Total Intravenous AnesthesiaNCT04394897
Total Intravenous Anesthesia With Remifentanil-propofol Admixture
An observational study of Total Intravenous Anesthesia and Propofol, run by Bezmialem Vakif University.
Trial summary
Background: Application of total intravenous anesthesia (TIVA) may be considered as unpractical when compared with inhalational anesthesia. Although it is mostly not recommended, mixing intravenous agents seems to be popular in clinical practice. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Total Intravenous Anesthesia, Propofol, Remifentanil
- What is being tested?
- Remifentanil-Propofol admixture
- Type of treatment
- Injection or infusion
- How many people
- 96 participants
- Where
- No sites listed yet
- Study dates
- 12 Mar 2013to 12 Apr 2014
- Phase
- Observational
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ASA I-II adult patients scheduled for elective thyroidectomy were randomly allocated into 3 groups (n= 32 for each)
Who may be able to join
- American Society of Anesthesiologists (ASA) physical status I patients American Society of Anesthesiologists (ASA) physical status II patients
Who cannot join
- American Society of Anesthesiologists (ASA) physical status III patients or above patients A body mass index >35 kg/m2 Pregnant patients Breast-feeding Menstruating women Patients who were not euthyroid Uncontrolled hypertension Hepatic, renal or cardiac insufficiency Alcohol, opioid or drug abuse Allergy or contraindication to any of the study drugs
About this study
Official title: Total Intravenous Anesthesia With Remifentanil-propofol Admixture Using Single-infusion Technique
Background: Application of total intravenous anesthesia (TIVA) may be considered as unpractical when compared with inhalational anesthesia. Although it is mostly not recommended, mixing intravenous agents seems to be popular in clinical practice. The aim of the study was to investigate the possible clinical drawbacks of using remifentanil-propofol admixture (MIXTIVA) for TIVA.
Read the detailed description
ASA I-II adult patients scheduled for elective thyroidectomy were randomly allocated into 3 groups (n= 32 for each) to have TIVA either with remifentanil and propofol infusions separately (control group, Group I) or with MIXTIVA infusion that had remifentanil/propofol proportion 2/1000 or 3/1000 (remifentanil concentration 20 µg/ml or 30 µg/ml in propofol 1%, Group II or Group III respectively).
This technique may be considered as a practical implementation for busy ambulatory surgery centers performing general anesthesia, but delayed recovery may be predicted with longer duration of surgery and anesthesia.
- Being tested
- Remifentanil-Propofol admixture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remifentanil-Propofol admixtureCombination product
| Study group | Role | What they receive |
|---|---|---|
| TIVA | TIVA either with remifentanil and propofol infusions separately | |
| MIXTIVA 2/1000 | MIXTIVA infusion that had remifentanil/propofol proportion 2/1000 Receives: Combination Product: Remifentanil-Propofol admixture | |
| MIXTIVA 3/1000 | MIXTIVA infusion that had remifentanil/propofol proportion 3/1000 Receives: Combination Product: Remifentanil-Propofol admixture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Rate Changes
Bradycardia: heart rate <45 beat per / min
Measured: During the application of TIVA
Blood Pressure Changes
Hypotension (MAP <60 mmHg), Hypertension( systolic arterial pressure >150 mmHg)
Measured: During the application of TIVA
Bispectral Index (BIS) Changes
BIS levels >60
Measured: During the application of TIVA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2020
- Study start12 Mar 2013
- Primary completion12 Apr 2014
- Study completion12 Apr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Total Intravenous AnesthesiaStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04394897
- Sponsor's protocol ID
- Bezmialem VU
- Status last verified
- May 2020
- First submitted
- 9 Apr 2020
- Last updated
- 20 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Anderson BJ, Bagshaw O. Practicalities of Total Intravenous Anesthesia and Target-controlled Infusion in Children. Anesthesiology. 2019 Jul;131(1):164-185. doi: 10.1097/ALN.0000000000002657.
PubMed 30920966Errando CL, Sigl JC, Robles M, Calabuig E, Garcia J, Arocas F, Higueras R, Del Rosario E, Lopez D, Peiro CM, Soriano JL, Chaves S, Gil F, Garcia-Aguado R. Awareness with recall during general anaesthesia: a prospective observational evaluation of 4001 patients. Br J Anaesth. 2008 Aug;101(2):178-85. doi: 10.1093/bja/aen144. Epub 2008 May 30.
PubMed 18515816Roberts FL, Dixon J, Lewis GT, Tackley RM, Prys-Roberts C. Induction and maintenance of propofol anaesthesia. A manual infusion scheme. Anaesthesia. 1988 Mar;43 Suppl:14-7. doi: 10.1111/j.1365-2044.1988.tb09061.x.
PubMed 3259089Lamperti M. Adult procedural sedation: an update. Curr Opin Anaesthesiol. 2015 Dec;28(6):662-7. doi: 10.1097/ACO.0000000000000244.
PubMed 26356290Weatherall A, Venclovas R. Experience with a propofol-ketamine mixture for sedation during pediatric orthopedic surgery. Paediatr Anaesth. 2010 Nov;20(11):1009-16. doi: 10.1111/j.1460-9592.2010.03420.x.
PubMed 20964766Bakan M, Umutoglu T, Topuz U, Guler EY, Uysal H, Ozturk E. Prospective evaluation of remifentanil-propofol mixture for total intravenous anesthesia: A randomized controlled study. Exp Ther Med. 2021 Nov;22(5):1198. doi: 10.3892/etm.2021.10632. Epub 2021 Aug 23.
