Propofol-butorphanol Anesthesia During Uterine Curettage (PABADUC)

Nanjing Medical University

Status and phase: Completed; Phase 4

Conditions: Abortion; Curettage

Treatments: Drug: Butorphanol Tartrate; Drug: Fentanyl Citrate

Study type: Interventional

Funder types: Other

Identifiers

NCT00795314

NJFY0811-MZ02

NMU-2008-FY10MZ31

Details and patient eligibility

About

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.

Enrollment: 150 patients

Sex: Female

Ages: 19 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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150 participants in 2 patient groups

1

Active Comparator group

Description:

Propofol-fentanyl combined anesthesia

Treatment:

Drug: Fentanyl Citrate

2

Experimental group

Description:

Propofol-butorphanol combined anesthesia

Treatment:

Drug: Butorphanol Tartrate