Propofol-butorphanol Anesthesia During Uterine Curettage (PABADUC)

July 14, 2009 updated by: Nanjing Medical University

Propofol-butorphanol Combined Anesthesia During Uterine Curettage on Abortion

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210004
        • Nanjing Maternal and Child Health Care Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 45 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / 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®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Intraoperative awareness
Time Frame: During the whole process of anesthesia
During the whole process of anesthesia

Secondary Outcome Measures

Outcome Measure
Time Frame
Bispectral Index (BIS) value
Time Frame: During the whole process of anesthesia
During the whole process of anesthesia
Anesthetic consumptions
Time Frame: From the start of operation to the end of surgical procedures
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.
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
Since the end of operation to 48 h follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanjing Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (ACTUAL)

July 1, 2009

Study Completion (ACTUAL)

July 1, 2009

Study Registration Dates

First Submitted

November 20, 2008

First Submitted That Met QC Criteria

November 20, 2008

First Posted (ESTIMATE)

November 21, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

July 15, 2009

Last Update Submitted That Met QC Criteria

July 14, 2009

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NMU-2008-FY10MZ31
  • NJFY0811-MZ02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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