NCT01761149

Brief Summary

Extensive clinical studies have shown that intraoperative infusion high dose of remifentanil (0.2ug/kg/min) induced postoperative hyperalgesia. Recent experimental study however suggests that higher dose of remifentanil may attenuate postoperative hyperalgesia. Thus, the present study is designed as a "proof of principle" study and hypothesizes that higher dose of remifentanil may reduce postoperative pain in patients.

Trial Health

55
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Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

December 30, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 4, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Last Updated

January 4, 2013

Status Verified

January 1, 2013

Enrollment Period

3 months

First QC Date

December 30, 2012

Last Update Submit

January 3, 2013

Conditions

Nodular Goiter

Keywords

remifentanil,opioid,hyperalgesia,visual analogue scorethyroidectomy,

Outcome Measures

Primary Outcomes (1)

  • Changes of sensory threshold from baseline to postoperative 24hours

    Quantitative sensory threshold in the remote uninjured site (here, the inner forearm) is commonly used to examine the occurrence of postoperative hyperalgesia. The present study will examine the mechanical threshold in two different doses of remifentanil to determine whether high dose of remifentanil induces hyperalgesia

    24 hour

Secondary Outcomes (1)

  • visual analogue score (VAS)

    24 hours

Other Outcomes (1)

  • consumption of morphine postoperatively

    24 hours

Study Arms (2)

Remifentanil (Low dose)

ACTIVE COMPARATOR

remifentanil(Low):dose of 0.2ug/kg/min. The dose of remifentanil is widely used intraoperatively clinically;

Drug: Remifentanil

Remifentanil (High dose)

EXPERIMENTAL

The high dose of remifentanil is 1.2ug/kg/min. The does is sometimes used in clinical practice.

Drug: Remifentanil

Interventions

RemifentanilDRUG

The present study examine two different dose of remifentanil: low dose (0.2ug/kg/min) and high dose (1.2ug/kg/min)

Remifentanil (High dose)Remifentanil (Low dose)

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • ASA Grade I or II
  • Age 18-60 years old
  • BMI\<35,

You may not qualify if:

  • do not consent,
  • Chronic pain,
  • used pain killer,
  • undergoing operation previously
  • diabetes or the other diseases affecting the sensory.
  • difficult intubation;
  • unexpected surgical complication such as bleeding;
  • psychiatric disorders;
  • drug or alchohol abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology, The Second Xiangya Hospital

Changsha, Hunan, 410011, China

RECRUITING

Related Publications (1)

  • Zhang YL, Ou P, Lu XH, Chen YP, Xu JM, Dai RP. Effect of intraoperative high-dose remifentanil on postoperative pain: a prospective, double blind, randomized clinical trial. PLoS One. 2014 Mar 25;9(3):e91454. doi: 10.1371/journal.pone.0091454. eCollection 2014.

    PMID: 24667391DERIVED

MeSH Terms

Conditions

Goiter, NodularHyperalgesia

Interventions

Remifentanil

Condition Hierarchy (Ancestors)

GoiterThyroid DiseasesEndocrine System DiseasesSomatosensory DisordersSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PropionatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Ru-Ping Dai, MD

    Second Xiangya Hospital of Central South University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ru-Ping Dai, MD, PhD

CONTACT

86-731-8529Ruping_dai@yahoo.com.cn

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, MD, PhD

Study Record Dates

First Submitted

December 30, 2012

First Posted

January 4, 2013

Study Start

December 1, 2012

Primary Completion

March 1, 2013

Last Updated

January 4, 2013

Record last verified: 2013-01

Locations

CN(1)