Evaluation of Different Anesthesia for Uterine Curettage (EDAUC)

March 30, 2009 updated by: Nanjing Medical University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210004
        • Nanjing Maternal and Child Health Care Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Paracervical block will be performed
Drug: Lidocaine
Paracervical injection of 2% Lidocaine to block associated nociception input
Other Names:
  • Lignocaine
Experimental: 2
Propofol anesthesia will be performed
Drug: Propofol
Propofol 3mg/kg will be injected intravenously; 1 mg/kg will be added additionally for incomplete anesthesia
Other Names:
  • Diprivan
Experimental: 3
Sevoflurane anesthesia will be performed
Drug: Sevoflurane
Sevoflurane 8% for anesthesia induction, 2-3% as the maintenance
Other Names:
  • Sevorane

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Bispectral Index (BIS) value
Time Frame: 0, 5, 10, 20, 30min after anesthesia
0, 5, 10, 20, 30min after anesthesia

Secondary Outcome Measures

Outcome Measure
Time Frame
Intraoperative awareness
Time Frame: 0, 5, 10, 20, 30min after anesthesia
0, 5, 10, 20, 30min after anesthesia
Vital signs
Time Frame: 0, 5, 10, 15, 20, 25, 30min after anesthesia
0, 5, 10, 15, 20, 25, 30min after anesthesia
Arterial blood gas analysis
Time Frame: 5min before operation; 1min and 5min after beginning of the operation
5min before operation; 1min and 5min after beginning of the operation
Pain intensity
Time Frame: 0, 5, 10, 20, 30min after surgical procedures
0, 5, 10, 20, 30min after surgical procedures
Cortisol level
Time Frame: 30min before operation; 1 and 5min during operation
30min before operation; 1 and 5min during operation
Side effects
Time Frame: 30min after operation
30min after operation
Uterine bleeding
Time Frame: 0min after completion of the operation; 1 hour after the operation
0min after completion of the operation; 1 hour after the operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanjing Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

August 11, 2008

First Submitted That Met QC Criteria

August 12, 2008

First Posted (Estimate)

August 13, 2008

Study Record Updates

Last Update Posted (Estimate)

March 31, 2009

Last Update Submitted That Met QC Criteria

March 30, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NMU-FY2008-209
  • NJFY0890-MZ12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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