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Completed

NCT Number: NCT00760253

Compare the Side Effects and Difference Awake Level of Three TCI Propofol Formula 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.

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Key information

Age range

25 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Department of Anesthesiology, National Taiwan University Hospital

Taipei, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Vital signs changes and side effects of drugs among groups

    Time frame: pre-anesthesia, post-anesthesia, and one hour post-anesthesia

Secondary outcomes

  1. Correlation between transcutaneous carbon dioxide and BIS (bispectral index)

    Time frame: From drug infusion stopped to patients awake (per minute)

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Sep 26, 2008
Registry last updated
Dec 15, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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