Clinical trial NCT00760253: Compare the Side Effects and Difference Awake Level of Three TCI Propofol Formula in TVOR Patients
Official title: Compare the Side Effects and Differences Awake Level of Propofol by Using Three TCI Formula of Anesthesia in TVOR Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bispectral Index
Transcutaneous Carbon Dioxide
PONV
Blood Pressure
Heart Rate
Keywords: target control infusion
alfentanyl
propofol
BIS
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2008-09-26
Enrollment: 118
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: ASA physical status I or II women age between 25 and 45 y/o participating to receive TVOR procedure.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* ASA physical status I or II women age between 25 and 45 y/o participating to receive TVOR

Exclusion Criteria:

* Allergy history to alfentanyl, propofol or lidocaine

Primary outcomes:
measure: Vital signs changes and side effects of drugs among groups
timeFrame: pre-anesthesia, post-anesthesia, and one hour post-anesthesia
Secondary outcomes:
measure: Correlation between transcutaneous carbon dioxide and BIS (bispectral index)
timeFrame: From drug infusion stopped to patients awake (per minute)
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Department of Anesthesiology, National Taiwan University Hospital
Study officials:
affiliation: Visiting staff
name: Chuen-shin Jeng, MD, MS
role: STUDY_DIRECTOR
References:
citation: 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.
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citation: Handa-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.
citation: Soussis 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.
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citation: Rigouzzo 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.
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