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Clinical Trials/NCT01761149
NCT01761149
Unknown
Phase 4

Comparison of Different Doses of Remifentanil on Postoperative Pain in Patients Undergoing Thyroidectomy: a Prospective, Double-blinded Randomized Control Trial

Central South University1 site in 1 country60 target enrollmentDecember 2012
ConditionsNodular Goiter
InterventionsRemifentanil

Overview

Phase
Phase 4
Intervention
Remifentanil
Conditions
Nodular Goiter
Sponsor
Central South University
Enrollment
60
Locations
1
Primary Endpoint
Changes of sensory threshold from baseline to postoperative 24hours
Last Updated
13 years ago

Overview

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.

Detailed Description

Remifentanil, an ultra-short acting opioid, is widely used in the patients undergoing surgery. However, extensive studies report that remifentanil,administered at 0.2ug/kg/min or 0.4ug/kg/min intraoperatively, can result in postoperative hyperalgesia and increase the consumption of analgesics when compared with low dose (0.05ug/kg/min). However, a recent experimental study shows that large dose of remifentanil can inhibit pain hypersensitivity through erasing the spinal sensitization of pain. The present study thus hypothesizes that higher dose of remifentanil (1.2ug/kg/min) may attenuate postoperative pain. The present study will compare the effect of two different dose of remifentanil (0.2ug/kg/min and 1.2ug/kg/min) on postoperative pain. Patients undergoing thyroidectomy will be recruited, and mechanical threshold will be measured in the remote region of surgical site preoperatively. The patients will be randomly divided by two groups, 0.2ug/kg/min (group I) and 1.2ug/kg/min (group II). After operation, mechanical threshold and visual analogue scale (VAS) will be measured as the indicators of postoperative pain. The consumption of morphine will also be compared between these two doses of remifentanil. The present study may find optimized dose of opioid usage in the patients undergoing surgery to relieve the postoperative pain.

Registry
clinicaltrials.gov
Start Date
December 2012
End Date
March 2013
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Central South University
Responsible Party
Principal Investigator
Principal Investigator

Ru-Ping Dai

Associate Professor, MD, PhD

Central South University

Eligibility Criteria

Inclusion Criteria

  • ASA Grade I or II
  • Age 18-60 years old

Exclusion Criteria

  • 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

Arms & Interventions

Remifentanil (Low dose)

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

Intervention: Remifentanil

Remifentanil (High dose)

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

Intervention: Remifentanil

Outcomes

Primary Outcomes

Changes of sensory threshold from baseline to postoperative 24hours

Time Frame: 24 hour

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

Secondary Outcomes

  • visual analogue score (VAS)(24 hours)

Study Sites (1)

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