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

Completed

• Conditions: Bispectral Index; Transcutaneous Carbon Dioxide; PONV; Blood Pressure; Heart Rate

• Registration Number: NCT00760253
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2008-09-25
• Study First Submitted QC: 2008-09-25
• Study First Posted: 2008-09-26
• Primary Completion: 2008-10
• Status Verified: 2008-12
• Study Completion: 2008-12
• Last Update Submitted: 2009-12-14
• Last Update Posted: 2009-12-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 118

Inclusion Criteria

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

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Exclusion Criteria

• Allergy history to alfentanyl, propofol or lidocaine

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Vital signs changes and side effects of drugs among groups	pre-anesthesia, post-anesthesia, and one hour post-anesthesia

Secondary Outcome Measures

Name	Time	Method
Correlation between transcutaneous carbon dioxide and BIS (bispectral index)	From drug infusion stopped to patients awake (per minute)

Trial Locations

Locations (1)

Department of Anesthesiology, National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan