Propofol-butorphanol Anesthesia During Uterine Curettage

Study Overview
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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.

Official Title
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Propofol-butorphanol Combined Anesthesia During Uterine Curettage on Abortion

Conditions
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Abortion, Curettage

Intervention / Treatment
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* Drug: Fentanyl Citrate
* Drug: Butorphanol Tartrate


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Propofol-fentanyl combined anesthesia | Drug: Fentanyl Citrate<br>* Combined anesthesia with propofol (2-2.5mg/kg) and fentanyl (5 μg)<br>* Other names: Duragesic®;|
| Experimental: 2<br>Propofol-butorphanol combined anesthesia | Drug: Butorphanol Tartrate<br>* Combined anesthesia with propofol (2-2.5 mg/kg) and butorphanol (1mg)<br>* Other names: Torbutrol®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative awareness |  | During the whole process of anesthesia | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Opioids, General anesthesia