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

NCT ID: NCT00760253

Last Updated: 2009-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

118 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-09-30

Study Completion Date

2008-12-31

Brief Summary

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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

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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.

Conditions

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Bispectral Index Transcutaneous Carbon Dioxide PONV Blood Pressure Heart Rate

Keywords

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target control infusion alfentanyl propofol BIS

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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1

pure propofol by TCI pump with titration.

No interventions assigned to this group

2

10ug/kg alfentanyl bolus and propofol TCI pump infusion with titration

No interventions assigned to this group

3

20ug/kg alfentanyl bolus and propofol TCI pump infusion with titration

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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NTUH

Principal Investigators

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Chuen-shin Jeng, MD, MS

Role: STUDY_DIRECTOR

Visiting staff

Locations

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Department of Anesthesiology, National Taiwan University Hospital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

References

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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.

Reference Type BACKGROUND
PMID: 1616081 (View on PubMed)

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. doi: 10.2165/00019053-200017030-00003.

Reference Type BACKGROUND
PMID: 10947300 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17125991 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7589618 (View on PubMed)

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. doi: 10.1183/09031936.06.00088005. Epub 2006 Apr 26.

Reference Type BACKGROUND
PMID: 16641122 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18412642 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18349180 (View on PubMed)

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. doi: 10.1213/01.ane.0000252966.03103.89.

Reference Type BACKGROUND
PMID: 17242088 (View on PubMed)

Jeleazcov 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.

Reference Type BACKGROUND
PMID: 18270231 (View on PubMed)

Other Identifiers

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200807070R

Identifier Type: -

Identifier Source: org_study_id