Bispectral IndexNCT00760253
Compare the Side Effects and Difference Awake Level of Three TCI Propofol Formula in TVOR Patients
An observational study of Bispectral Index and Transcutaneous Carbon Dioxide, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
This study is to find the fewer side effects formula of anesthesia for TVOR patients, to compare the BIS level during emergence and to find the correlation between BIS and transcutaneous carbon dioxide concentration. Read more about this study
- Who is it for?
- Ages 25 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Bispectral Index, Transcutaneous Carbon Dioxide, PONV
- Type of treatment
- Injection or infusion
- How many people
- 118 participants
- Where
- 1 siteTaiwan
- Study dates
- Sep 2008to Dec 2008
- 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 25 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: ASA physical status I or II women age between 25 and 45 y/o participating to receive TVOR procedure.
Who may be able to join
- ASA physical status I or II women age between 25 and 45 y/o participating to receive TVOR
Who cannot join
- Allergy history to alfentanyl, propofol or lidocaine
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Anesthesiology, National Taiwan University Hospital
Taipei
About this study
Official title: Compare the Side Effects and Differences Awake Level of Propofol by Using Three TCI Formula of Anesthesia in TVOR Patients
This study is to find the fewer side effects formula of anesthesia for TVOR patients, to compare the BIS level during emergence and to find the correlation between BIS and transcutaneous carbon dioxide concentration.
Read the detailed description
Transvaginal oocyte retrieval (TVOR) is a procedure often used in infertility women . During the procedure, sedation, analgesia or anesthesia are often required. Propofol and alfentanyl are used for these patients for years, but these drugs are used in intravenous form and can be found in follicular fluid. Although further investigation needs to be undertaken to investigate any potential influence on fertilization and implantation rates, we anesthesiologist want to lower the use of drugs in these women. Target-controlled infusion (TCI) pumps can estimate and calculate the target and plasma concentration of propofol. By using these pumps , we can estimate the stable concentration of drugs. Besides, Bispectral index (BIS) monitor can help us to evaluate awareness or unarousable amnesia when we turn lower the drug use and keep patients amnesia during the procedure. Transcutaneous carbon dioxide monitor (tcCO2) can mimic the level of CO2 in patients by using noninvasive method. During anesthesia, CO2 will retain and may induce CO2 nacrosis, so we use these noninvasive method to help us to detect CO2 level preventing CO2 nacrosis and to see if there are any relationship with BIS.
- Keywords
- target control infusion, alfentanyl, propofol, BIS
- Medical subject headings
- Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | pure propofol by TCI pump with titration. | |
| 2 | 10ug/kg alfentanyl bolus and propofol TCI pump infusion with titration | |
| 3 | 20ug/kg alfentanyl bolus and propofol TCI pump infusion with titration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vital signs changes and side effects of drugs among groups
Measured: pre-anesthesia, post-anesthesia, and one hour post-anesthesia
Secondary outcomes (1)
Correlation between transcutaneous carbon dioxide and BIS (bispectral index)
Measured: From drug infusion stopped to patients awake (per minute)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2008 (estimated)
- Study startSep 2008
- Primary completionOct 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Bispectral IndexStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Prospective
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Chuen-shin Jeng, MD, MS, Study director, Visiting staff
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00760253
- Sponsor's protocol ID
- 200807070R
- Status last verified
- Dec 2008
- First submitted
- 25 Sep 2008
- Last updated
- 15 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Sherry E. Admixture of propofol and alfentanil. Use for intravenous sedation and analgesia during transvaginal oocyte retrieval. Anaesthesia. 1992 Jun;47(6):477-9. doi: 10.1111/j.1365-2044.1992.tb02268.x.
PubMed 1616081Eger EI, White PF, Bogetz MS. Clinical and economic factors important to anaesthetic choice for day-case surgery. Pharmacoeconomics. 2000 Mar;17(3):245-62. doi: 10.2165/00019053-200017030-00003.
PubMed 10947300Handa-Tsutsui F, Kodaka M. Effect of nitrous oxide on propofol requirement during target-controlled infusion for oocyte retrieval. Int J Obstet Anesth. 2007 Jan;16(1):13-6. doi: 10.1016/j.ijoa.2006.08.001. Epub 2006 Nov 27.
