NCT00760253

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
118

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2008

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

September 25, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 26, 2008

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

December 15, 2009

Status Verified

December 1, 2008

Enrollment Period

1 month

First QC Date

September 25, 2008

Last Update Submit

December 14, 2009

Conditions

Bispectral IndexTranscutaneous Carbon DioxidePONVBlood PressureHeart Rate

Keywords

target control infusionalfentanylpropofolBIS

Outcome Measures

Primary Outcomes (1)

  • Vital signs changes and side effects of drugs among groups

    pre-anesthesia, post-anesthesia, and one hour post-anesthesia

Secondary Outcomes (1)

  • Correlation between transcutaneous carbon dioxide and BIS (bispectral index)

    From drug infusion stopped to patients awake (per minute)

Study Arms (3)

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

Eligibility Criteria

Age25 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Allergy history to alfentanyl, propofol or lidocaine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology, National Taiwan University Hospital

Taipei, Taiwan

Location

Related Publications (9)

  • Sherry E. Admixture of propofol and alfentanil. Use for intravenous sedation and analgesia during transvaginal oocyte retrieval. Anaesthesia. 1992 Jun;47(6):477-9. doi: 10.1111/j.1365-2044.1992.tb02268.x.

    PMID: 1616081BACKGROUND

  • Eger EI, White PF, Bogetz MS. Clinical and economic factors important to anaesthetic choice for day-case surgery. Pharmacoeconomics. 2000 Mar;17(3):245-62. doi: 10.2165/00019053-200017030-00003.

    PMID: 10947300BACKGROUND

  • Handa-Tsutsui F, Kodaka M. Effect of nitrous oxide on propofol requirement during target-controlled infusion for oocyte retrieval. Int J Obstet Anesth. 2007 Jan;16(1):13-6. doi: 10.1016/j.ijoa.2006.08.001. Epub 2006 Nov 27.

    PMID: 17125991BACKGROUND

  • Soussis I, Boyd O, Paraschos T, Duffy S, Bower S, Troughton P, Lowe J, Grounds R. Follicular fluid levels of midazolam, fentanyl, and alfentanil during transvaginal oocyte retrieval. Fertil Steril. 1995 Nov;64(5):1003-7.

    PMID: 7589618BACKGROUND

  • Chhajed PN, Rajasekaran R, Kaegi B, Chhajed TP, Pflimlin E, Leuppi J, Tamm M. Measurement of combined oximetry and cutaneous capnography during flexible bronchoscopy. Eur Respir J. 2006 Aug;28(2):386-90. doi: 10.1183/09031936.06.00088005. Epub 2006 Apr 26.

    PMID: 16641122BACKGROUND

  • Turnbull D, Furlonger A, Andrzejowski J. The influence of changes in end-tidal carbon dioxide upon the Bispectral Index. Anaesthesia. 2008 May;63(5):458-62. doi: 10.1111/j.1365-2044.2007.05399.x.

    PMID: 18412642BACKGROUND

  • Rigouzzo A, Girault L, Louvet N, Servin F, De-Smet T, Piat V, Seeman R, Murat I, Constant I. The relationship between bispectral index and propofol during target-controlled infusion anesthesia: a comparative study between children and young adults. Anesth Analg. 2008 Apr;106(4):1109-16, table of contents. doi: 10.1213/ane.0b013e318164f388.

    PMID: 18349180BACKGROUND

  • Wang LP, McLoughlin P, Paech MJ, Kurowski I, Brandon EL. Low and moderate remifentanil infusion rates do not alter target-controlled infusion propofol concentrations necessary to maintain anesthesia as assessed by bispectral index monitoring. Anesth Analg. 2007 Feb;104(2):325-31. doi: 10.1213/01.ane.0000252966.03103.89.

    PMID: 17242088BACKGROUND

  • Jeleazcov C, Ihmsen H, Schmidt J, Ammon C, Schwilden H, Schuttler J, Fechner J. Pharmacodynamic modelling of the bispectral index response to propofol-based anaesthesia during general surgery in children. Br J Anaesth. 2008 Apr;100(4):509-16. doi: 10.1093/bja/aem408. Epub 2008 Feb 12.

    PMID: 18270231BACKGROUND

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNauseaSigns and Symptoms, DigestiveSigns and SymptomsVomiting

Study Officials

  • Chuen-shin Jeng, MD, MS

    Visiting staff

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 25, 2008

First Posted

September 26, 2008

Study Start

September 1, 2008

Primary Completion

October 1, 2008

Study Completion

December 1, 2008

Last Updated

December 15, 2009

Record last verified: 2008-12

Locations

TW(1)