Compare the Side Effects and Difference Awake Level of Three TCI Propofol Formula in TVOR Patients

Blood Pressure Clinical Trial

Official title:

Compare the Side Effects and Differences Awake Level of Propofol by Using Three TCI Formula of Anesthesia in TVOR Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00760253
• Other study ID #: 200807070R
• Status: Completed
• Phase: N/A
• First received: September 25, 2008
• Last updated: December 14, 2009
• Start date: September 2008
• Est. completion date: December 2008

Study information

• Verified date: December 2008
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: December 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 45 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bispectral Index
• Blood Pressure
• Heart Rate
• PONV
• Transcutaneous Carbon Dioxide

Locations

Country	Name	City	State
Taiwan	Department of Anesthesiology, National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (9)

Chhajed 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. Epub 2006 Apr 26. — View Citation

Eger EI, White PF, Bogetz MS. Clinical and economic factors important to anaesthetic choice for day-case surgery. Pharmacoeconomics. 2000 Mar;17(3):245-62. Review. — View 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. Epub 2006 Nov 27. — View Citation

Jeleazcov C, Ihmsen H, Schmidt J, Ammon C, Schwilden H, Schüttler 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. — View 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. — View 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. — View 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. — View Citation

Turnbull 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. — View Citation

Wang 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vital signs changes and side effects of drugs among groups		pre-anesthesia, post-anesthesia, and one hour post-anesthesia	No
Secondary	Correlation between transcutaneous carbon dioxide and BIS (bispectral index)		From drug infusion stopped to patients awake (per minute)	No