Propofol-Butorphanol Anesthesia During Uterine Curettage
Information source: Nanjing Medical University
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Abortion; Curettage
Intervention: Fentanyl Citrate (Drug); Butorphanol Tartrate (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Nanjing Medical University Official(s) and/or principal investigator(s):
XiaoFeng Shen, MD, Study Chair, Affiliation: Nanjing Medical University
Overall contact:
FuZhou Wang, MD, Phone: 86-25-84460777, Ext: 3301, Email: zfwang50@gmail.com
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.
Clinical Details
Official title: Propofol-Butorphanol Combined Anesthesia During Uterine Curettage on Abortion
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Intraoperative awareness
Secondary outcome: Bispectral Index (BIS) valueAnesthetic consumptions Postoperative pain Postoperative bleeding
Eligibility
Minimum age: 19 Years.
Maximum age: 45 Years.
Gender(s): Female.
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.
Locations and Contacts
FuZhou Wang, MD, Phone: 86-25-84460777, Ext: 3301, Email: zfwang50@gmail.com
Nanjing Maternal and Child Health Care Hospital, Nanjing, Jiangsu 210004, China; Recruiting
YuZhu Peng, MD, Phone: 86-25-84460777, Ext: 1508, Email: pyz1131@hotmail.com
XiRong Guo, MD, Phone: 86-25-84460777, Ext: 1508, Email: xrguonjmueducn@yahoo.com.cn
YuSheng Liu, MD, Sub-Investigator
Additional Information
Starting date: November 2008
Ending date: June 2009
Last updated: February 10, 2009
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