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Propofol-butorphanol Anesthesia During Uterine Curettage (PABADUC)

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.
 
ClinicalTrials.gov Identifier: NCT00795314
Recruitment Status : Completed
First Posted : November 21, 2008
Last Update Posted : July 15, 2009
Sponsor:
Information provided by:
Nanjing Medical University

Study Description
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Brief Summary:
Uterine curettage is usually performed under the anesthesia of propofol-fentanyl or para-cervical block,of which generally has significant incidence of respiratory depression which increases the demand on intraoperative monitoring, or has unavoidable insufficient blockade which results in intraoperative suffering of pain. Butorphanol is an analgesic with combined effects on mu and kappa opioid receptors leading to a role as analgesia and sedation. The investigators hypothesized that combined propofol with butorphanol during uterine curettage would produce optimal effectiveness of these two drugs by adding sedative and analgesic effects together. In addition, it would decrease the intraoperative consumption of propofol without increase the incidence of side effects. Furthermore, such combination would alleviate postoperative pain.

Condition or disease Intervention/treatment Phase
Abortion Curettage Drug: Fentanyl Citrate Drug: Butorphanol Tartrate Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Propofol-butorphanol Combined Anesthesia During Uterine Curettage on Abortion
Study Start Date : November 2008
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 1
Propofol-fentanyl combined anesthesia
 Drug: Fentanyl Citrate
Combined anesthesia with propofol (2-2.5mg/kg) and fentanyl (5 μg)
Other Names:
  • Actiq®
  • Fentora TM
  • Duragesic®
Experimental: 2
Propofol-butorphanol combined anesthesia
 Drug: Butorphanol Tartrate
Combined anesthesia with propofol (2-2.5 mg/kg) and butorphanol (1mg)
Other Names:
  • Torbugesic®
  • Torbutrol®


Outcome Measures
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Primary Outcome Measures :
  1. Intraoperative awareness [ Time Frame: During the whole process of anesthesia ]

Secondary Outcome Measures :
  1. Bispectral Index (BIS) value [ Time Frame: During the whole process of anesthesia ]
  2. Anesthetic consumptions [ Time Frame: From the start of operation to the end of surgical procedures ]
  3. Postoperative pain [ Time Frame: Since the end of the operation to 48 h follow-up. ]
  4. Postoperative bleeding [ Time Frame: Since the end of operation to 48 h follow-up ]

Eligibility Criteria
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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 drug-induced);
  • Requiring painless abortion;

Exclusion Criteria:

  • < 19yrs, and >= 45yrs;
  • 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 disorders.
Contacts and Locations
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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): NCT00795314


Locations
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China, Jiangsu
Nanjing Maternal and Child Health Care Hospital
Nanjing, Jiangsu, China, 210004
Sponsors and Collaborators
Nanjing Medical University
Investigators
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Study Chair: XiaoFeng Shen, MD Nanjing Medical University
More Information
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Responsible Party: XiaoFeng Shen, Nanjing Medical University
ClinicalTrials.gov Identifier: NCT00795314    
Other Study ID Numbers: NMU-2008-FY10MZ31
NJFY0811-MZ02
First Posted: November 21, 2008    Key Record Dates
Last Update Posted: July 15, 2009
Last Verified: July 2009
Keywords provided by Nanjing Medical University:
Opioids
General anesthesia
Additional relevant MeSH terms:
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Fentanyl
Butorphanol
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
 Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Antitussive Agents
Respiratory System Agents
Narcotic Antagonists