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Propofol-butorphanol Anesthesia During Uterine Curettage (PABADUC)

This study has been completed.
Sponsor:
Information provided by:
Nanjing Medical University
ClinicalTrials.gov Identifier:
NCT00795314
First received: November 20, 2008
Last updated: July 14, 2009
Last verified: July 2009
History of Changes
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Propofol-butorphanol Combined Anesthesia During Uterine Curettage on Abortion

Resource links provided by NLM:

U.S. FDA Resources

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
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®

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

Keywords provided by Nanjing Medical University:
Opioids
General anesthesia

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

ClinicalTrials.gov processed this record on June 18, 2013