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Propofol-butorphanol Anesthesia During Uterine Curettage (PABADUC)
This study has been completed.
First Received: November 20, 2008   Last Updated: July 14, 2009   History of Changes
Sponsor: Nanjing Medical University
Information provided by: Nanjing Medical University
ClinicalTrials.gov Identifier: NCT00795314
  Purpose

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 Intervention Phase
Abortion
Curettage
Drug: Fentanyl Citrate
Drug: Butorphanol Tartrate
Phase IV

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Propofol-butorphanol Combined Anesthesia During Uterine Curettage on Abortion

Resource links provided by NLM:


Further study details as provided by Nanjing Medical University:

Primary Outcome Measures:
  • Intraoperative awareness [ Time Frame: During the whole process of anesthesia ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Bispectral Index (BIS) value [ Time Frame: During the whole process of anesthesia ] [ Designated as safety issue: Yes ]
  • Anesthetic consumptions [ Time Frame: From the start of operation to the end of surgical procedures ] [ Designated as safety issue: Yes ]
  • Postoperative pain [ Time Frame: Since the end of the operation to 48 h follow-up. ] [ Designated as safety issue: Yes ]
  • Postoperative bleeding [ Time Frame: Since the end of operation to 48 h follow-up ] [ Designated as safety issue: Yes ]

Enrollment: 150
Study Start Date: November 2008
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Active Comparator
Propofol-fentanyl combined anesthesia
Drug: Fentanyl Citrate
Combined anesthesia with propofol (2-2.5mg/kg) and fentanyl (5 μg)
2: Experimental
Propofol-butorphanol combined anesthesia
Drug: Butorphanol Tartrate
Combined anesthesia with propofol (2-2.5 mg/kg) and butorphanol (1mg)

  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 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00795314

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

No publications provided

Responsible Party: Nanjing Medical University ( XiaoFeng Shen )
Study ID Numbers: NMU-2008-FY10MZ31, NJFY0811-MZ02
Study First Received: November 20, 2008
Last Updated: July 14, 2009
ClinicalTrials.gov Identifier: NCT00795314     History of Changes
Health Authority: China: Ethics Committee

Keywords provided by Nanjing Medical University:
Opioids
General anesthesia

Additional relevant MeSH terms:
Anesthetics, Intravenous
Respiratory System Agents
Fentanyl
Narcotic Antagonists
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Narcotics
Butorphanol
Pharmacologic Actions
Adjuvants, Anesthesia
Anesthetics, General
Sensory System Agents
Therapeutic Uses
Hypnotics and Sedatives
Analgesics
Peripheral Nervous System Agents
Antitussive Agents
Propofol
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on February 08, 2010