Back to resultsDifferent Lipid Soluble Opioids for Gynecologic Laparoscopic Surgery Postoperative Patient-controlled Analgesia
Primary Purpose
Post Operative Pain Management
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Sufentanil (R30730, brand name Sufenta)
Sufentanil (R30730, brand name Sufenta) + Morphine
Morphine
Sponsored by
About this trial
This is an interventional treatment trial for Post Operative Pain Management focused on measuring sufentanil, morphine, postoperative pain control, body fat percentage, gynecology laparoscopic surgery, lipid solubility
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
low body fat percentage
heigh body fat percentage
Arm Description
body fat percentage less than 30%
body fat percentage more than 30%
Outcomes
Primary Outcome Measures
visual analogue pain scores
we evaluate visual analogue pain scores at different time points within 24 hours after surgery
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01917045
First Posted
June 14, 2013
Last Updated
August 3, 2013
Sponsor
Peking University First Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01917045
Brief Title
Different Lipid Soluble Opioids for Gynecologic Laparoscopic Surgery Postoperative Patient-controlled Analgesia
Official Title
Different Lipid Soluble Opioids for Gynecologic Laparoscopic Surgery Postoperative Patient-controlled Analgesia --- a Double Blind Randomized Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University First Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain Management
Keywords
sufentanil, morphine, postoperative pain control, body fat percentage, gynecology laparoscopic surgery, lipid solubility
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
180 (Actual)
8. Arms, Groups, and Interventions
Arm Title
low body fat percentage
Arm Type
Experimental
Arm Description
body fat percentage less than 30%
Arm Title
heigh body fat percentage
Arm Type
Experimental
Arm Description
body fat percentage more than 30%
Intervention Type
Drug
Intervention Name(s)
Sufentanil (R30730, brand name Sufenta)
Intervention Description
sufentanil 1ug/ml
Intervention Type
Drug
Intervention Name(s)
Sufentanil (R30730, brand name Sufenta) + Morphine
Intervention Description
sufentanil 0.5ug/ml+morphine 0.25mg/ml
Intervention Type
Drug
Intervention Name(s)
Morphine
Intervention Description
morphine 0. 5mg/ml
Primary Outcome Measure Information:
Title
visual analogue pain scores
Description
we evaluate visual analogue pain scores at different time points within 24 hours after surgery
Time Frame
24hour
Secondary Outcome Measure Information:
Title
nausea & vomiting
Description
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.
Time Frame
24hour
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
zhou yan, MD
Organizational Affiliation
PKU 1st hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Different Lipid Soluble Opioids for Gynecologic Laparoscopic Surgery Postoperative Patient-controlled Analgesia
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