NCT01917045

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2012

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 14, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 6, 2013

Completed
Last Updated

August 6, 2013

Status Verified

August 1, 2013

Enrollment Period

1.2 years

First QC Date

June 14, 2013

Last Update Submit

August 3, 2013

Conditions

Keywords

sufentanilmorphinepostoperative pain controlbody fat percentagegynecology laparoscopic surgerylipid solubility

Outcome Measures

Primary Outcomes (1)

  • visual analogue pain scores

    we evaluate visual analogue pain scores at different time points within 24 hours after surgery

    24hour

Secondary Outcomes (1)

  • nausea & vomiting

    24hour

Study Arms (2)

low body fat percentage

EXPERIMENTAL

body fat percentage less than 30%

Drug: Sufentanil (R30730, brand name Sufenta)Drug: Sufentanil (R30730, brand name Sufenta) + MorphineDrug: Morphine

heigh body fat percentage

EXPERIMENTAL

body fat percentage more than 30%

Drug: Sufentanil (R30730, brand name Sufenta)Drug: Sufentanil (R30730, brand name Sufenta) + MorphineDrug: Morphine

Interventions

sufentanil 1ug/ml

heigh body fat percentagelow body fat percentage

sufentanil 0.5ug/ml+morphine 0.25mg/ml

heigh body fat percentagelow body fat percentage

morphine 0. 5mg/ml

heigh body fat percentagelow body fat percentage

Eligibility Criteria

Age20 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • American Society of Anesthesiologists grade I-II
  • adults aged over 20 and below 50 years old,
  • non-smoker,
  • with normal hepatic and renal function.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

SufentanilMorphine

Intervention Hierarchy (Ancestors)

FentanylPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsMorphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Officials

  • zhou yan, MD

    PKU 1st hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D

Study Record Dates

First Submitted

June 14, 2013

First Posted

August 6, 2013

Study Start

January 1, 2012

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

August 6, 2013

Record last verified: 2013-08