PubMed 17125991Soussis I, Boyd O, Paraschos T, Duffy S, Bower S, Troughton P, Lowe J, Grounds R. Follicular fluid levels of midazolam, fentanyl, and alfentanil during transvaginal oocyte retrieval. Fertil Steril. 1995 Nov;64(5):1003-7.
PubMed 7589618Chhajed PN, Rajasekaran R, Kaegi B, Chhajed TP, Pflimlin E, Leuppi J, Tamm M. Measurement of combined oximetry and cutaneous capnography during flexible bronchoscopy. Eur Respir J. 2006 Aug;28(2):386-90. doi: 10.1183/09031936.06.00088005. Epub 2006 Apr 26.
PubMed 16641122Turnbull D, Furlonger A, Andrzejowski J. The influence of changes in end-tidal carbon dioxide upon the Bispectral Index. Anaesthesia. 2008 May;63(5):458-62. doi: 10.1111/j.1365-2044.2007.05399.x.
PubMed 18412642Rigouzzo A, Girault L, Louvet N, Servin F, De-Smet T, Piat V, Seeman R, Murat I, Constant I. The relationship between bispectral index and propofol during target-controlled infusion anesthesia: a comparative study between children and young adults. Anesth Analg. 2008 Apr;106(4):1109-16, table of contents. doi: 10.1213/ane.0b013e318164f388.
PubMed 18349180Wang LP, McLoughlin P, Paech MJ, Kurowski I, Brandon EL. Low and moderate remifentanil infusion rates do not alter target-controlled infusion propofol concentrations necessary to maintain anesthesia as assessed by bispectral index monitoring. Anesth Analg. 2007 Feb;104(2):325-31. doi: 10.1213/01.ane.0000252966.03103.89.
PubMed 17242088Jeleazcov C, Ihmsen H, Schmidt J, Ammon C, Schwilden H, Schuttler J, Fechner J. Pharmacodynamic modelling of the bispectral index response to propofol-based anaesthesia during general surgery in children. Br J Anaesth. 2008 Apr;100(4):509-16. doi: 10.1093/bja/aem408. Epub 2008 Feb 12.
PubMed 18270231
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compare the Side Effects and Differences Awake Level of Propofol by Using Three TCI Formula of Anesthesia in TVOR Patients
- ClinicalTrials.gov ID
- NCT00760253
- Acronym / sponsor ID
- 200807070R
- Keywords
- target control infusion, alfentanyl, propofol, BIS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Oct 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 26 Sep 2008 (estimated)
- 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.
This study is to find the fewer side effects formula of anesthesia for TVOR patients, to compare the BIS level during emergence and to find the correlation between BIS and transcutaneous carbon dioxide concentration.
Detailed description
Transvaginal oocyte retrieval (TVOR) is a procedure often used in infertility women . During the procedure, sedation, analgesia or anesthesia are often required. Propofol and alfentanyl are used for these patients for years, but these drugs are used in intravenous form and can be found in follicular fluid. Although further investigation needs to be undertaken to investigate any potential influence on fertilization and implantation rates, we anesthesiologist want to lower the use of drugs in these women. Target-controlled infusion (TCI) pumps can estimate and calculate the target and plasma concentration of propofol. By using these pumps , we can estimate the stable concentration of drugs. Besides, Bispectral index (BIS) monitor can help us to evaluate awareness or unarousable amnesia when we turn lower the drug use and keep patients amnesia during the procedure. Transcutaneous carbon dioxide monitor (tcCO2) can mimic the level of CO2 in patients by using noninvasive method. During anesthesia, CO2 will retain and may induce CO2 nacrosis, so we use these noninvasive method to help us to detect CO2 level preventing CO2 nacrosis and to see if there are any relationship with BIS.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –pure propofol by TCI pump with titration. |
| 2 | – | –10ug/kg alfentanyl bolus and propofol TCI pump infusion with titration |
| 3 | – | –20ug/kg alfentanyl bolus and propofol TCI pump infusion with titration |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- ASA physical status I or II women age between 25 and 45 y/o participating to receive TVOR procedure.
