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Completed

NCT Number: NCT00795314

Propofol-butorphanol Anesthesia During Uterine Curettage

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.

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Key information

Conditions

Abortion Curettage

Age range

19 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Nanjing Maternal and Child Health Care Hospital

Nanjing, Jiangsu, 210004, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fentanyl Citrate

Drug

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

Other names: Actiq®, Fentora TM, Duragesic®

Butorphanol tartrate

Drug

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

Other names: Torbugesic®, Torbutrol®

Primary outcomes

  1. Intraoperative awareness

    Time frame: During the whole process of anesthesia

Secondary outcomes

  1. Bispectral Index (BIS) value

    Time frame: During the whole process of anesthesia

  2. Anesthetic consumptions

    Time frame: From the start of operation to the end of surgical procedures

  3. Postoperative pain

    Time frame: Since the end of the operation to 48 h follow-up.

  4. Postoperative bleeding

    Time frame: Since the end of operation to 48 h follow-up

Sponsors and collaborators

Lead sponsor

Nanjing Medical University

Other

Registry information

Official study title

Propofol-butorphanol Combined Anesthesia During Uterine Curettage on Abortion

Acronym: PABADUC

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Nov 21, 2008
Registry last updated
Jul 15, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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