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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00760253
Recruitment Status : Completed
First Posted : September 26, 2008
Last Update Posted : December 15, 2009
Information provided by:
National Taiwan University Hospital

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.

Condition or disease
Bispectral Index Transcutaneous Carbon Dioxide PONV Blood Pressure Heart Rate

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.

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Study Type : Observational
Actual Enrollment : 118 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Compare the Side Effects and Differences Awake Level of Propofol by Using Three TCI Formula of Anesthesia in TVOR Patients
Study Start Date : September 2008
Actual Primary Completion Date : October 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Propofol

pure propofol by TCI pump with titration.
10ug/kg alfentanyl bolus and propofol TCI pump infusion with titration
20ug/kg alfentanyl bolus and propofol TCI pump infusion with titration

Primary Outcome Measures :
  1. Vital signs changes and side effects of drugs among groups [ Time Frame: pre-anesthesia, post-anesthesia, and one hour post-anesthesia ]

Secondary Outcome Measures :
  1. Correlation between transcutaneous carbon dioxide and BIS (bispectral index) [ Time Frame: From drug infusion stopped to patients awake (per minute) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00760253

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Department of Anesthesiology, National Taiwan University Hospital
Taipei, Taiwan
Sponsors and Collaborators
National Taiwan University Hospital
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Study Director: Chuen-shin Jeng, MD, MS Visiting staff

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Responsible Party: Jeng Chuen-shin/ visiting staff of Anesthesiology, NTUH, NTUH Identifier: NCT00760253    
Other Study ID Numbers: 200807070R
First Posted: September 26, 2008    Key Record Dates
Last Update Posted: December 15, 2009
Last Verified: December 2008
Keywords provided by National Taiwan University Hospital:
target control infusion