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

This study has been completed.
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00760253
First received: September 25, 2008
Last updated: December 14, 2009
Last verified: December 2008
  Purpose

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
Bispectral Index
Transcutaneous Carbon Dioxide
PONV
Blood Pressure
Heart Rate

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • Vital signs changes and side effects of drugs among groups [ Time Frame: pre-anesthesia, post-anesthesia, and one hour post-anesthesia ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Correlation between transcutaneous carbon dioxide and BIS (bispectral index) [ Time Frame: From drug infusion stopped to patients awake (per minute) ] [ Designated as safety issue: No ]

Enrollment: 118
Study Start Date: September 2008
Study Completion Date: December 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
pure propofol by TCI pump with titration.
2
10ug/kg alfentanyl bolus and propofol TCI pump infusion with titration
3
20ug/kg alfentanyl bolus and propofol TCI pump infusion with titration

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.

  Eligibility

Ages Eligible for Study:   25 Years to 45 Years
Genders 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.

Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00760253

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

Publications:

Responsible Party: Jeng Chuen-shin/ visiting staff of Anesthesiology, NTUH, NTUH
ClinicalTrials.gov Identifier: NCT00760253     History of Changes
Other Study ID Numbers: 200807070R
Study First Received: September 25, 2008
Last Updated: December 14, 2009
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
target control infusion
alfentanyl
propofol
BIS

Additional relevant MeSH terms:
Alfentanil
Propofol
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Opioid
Hypnotics and Sedatives

ClinicalTrials.gov processed this record on July 24, 2014