the 1 day after operation
postoperative analgesia rescue
Analgesics use during PACU stay
Measured: An average of 30 minutes after arriving at PACU
Total dose of remifentanil
total consumption of remifentanil during procedure
Measured: At the end of surgery
Total dose of propofol
total consumption of propofol during procedure
Measured: At the end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2019
- Study start3 Aug 2018
- Primary completion27 Dec 2018
- Study completion27 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AnestheticsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tri-Service General Hospital (TSGH)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meng-Fu Lai, Tri-Service General Hospital (TSGH)
- Investigators
- Zhi-Fu Wu, M.D., Principal investigator, Department of Anesthesiology, Tri-Service General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03817359
- Sponsor's protocol ID
- 2-107-05-079
- Status last verified
- Jan 2019
- First submitted
- 19 Jan 2019
- Last updated
- 30 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 30286006Berkenbosch 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.
PubMed 15500495Stewart 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.
PubMed 10825339
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of a Remifentanil-propofol Mixture in Patients With Breast Cancer Undergoing Breast Cancer Surgery: a Prospective Pilot Study
- ClinicalTrials.gov ID
- NCT03817359
- Acronym / sponsor ID
- 2-107-05-079
- Conditions
- Anesthetics, Remifentanil, Propofol
- Keywords
- propofol, remifentanil, total intravenous anesthesia, breast surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Tri-Service General Hospital (TSGH)University, hospital or other
- Study start
- 3 Aug 2018 (actual)
- Primary completion
- 27 Dec 2018 (actual)
- Study completion
- 27 Dec 2018 (actual)
- First posted
- 25 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Mix infusion using single TCI pump | Experimental | Combination Product: Remifentanil-propofol mixtureparticipants receive total intravenous anesthesia with remifentanil-propofol mixture by single TCI pump infusion |
| Separate infusion using two TCI pumps | No intervention | –participants receive total intravenous anesthesia with remifentanil and propofol separately by two TCI pumps infusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA II or III
- age more than 18 years
- scheduled for breast cancer surgery under general anesthesia.
Key exclusion criteria (2 listed)
- previously allergic to propofol or remifentanil
- combining other surgical procedure leading to extended operative time
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remifentanil-propofol mixtureParticipants 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. | Combination product | Mix infusion using single TCI pump |
Primary outcome
Frequency of TCI device adjustments
Time frame: during procedure
Total times of TCI pump adjustment
6 secondary outcomes
Mean blood pressure
Time frame: at 5 minute intervals perioperatively throughout the procedure in an average of 60 minutes
Heart rate
Time frame: at 5 minute intervals perioperatively throughout the procedure in an average of 60 minutes
Patient satisfaction
Time frame: the 1 day after operation
postoperative analgesia rescue
Time frame: An average of 30 minutes after arriving at PACU
Total dose of remifentanil
Time frame: At the end of surgery
Total dose of propofol
Time frame: At the end of surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2019.
- Results publication: PubMed 30286006Bedocs 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.
- Results publication: PubMed 15500495Berkenbosch 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.
- Results publication: PubMed 10825339Stewart 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhi-Fu Wu, M.D. principal investigator
Department of Anesthesiology, Tri-Service General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remifentanil-propofol mixture in people with Anesthetics and Remifentanil, run by Tri-Service General Hospital (TSGH) at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of TCI device adjustments (time frame: during procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03817359, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2019.