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

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

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.

Study Overview

• Status: Completed
• Conditions: Post Operative Pain Management
• Intervention / Treatment: Drug: Sufentanil (R30730, brand name Sufenta); Drug: Sufentanil (R30730, brand name Sufenta) + Morphine; Drug: Morphine

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 Type: Interventional
• Enrollment (Actual): 180
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Peking University First Hospital
• Investigators: Principal Investigator: zhou yan, MD, PKU 1st hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): March 1, 2013
• Study Completion (Actual): March 1, 2013

Study Registration Dates

• First Submitted: June 14, 2013
• First Submitted That Met QC Criteria: August 3, 2013
• First Posted (Estimate): August 6, 2013

Study Record Updates

• Last Update Posted (Estimate): August 6, 2013
• Last Update Submitted That Met QC Criteria: August 3, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: morphine; sufentanil; postoperative pain control; body fat percentage; gynecology laparoscopic surgery; lipid solubility
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Morphine; Sufentanil; Dsuvia
• Other Study ID Numbers: LSOPCA-021