Propofol-butorphanol Anesthesia During Uterine Curettage - Full Text View

Purpose

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.

Condition	Intervention	Phase
Abortion Curettage	Drug: Fentanyl Citrate Drug: Butorphanol Tartrate	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Propofol-butorphanol Combined Anesthesia During Uterine Curettage on Abortion

Resource links provided by NLM:

Drug Information available for: Fentanyl Fentanyl citrate Propofol Butorphanol tartrate

U.S. FDA Resources

Further study details as provided by Nanjing Medical University:

Primary Outcome Measures:

Intraoperative awareness [ Time Frame: During the whole process of anesthesia ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Bispectral Index (BIS) value [ Time Frame: During the whole process of anesthesia ] [ Designated as safety issue: Yes ]
Anesthetic consumptions [ Time Frame: From the start of operation to the end of surgical procedures ] [ Designated as safety issue: Yes ]
Postoperative pain [ Time Frame: Since the end of the operation to 48 h follow-up. ] [ Designated as safety issue: Yes ]
Postoperative bleeding [ Time Frame: Since the end of operation to 48 h follow-up ] [ Designated as safety issue: Yes ]


Enrollment:	150
Study Start Date:	November 2008
Study Completion Date:	July 2009
Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 Propofol-fentanyl combined anesthesia	Drug: Fentanyl Citrate Combined anesthesia with propofol (2-2.5mg/kg) and fentanyl (5 μg) Other Names: Actiq® Fentora TM Duragesic®
Experimental: 2 Propofol-butorphanol combined anesthesia	Drug: Butorphanol Tartrate Combined anesthesia with propofol (2-2.5 mg/kg) and butorphanol (1mg) Other Names: Torbugesic® Torbutrol®

Eligibility


Ages Eligible for Study:	19 Years to 45 Years (Adult)
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT00795314

Locations


China, Jiangsu
Nanjing Maternal and Child Health Care Hospital
Nanjing, Jiangsu, China, 210004

Sponsors and Collaborators

Nanjing Medical University

Investigators


Study Chair:	XiaoFeng Shen, MD	Nanjing Medical University

More Information


Responsible Party:	XiaoFeng Shen, Nanjing Medical University
ClinicalTrials.gov Identifier:	NCT00795314 History of Changes
Other Study ID Numbers:	NMU-2008-FY10MZ31 NJFY0811-MZ02
Study First Received:	November 20, 2008
Last Updated:	July 14, 2009
Health Authority:	China: Ethics Committee

Keywords provided by Nanjing Medical University:


Opioids General anesthesia

Additional relevant MeSH terms:


Anesthetics Propofol Fentanyl Butorphanol Central Nervous System Depressants Physiological Effects of Drugs Hypnotics and Sedatives Anesthetics, Intravenous Anesthetics, General	Analgesics, Opioid Narcotics Analgesics Sensory System Agents Peripheral Nervous System Agents Adjuvants, Anesthesia Antitussive Agents Respiratory System Agents Narcotic Antagonists

ClinicalTrials.gov processed this record on September 29, 2016

Propofol-butorphanol Anesthesia During Uterine Curettage (PABADUC)