Propofol-butorphanol Anesthesia During Uterine Curettage

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2009-07-31

Brief Summary

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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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Detailed Description

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Conditions

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Abortion Curettage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Propofol-fentanyl combined anesthesia

Group Type ACTIVE_COMPARATOR

Fentanyl Citrate

Intervention Type DRUG

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

2

Propofol-butorphanol combined anesthesia

Group Type EXPERIMENTAL

Butorphanol Tartrate

Intervention Type DRUG

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

Interventions

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Fentanyl Citrate

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

Intervention Type DRUG

Butorphanol Tartrate

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

Intervention Type DRUG

Other Intervention Names

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Actiq® Fentora TM Duragesic® Torbugesic® Torbutrol®

Eligibility Criteria

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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.

Minimum Eligible Age

19 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No