|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| 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: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
| 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 |
|---|---|
|
1: Active Comparator
Propofol-fentanyl combined anesthesia
|
Drug: Fentanyl Citrate
Combined anesthesia with propofol (2-2.5mg/kg) and fentanyl (5 μg)
|
|
2: Experimental
Propofol-butorphanol combined anesthesia
|
Drug: Butorphanol Tartrate
Combined anesthesia with propofol (2-2.5 mg/kg) and butorphanol (1mg)
|
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: | Nanjing Medical University ( XiaoFeng Shen ) |
| Study ID Numbers: | NMU-2008-FY10MZ31, NJFY0811-MZ02 |
| Study First Received: | November 20, 2008 |
| Last Updated: | July 14, 2009 |
| ClinicalTrials.gov Identifier: | NCT00795314 History of Changes |
| Health Authority: | China: Ethics Committee |
|
Opioids General anesthesia |
|
Anesthetics, Intravenous Respiratory System Agents Fentanyl Narcotic Antagonists Physiological Effects of Drugs Anesthetics Central Nervous System Depressants Narcotics Butorphanol Pharmacologic Actions Adjuvants, Anesthesia |
Anesthetics, General Sensory System Agents Therapeutic Uses Hypnotics and Sedatives Analgesics Peripheral Nervous System Agents Antitussive Agents Propofol Central Nervous System Agents Analgesics, Opioid |