Propofol-butorphanol Anesthesia During Uterine Curettage

Phase 4

Completed

• Conditions: Abortion; Curettage
• Interventions: Drug: Fentanyl Citrate; Drug: Butorphanol Tartrate

• Registration Number: NCT00795314
• Lead Sponsor: Nanjing Medical University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11
• Study First Submitted: 2008-11-20
• Study First Submitted QC: 2008-11-20
• Study First Posted: 2008-11-21
• Status Verified: 2009-07
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Last Update Submitted: 2009-07-14
• Last Update Posted: 2009-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 150

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Fentanyl Citrate	Propofol-fentanyl combined anesthesia
2	Butorphanol Tartrate	Propofol-butorphanol combined anesthesia

Primary Outcome Measures

Name	Time	Method
Intraoperative awareness	During the whole process of anesthesia

Secondary Outcome Measures

Name	Time	Method
Bispectral Index (BIS) value	During the whole process of anesthesia
Anesthetic consumptions	From the start of operation to the end of surgical procedures
Postoperative pain	Since the end of the operation to 48 h follow-up.
Postoperative bleeding	Since the end of operation to 48 h follow-up

Trial Locations

Locations (1)

Nanjing Maternal and Child Health Care Hospital; 🇨🇳 Nanjing, Jiangsu, China