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

Not Applicable

Completed

• Conditions: Post Operative Pain Management
• Interventions: Drug: Sufentanil (R30730, brand name Sufenta); Drug: Sufentanil (R30730, brand name Sufenta) + Morphine; Drug: Morphine

• Registration Number: NCT01917045
• Lead Sponsor: Peking University First Hospital

Brief Summary

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

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

Study Timeline

• Study Start: 2012-01
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Study First Submitted: 2013-06-14
• Status Verified: 2013-08
• Study First Submitted QC: 2013-08-03
• Last Update Submitted: 2013-08-03
• Study First Posted: 2013-08-06
• Last Update Posted: 2013-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 180

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
heigh body fat percentage	Sufentanil (R30730, brand name Sufenta)	body fat percentage more than 30%
heigh body fat percentage	Sufentanil (R30730, brand name Sufenta) + Morphine	body fat percentage more than 30%
low body fat percentage	Sufentanil (R30730, brand name Sufenta)	body fat percentage less than 30%
low body fat percentage	Sufentanil (R30730, brand name Sufenta) + Morphine	body fat percentage less than 30%
heigh body fat percentage	Morphine	body fat percentage more than 30%
low body fat percentage	Morphine	body fat percentage less than 30%

Primary Outcome Measures

Name	Time	Method
visual analogue pain scores	24hour	we evaluate visual analogue pain scores at different time points within 24 hours after surgery

Secondary Outcome Measures

Name	Time	Method
nausea & vomiting	24hour	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.