Effect of Higher Doses of Remifentanil on Postoperative Pain in Patients Undergoing Thyroidectomy
Primary Purpose
Nodular Goiter
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Remifentanil
Sponsored by
About this trial
This is an interventional treatment trial for Nodular Goiter focused on measuring remifentanil,, opioid,, hyperalgesia,, visual analogue score, thyroidectomy,
Eligibility Criteria
Inclusion Criteria:
- ASA Grade I or II
- Age 18-60 years old
- BMI<35,
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
Sites / Locations
- Department of Anesthesiology, The Second Xiangya HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Remifentanil (Low dose)
Remifentanil (High dose)
Arm Description
remifentanil(Low):dose of 0.2ug/kg/min. The dose of remifentanil is widely used intraoperatively clinically;
The high dose of remifentanil is 1.2ug/kg/min. The does is sometimes used in clinical practice.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
visual analogue score (VAS)
VAS is widely used to assess postoperative pain. It will be divided as 10 points. Zero refers to no pain and ten refers to extremely pain. Based on this way, we can know the difference of postoperative pain in these two different groups.
Full Information
NCT ID
NCT01761149
First Posted
December 30, 2012
Last Updated
January 3, 2013
Sponsor
Central South University
1. Study Identification
Unique Protocol Identification Number
NCT01761149
Brief Title
Effect of Higher Doses of Remifentanil on Postoperative Pain in Patients Undergoing Thyroidectomy
Official Title
Comparison of Different Doses of Remifentanil on Postoperative Pain in Patients Undergoing Thyroidectomy: a Prospective, Double-blinded Randomized Control Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Unknown status
Study Start Date
December 2012 (undefined)
Primary Completion Date
March 2013 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Central South University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nodular Goiter
Keywords
remifentanil,, opioid,, hyperalgesia,, visual analogue score, thyroidectomy,
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Remifentanil (Low dose)
Arm Type
Active Comparator
Arm Description
remifentanil(Low):dose of 0.2ug/kg/min. The dose of remifentanil is widely used intraoperatively clinically;
Arm Title
Remifentanil (High dose)
Arm Type
Experimental
Arm Description
The high dose of remifentanil is 1.2ug/kg/min. The does is sometimes used in clinical practice.
Intervention Type
Drug
Intervention Name(s)
Remifentanil
Intervention Description
The present study examine two different dose of remifentanil: low dose (0.2ug/kg/min) and high dose (1.2ug/kg/min)
Primary Outcome Measure Information:
Title
Changes of sensory threshold from baseline to postoperative 24hours
Description
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
Time Frame
24 hour
Secondary Outcome Measure Information:
Title
visual analogue score (VAS)
Description
VAS is widely used to assess postoperative pain. It will be divided as 10 points. Zero refers to no pain and ten refers to extremely pain. Based on this way, we can know the difference of postoperative pain in these two different groups.
Time Frame
24 hours
Other Pre-specified Outcome Measures:
Title
consumption of morphine postoperatively
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
ASA Grade I or II
Age 18-60 years old
BMI<35,
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ru-Ping Dai, MD, PhD
Phone
86-731-8529
Ext
5970
Email
Ruping_dai@yahoo.com.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ru-Ping Dai, MD
Organizational Affiliation
Central South University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Anesthesiology, The Second Xiangya Hospital
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410011
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yan-Ling Zhang, MD
Phone
86-731-8529
Ext
5970
Email
zhangyanling0618@yahoo.cn
12. IPD Sharing Statement
Citations:
PubMed Identifier
24667391
Citation
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.
Results Reference
derived
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Effect of Higher Doses of Remifentanil on Postoperative Pain in Patients Undergoing Thyroidectomy
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