PubMed 34584543
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Total Intravenous Anesthesia With Remifentanil-propofol Admixture Using Single-infusion Technique
- ClinicalTrials.gov ID
- NCT04394897
- Acronym / sponsor ID
- Bezmialem VU
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 12 Mar 2013 (actual)
- Primary completion
- 12 Apr 2014 (actual)
- Study completion
- 12 Apr 2014 (actual)
- First posted
- 20 May 2020 (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.
Background: Application of total intravenous anesthesia (TIVA) may be considered as unpractical when compared with inhalational anesthesia. Although it is mostly not recommended, mixing intravenous agents seems to be popular in clinical practice. The aim of the study was to investigate the possible clinical drawbacks of using remifentanil-propofol admixture (MIXTIVA) for TIVA.
Detailed description
ASA I-II adult patients scheduled for elective thyroidectomy were randomly allocated into 3 groups (n= 32 for each) to have TIVA either with remifentanil and propofol infusions separately (control group, Group I) or with MIXTIVA infusion that had remifentanil/propofol proportion 2/1000 or 3/1000 (remifentanil concentration 20 µg/ml or 30 µg/ml in propofol 1%, Group II or Group III respectively).
This technique may be considered as a practical implementation for busy ambulatory surgery centers performing general anesthesia, but delayed recovery may be predicted with longer duration of surgery and anesthesia.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TIVA | – | –TIVA either with remifentanil and propofol infusions separately |
| MIXTIVA 2/1000 | – | Combination Product: Remifentanil-Propofol admixtureMIXTIVA infusion that had remifentanil/propofol proportion 2/1000 |
| MIXTIVA 3/1000 | – | Combination Product: Remifentanil-Propofol admixtureMIXTIVA infusion that had remifentanil/propofol proportion 3/1000 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ASA I-II adult patients scheduled for elective thyroidectomy were randomly allocated into 3 groups (n= 32 for each)
Key inclusion criteria (1 listed)
- American Society of Anesthesiologists (ASA) physical status I patients American Society of Anesthesiologists (ASA) physical status II patients
Key exclusion criteria (1 listed)
- American Society of Anesthesiologists (ASA) physical status III patients or above patients A body mass index >35 kg/m2 Pregnant patients Breast-feeding Menstruating women Patients who were not euthyroid Uncontrolled hypertension Hepatic, renal or cardiac insufficiency Alcohol, opioid or drug abuse Allergy or contraindication to any of the study drugs
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 admixture | Combination product | MIXTIVA 2/1000, MIXTIVA 3/1000 |
Primary outcome
Heart Rate Changes
Time frame: During the application of TIVA
Bradycardia: heart rate <45 beat per / min
Blood Pressure Changes
Time frame: During the application of TIVA
Hypotension (MAP <60 mmHg), Hypertension( systolic arterial pressure >150 mmHg)
Bispectral Index (BIS) Changes
Time frame: During the application of TIVA
BIS levels >60
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 20 May 2020.
- Background: PubMed 30920966Anderson BJ, Bagshaw O. Practicalities of Total Intravenous Anesthesia and Target-controlled Infusion in Children. Anesthesiology. 2019 Jul;131(1):164-185. doi: 10.1097/ALN.0000000000002657.
- Background: PubMed 18515816Errando CL, Sigl JC, Robles M, Calabuig E, Garcia J, Arocas F, Higueras R, Del Rosario E, Lopez D, Peiro CM, Soriano JL, Chaves S, Gil F, Garcia-Aguado R. Awareness with recall during general anaesthesia: a prospective observational evaluation of 4001 patients. Br J Anaesth. 2008 Aug;101(2):178-85. doi: 10.1093/bja/aen144. Epub 2008 May 30.
- Background: PubMed 3259089Roberts FL, Dixon J, Lewis GT, Tackley RM, Prys-Roberts C. Induction and maintenance of propofol anaesthesia. A manual infusion scheme. Anaesthesia. 1988 Mar;43 Suppl:14-7. doi: 10.1111/j.1365-2044.1988.tb09061.x.
- Background: PubMed 26356290Lamperti M. Adult procedural sedation: an update. Curr Opin Anaesthesiol. 2015 Dec;28(6):662-7. doi: 10.1097/ACO.0000000000000244.
- Background: PubMed 20964766Weatherall A, Venclovas R. Experience with a propofol-ketamine mixture for sedation during pediatric orthopedic surgery. Paediatr Anaesth. 2010 Nov;20(11):1009-16. doi: 10.1111/j.1460-9592.2010.03420.x.
- Derived from this study: PubMed 34584543Bakan M, Umutoglu T, Topuz U, Guler EY, Uysal H, Ozturk E. Prospective evaluation of remifentanil-propofol mixture for total intravenous anesthesia: A randomized controlled study. Exp Ther Med. 2021 Nov;22(5):1198. doi: 10.3892/etm.2021.10632. Epub 2021 Aug 23.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Total Intravenous Anesthesia and Propofol, run by Bezmialem Vakif University.
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 1 inclusion and 1 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 20 May 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Heart Rate Changes (time frame: During the application of TIVA). The study lists 3 primary outcomes in all. 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 NCT04394897, which also lists 6 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 20 May 2020.