Key inclusion criteria (1 listed)
- ASA physical status I or II women age between 25 and 45 y/o participating to receive TVOR
Key exclusion criteria (1 listed)
- Allergy history to alfentanyl, propofol or lidocaine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Vital signs changes and side effects of drugs among groups
Time frame: pre-anesthesia, post-anesthesia, and one hour post-anesthesia
1 secondary outcome
Correlation between transcutaneous carbon dioxide and BIS (bispectral index)
Time frame: From drug infusion stopped to patients awake (per minute)
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 15 Dec 2009.
- Background: PubMed 1616081Sherry E. Admixture of propofol and alfentanil. Use for intravenous sedation and analgesia during transvaginal oocyte retrieval. Anaesthesia. 1992 Jun;47(6):477-9. doi: 10.1111/j.1365-2044.1992.tb02268.x.
- Background: PubMed 10947300Eger EI, White PF, Bogetz MS. Clinical and economic factors important to anaesthetic choice for day-case surgery. Pharmacoeconomics. 2000 Mar;17(3):245-62. doi: 10.2165/00019053-200017030-00003.
- Background: PubMed 17125991Handa-Tsutsui F, Kodaka M. Effect of nitrous oxide on propofol requirement during target-controlled infusion for oocyte retrieval. Int J Obstet Anesth. 2007 Jan;16(1):13-6. doi: 10.1016/j.ijoa.2006.08.001. Epub 2006 Nov 27.
- Background: PubMed 7589618Soussis I, Boyd O, Paraschos T, Duffy S, Bower S, Troughton P, Lowe J, Grounds R. Follicular fluid levels of midazolam, fentanyl, and alfentanil during transvaginal oocyte retrieval. Fertil Steril. 1995 Nov;64(5):1003-7.
- Background: PubMed 16641122Chhajed PN, Rajasekaran R, Kaegi B, Chhajed TP, Pflimlin E, Leuppi J, Tamm M. Measurement of combined oximetry and cutaneous capnography during flexible bronchoscopy. Eur Respir J. 2006 Aug;28(2):386-90. doi: 10.1183/09031936.06.00088005. Epub 2006 Apr 26.
- Background: PubMed 18412642Turnbull D, Furlonger A, Andrzejowski J. The influence of changes in end-tidal carbon dioxide upon the Bispectral Index. Anaesthesia. 2008 May;63(5):458-62. doi: 10.1111/j.1365-2044.2007.05399.x.
- Background: PubMed 18349180Rigouzzo A, Girault L, Louvet N, Servin F, De-Smet T, Piat V, Seeman R, Murat I, Constant I. The relationship between bispectral index and propofol during target-controlled infusion anesthesia: a comparative study between children and young adults. Anesth Analg. 2008 Apr;106(4):1109-16, table of contents. doi: 10.1213/ane.0b013e318164f388.
- Background: PubMed 17242088Wang LP, McLoughlin P, Paech MJ, Kurowski I, Brandon EL. Low and moderate remifentanil infusion rates do not alter target-controlled infusion propofol concentrations necessary to maintain anesthesia as assessed by bispectral index monitoring. Anesth Analg. 2007 Feb;104(2):325-31. doi: 10.1213/01.ane.0000252966.03103.89.
- Background: PubMed 18270231Jeleazcov C, Ihmsen H, Schmidt J, Ammon C, Schwilden H, Schuttler J, Fechner J. Pharmacodynamic modelling of the bispectral index response to propofol-based anaesthesia during general surgery in children. Br J Anaesth. 2008 Apr;100(4):509-16. doi: 10.1093/bja/aem408. Epub 2008 Feb 12.
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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.
Chuen-shin Jeng, MD, MS study director
Visiting staff
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bispectral Index and Transcutaneous Carbon Dioxide, run by National Taiwan University Hospital 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 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 15 Dec 2009. 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?
Vital signs changes and side effects of drugs among groups (time frame: pre-anesthesia, post-anesthesia, and one hour post-anesthesia). 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 NCT00760253, which also lists 9 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 15 Dec 2009.