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Evaluation of Different Anesthesia for Uterine Curettage (EDAUC)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00733564
First Posted: August 13, 2008
Last Update Posted: March 31, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Nanjing Medical University
  Purpose
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.

Condition Intervention
Uterine Curettage Abortion, Induced Drug: Lidocaine Drug: Propofol Drug: Sevoflurane

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Anesthetic Efficacy of Propofol,Sevoflurane and Paracervical Block for Uterine Curettage

Resource links provided by NLM:


Further study details as provided by Nanjing Medical University:

Primary Outcome Measures:
  • Bispectral Index (BIS) value [ Time Frame: 0, 5, 10, 20, 30min after anesthesia ]

Secondary Outcome Measures:
  • Intraoperative awareness [ Time Frame: 0, 5, 10, 20, 30min after anesthesia ]
  • Vital signs [ Time Frame: 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 ]
  • Pain intensity [ Time Frame: 0, 5, 10, 20, 30min after surgical procedures ]
  • Cortisol level [ Time Frame: 30min before operation; 1 and 5min during operation ]
  • Side effects [ Time Frame: 30min after operation ]
  • Uterine bleeding [ Time Frame: 0min after completion of the operation; 1 hour after the operation ]

Estimated Enrollment: 150
Study Start Date: August 2008
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Paracervical block will be performed
Drug: Lidocaine
Paracervical injection of 2% Lidocaine to block associated nociception input
Other Name: 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 Name: Diprivan
Experimental: 3
Sevoflurane anesthesia will be performed
Drug: Sevoflurane
Sevoflurane 8% for anesthesia induction, 2-3% as the maintenance
Other Name: Sevorane

  Eligibility

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Ages Eligible for Study:   19 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00733564


Locations
China, Jiangsu
Nanjing Maternal and Child Health Care Hospital
Nanjing, Jiangsu, China, 210004
Sponsors and Collaborators
Nanjing Medical University
Investigators
Study Director: XiaoFeng Shen, MD Nanjing Medical University
  More Information

Responsible Party: XiaoFeng Shen, Nanjing Medical University
ClinicalTrials.gov Identifier: NCT00733564     History of Changes
Other Study ID Numbers: NMU-FY2008-209
NJFY0890-MZ12
First Submitted: August 11, 2008
First Posted: August 13, 2008
Last Update Posted: March 31, 2009
Last Verified: March 2009

Keywords provided by Nanjing Medical University:
Local anesthetic
Propofol
Sevoflurane

Additional relevant MeSH terms:
Anesthetics
Lidocaine
Propofol
Sevoflurane
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Platelet Aggregation Inhibitors
Anesthetics, Inhalation