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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00760253

Enrollment

118

Registered

2008-09-26

Start date

2008-09-30

Completion date

2008-12-31

Last updated

2009-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

target control infusion, alfentanyl, propofol, BIS

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

25 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

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

Countries

Taiwan

Outcome results