Propofol-butorphanol Anesthesia During Uterine Curettage

NCT00795314 | Completed Phase 4 DMC

• 2 other identifiers: NMU-2008-FY10MZ31NJFY0811-MZ02
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Abortion; Curettage

Keywords

Opioids; General anesthesia

Outcome Measures

Primary Outcomes (1)

• Intraoperative awareness

  During the whole process of anesthesia

Secondary Outcomes (4)

• 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

Study Arms (2)

1

ACTIVE COMPARATOR

Propofol-fentanyl combined anesthesia

Drug: Fentanyl Citrate

2

EXPERIMENTAL

Propofol-butorphanol combined anesthesia

Drug: Butorphanol Tartrate

Interventions

Fentanyl Citrate DRUG

Combined anesthesia with propofol (2-2.5mg/kg) and fentanyl (5 μg)

Also known as: Actiq®, Fentora TM, Duragesic®

1

Butorphanol Tartrate DRUG

Combined anesthesia with propofol (2-2.5 mg/kg) and butorphanol (1mg)

Also known as: Torbugesic®, Torbutrol®

2

Eligibility Criteria

• Age: 19 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• ASA status I-II;
• Performing abortion operation (medical- or drug-induced);
• Requiring painless abortion;

You may not qualify if:

• \< 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.

Sponsors & Collaborators

• Nanjing Medical University: lead

Study Sites (1)

Nanjing Maternal and Child Health Care Hospital

Nanjing, Jiangsu, 210004, China

Location

MeSH Terms

Interventions

Fentanyl; Butorphanol

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• XiaoFeng Shen, MD

  Nanjing Medical University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 20, 2008
• First Posted: November 21, 2008
• Study Start: November 1, 2008
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: July 15, 2009

Record last verified: 2009-07

Locations

CN (1)