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Evaluation of Different Anesthesia for Uterine Curettage (EDAUC)

This study has been completed.
Sponsor:
Information provided by:
Nanjing Medical University
ClinicalTrials.gov Identifier:
NCT00733564
First received: August 11, 2008
Last updated: March 30, 2009
Last verified: March 2009

August 11, 2008
March 30, 2009
August 2008
March 2009   (final data collection date for primary outcome measure)
Bispectral Index (BIS) value [ Time Frame: 0, 5, 10, 20, 30min after anesthesia ] [ Designated as safety issue: Yes ]
Bispectral Index (BIS) value [ Time Frame: During the whole process of anesthesia ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00733564 on ClinicalTrials.gov Archive Site
  • Intraoperative awareness [ Time Frame: 0, 5, 10, 20, 30min after anesthesia ] [ Designated as safety issue: Yes ]
  • Vital signs [ Time Frame: 0, 5, 10, 15, 20, 25, 30min after anesthesia ] [ Designated as safety issue: Yes ]
  • Arterial blood gas analysis [ Time Frame: 5min before operation; 1min and 5min after beginning of the operation ] [ Designated as safety issue: Yes ]
  • Pain intensity [ Time Frame: 0, 5, 10, 20, 30min after surgical procedures ] [ Designated as safety issue: Yes ]
  • Cortisol level [ Time Frame: 30min before operation; 1 and 5min during operation ] [ Designated as safety issue: No ]
  • Side effects [ Time Frame: 30min after operation ] [ Designated as safety issue: Yes ]
  • Uterine bleeding [ Time Frame: 0min after completion of the operation; 1 hour after the operation ] [ Designated as safety issue: Yes ]
  • Intraoperative awareness [ Time Frame: During the whole process of anesthesia ] [ Designated as safety issue: Yes ]
  • Vital signs [ Time Frame: During the whole period of study ] [ Designated as safety issue: Yes ]
  • Arterial blood gas analysis [ Time Frame: 5min before operation; 1min and 5min after beginning of the operation ] [ Designated as safety issue: Yes ]
  • Pain intensity [ Time Frame: At the time of the awareness recovered after operation ] [ Designated as safety issue: Yes ]
  • Cortisol level [ Time Frame: 30min before operation; 1 and 5min during operation ] [ Designated as safety issue: No ]
  • Side effects [ Time Frame: After operation ] [ Designated as safety issue: Yes ]
  • Uterine bleeding [ Time Frame: During the period of anesthesia; 1 hour after the operation ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Evaluation of Different Anesthesia for Uterine Curettage
Evaluation of the Anesthetic Efficacy of Propofol,Sevoflurane and Paracervical Block for Uterine Curettage

Anesthesia during uterine curettage is a problem. Paracervical block is used in general for such an operation, though, the anesthetic efficacy is incomplete. Propofol is the short-lasting intravenous anesthetic administrated popularly. Sevoflurane is a new inhalational anesthetic well-known for it's "easy come, easy go" property. The investigators hypothesized that propofol, sevoflurane and paracervical block had different anesthetic efficacy during uterine curettage. Which one is the optimal selection for such operation needed to be evaluated.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Uterine Curettage
  • Abortion, Induced
  • Drug: Lidocaine
    Paracervical injection of 2% Lidocaine to block associated nociception input
    Other Name: Lignocaine
  • Drug: Propofol
    Propofol 3mg/kg will be injected intravenously; 1 mg/kg will be added additionally for incomplete anesthesia
    Other Name: Diprivan
  • Drug: Sevoflurane
    Sevoflurane 8% for anesthesia induction, 2-3% as the maintenance
    Other Name: Sevorane
  • Active Comparator: 1
    Paracervical block will be performed
    Intervention: Drug: Lidocaine
  • Experimental: 2
    Propofol anesthesia will be performed
    Intervention: Drug: Propofol
  • Experimental: 3
    Sevoflurane anesthesia will be performed
    Intervention: Drug: Sevoflurane
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
March 2009
March 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • ASA status I-II
  • Performing abortion operation (medical- or surgical)
  • Requiring painless abortion

Exclusion Criteria:

  • < 19 yrs, and >=45 yrs
  • History of central active drugs administration
  • Drug abuse
  • Hypertension
  • Diabetes
  • Any other chronic diseases
  • Allergy to the study drugs
  • Habit of over-volume alcohol drinking
  • Records of history of centrally active drug use and psychiatry
  • Any organic disorder
Female
19 Years to 45 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00733564
NMU-FY2008-209, NJFY0890-MZ12
Yes
XiaoFeng Shen, Nanjing Medical University
Nanjing Medical University
Not Provided
Study Director: XiaoFeng Shen, MD Nanjing Medical University
Nanjing Medical University
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP