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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
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

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

Ages Eligible for Study:   19 Years to 45 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: XiaoFeng Shen, Nanjing Medical University
ClinicalTrials.gov Identifier: NCT00733564     History of Changes
Other Study ID Numbers: NMU-FY2008-209, NJFY0890-MZ12
Study First Received: August 11, 2008
Last Updated: March 30, 2009
Health Authority: China: Ethics Committee

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
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Local
 Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Cardiovascular Agents
Anesthetics, Intravenous
Anesthetics, General
Hypnotics and Sedatives
Platelet Aggregation Inhibitors
Hematologic Agents
Anesthetics, Inhalation

ClinicalTrials.gov processed this record on May 19, 2013