Propofol-butorphanol Anesthesia During Uterine Curettage

Abortion Clinical Trial

— PABADUC  

Official title:

Propofol-butorphanol Combined Anesthesia During Uterine Curettage on Abortion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00795314
• Other study ID #: NMU-2008-FY10MZ31
• Secondary ID: NJFY0811-MZ02
• Status: Completed
• Phase: Phase 4
• First received: November 20, 2008
• Last updated: July 14, 2009
• Start date: November 2008
• Est. completion date: July 2009

Study information

• Verified date: July 2009
• Source: Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abortion
• Curettage

Intervention

Drug:
• Fentanyl Citrate
Combined anesthesia with propofol (2-2.5mg/kg) and fentanyl (5 µg)
• Butorphanol Tartrate
Combined anesthesia with propofol (2-2.5 mg/kg) and butorphanol (1mg)

Locations

Country	Name	City	State
China	Nanjing Maternal and Child Health Care Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraoperative awareness		During the whole process of anesthesia	Yes
Secondary	Bispectral Index (BIS) value		During the whole process of anesthesia	Yes
Secondary	Anesthetic consumptions		From the start of operation to the end of surgical procedures	Yes
Secondary	Postoperative pain		Since the end of the operation to 48 h follow-up.	Yes
Secondary	Postoperative bleeding		Since the end of operation to 48 h follow-up	Yes