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| 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: | 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 |
| 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:
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|
Experimental: 2
Propofol-butorphanol combined anesthesia
|
Drug: Butorphanol Tartrate
Combined anesthesia with propofol (2-2.5 mg/kg) and butorphanol (1mg)
Other Names:
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Eligibility| Ages Eligible for Study: | 19 Years to 45 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| China, Jiangsu | |
| Nanjing Maternal and Child Health Care Hospital | |
| Nanjing, Jiangsu, China, 210004 | |
| 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 |
| Health Authority: | China: Ethics Committee |
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Opioids General anesthesia |
|
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 |