Effect of Propofol on Remifentanil-induced Postoperative Hyperalgesia in Patients Undergoing Thyroid Surgery

NCT ID: NCT01189721

Last Updated: 2010-08-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2011-07-31

Brief Summary

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The investigators hypothesize that propofol infusion during surgery can affect the remifentanil hyperalgesia compared to sevoflurane inhalation.The outcome will be measured by a verbal numerical rating score (VNRS) and mechanical punctuating pain by electronic von frey filament.

Detailed Description

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Conditions

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Hyperalgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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sevoflurane

Remifentanil will be infused intraoperatively at 0.2 ㎍/㎏/min. patients who are in this group will be infused propofol intraoperatively.

Group Type ACTIVE_COMPARATOR

propofol, sevoflurane

Intervention Type DRUG

Remifentanil will be infused intraoperatively at 0.2 ㎍/㎏/min (group1 and 2) group 1 (Active Comparator, sevoflurane)will be infused propofol intraoperatively.

group 2(Experimental, propofol) will be inhaled sevoflurane intraoperatively.

propofol

Remifentanil will be infused intraoperatively at 0.2 ㎍/㎏/min. patients included this group will be inhaled sevoflurane intraoperatively.

Group Type EXPERIMENTAL

propofol, sevoflurane

Intervention Type DRUG

Remifentanil will be infused intraoperatively at 0.2 ㎍/㎏/min (group1 and 2) group 1 (Active Comparator, sevoflurane)will be infused propofol intraoperatively.

group 2(Experimental, propofol) will be inhaled sevoflurane intraoperatively.

Interventions

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propofol, sevoflurane

Remifentanil will be infused intraoperatively at 0.2 ㎍/㎏/min (group1 and 2) group 1 (Active Comparator, sevoflurane)will be infused propofol intraoperatively.

group 2(Experimental, propofol) will be inhaled sevoflurane intraoperatively.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients undergoing thyroidectomy
* Age 20-65
* American Society of Anesthesiologists physical status classification I or II

Exclusion Criteria

* History of chronic pain, Regular use of analgesic, antiepileptic or antidepressive drugs
* History of drug \& alcohol abuse
* Psychiatric disorder
* Use of opioids within 24hrs
* Renal disease with decreased glomerular filtrate ratio
* Neuromuscular disease, Severe cardiac disease
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gangnam Severance Hospital

OTHER

Sponsor Role lead

Responsible Party

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Anesthesia and Pain Research Institute

Principal Investigators

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yuen hee shim, MD

Role: STUDY_CHAIR

Gangnam severance hospital, Yonsei university, Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Reseach Institute

Locations

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Gang Nam Severance Hospital, Yonsei University, Anesthesia and Pain Medicine Department,

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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young ju won, MD.

Role: CONTACT

082-2-2019-6805

yuen hee shim, MD.

Role: CONTACT

082-2-2019-6808

Facility Contacts

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young ju won, MD

Role: primary

082-2-2019-6805

Other Identifiers

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3-2010-0102

Identifier Type: -

Identifier Source: org_study_id

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