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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
  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
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

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 ]

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

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   (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Keywords provided by Nanjing Medical University:
Opioids
General anesthesia

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

ClinicalTrials.gov processed this record on August 17, 2017