Different Lipid Soluble Opioids for Gynecologic Laparoscopic Surgery Postoperative Patient-controlled Analgesia

Study Overview
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Brief Summary
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The investigators noticed that Body Fat Ratio might have great influence on the efficacy of different lipid soluble anesthetics. The objective of this clinical trial was to compare the effect of that Body Fat Ratio on the efficacy of different lipid soluble anesthetics.

Detailed Description
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The objective of this clinical trial was to compare the effect of that Body Fat Ratio on the efficacy of different lipid soluble anesthetics.

Official Title
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Different Lipid Soluble Opioids for Gynecologic Laparoscopic Surgery Postoperative Patient-controlled Analgesia --- a Double Blind Randomized Study

Conditions
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Post Operative Pain Management

Intervention / Treatment
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* Drug: Sufentanil (R30730, brand name Sufenta)
* Drug: Sufentanil (R30730, brand name Sufenta) + Morphine
* Drug: Morphine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society of Anesthesiologists grade I-II adults aged over 20 and below 50 years old, non-smoker, with normal hepatic and renal function. Exclusion Criteria: smoker , any kind of mental disorder or history use of analgesics for more than 10 consecutive days, asthma; and those with digestion tract disorder who would get nausea or vomiting much more easily than normal people.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: low body fat percentage<br>body fat percentage less than 30% | Drug: Sufentanil (R30730, brand name Sufenta)<br>* sufentanil 1ug/ml<br>Drug: Sufentanil (R30730, brand name Sufenta) + Morphine<br>* sufentanil 0.5ug/ml+morphine 0.25mg/ml<br>Drug: Morphine<br>* morphine 0. 5mg/ml<br>|
| Experimental: heigh body fat percentage<br>body fat percentage more than 30% | Drug: Sufentanil (R30730, brand name Sufenta)<br>* sufentanil 1ug/ml<br>Drug: Sufentanil (R30730, brand name Sufenta) + Morphine<br>* sufentanil 0.5ug/ml+morphine 0.25mg/ml<br>Drug: Morphine<br>* morphine 0. 5mg/ml<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visual analogue pain scores | we evaluate visual analogue pain scores at different time points within 24 hours after surgery | 24hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| nausea & vomiting | we evaluate nausea & vomiting at different time points within 24 hours after surgery. we ask the patient if she feel nausea or/and occured vomit, if so, 1 time will be recorded in the time point for incidence. | 24hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sufentanil, postoperative pain control, body fat percentage, gynecology laparoscopic surgery, lipid solubility, morphine