Effect of Higher Doses of Remifentanil on Postoperative Pain in Patients Undergoing Thyroidectomy

The recruitment status of this study is unknown because the information has not been verified recently.

Verified January 2013 by Central South University.
Recruitment status was Recruiting

Sponsor:

Information provided by (Responsible Party):

Ru-Ping Dai, Central South University

ClinicalTrials.gov Identifier:

NCT01761149

First received: December 30, 2012

Last updated: January 3, 2013

Last verified: January 2013

History of Changes

Purpose

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.

Condition	Intervention	Phase
Nodular Goiter	Drug: Remifentanil	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Comparison of Different Doses of Remifentanil on Postoperative Pain in Patients Undergoing Thyroidectomy: a Prospective, Double-blinded Randomized Control Trial

Resource links provided by NLM:

Drug Information available for: Remifentanil hydrochloride

U.S. FDA Resources

Further study details as provided by Central South University:

Primary Outcome Measures:

Changes of sensory threshold from baseline to postoperative 24hours [ Time Frame: 24 hour ] [ Designated as safety issue: Yes ]
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) [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
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.

Other Outcome Measures:

consumption of morphine postoperatively [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]


Estimated Enrollment:	60
Study Start Date:	December 2012
Estimated Primary Completion Date:	March 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Remifentanil (Low dose) remifentanil(Low):dose of 0.2ug/kg/min. The dose of remifentanil is widely used intraoperatively clinically;	Drug: Remifentanil The present study examine two different dose of remifentanil: low dose (0.2ug/kg/min) and high dose (1.2ug/kg/min)
Experimental: Remifentanil (High dose) The high dose of remifentanil is 1.2ug/kg/min. The does is sometimes used in clinical practice.	Drug: Remifentanil The present study examine two different dose of remifentanil: low dose (0.2ug/kg/min) and high dose (1.2ug/kg/min)

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.

Eligibility


Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01761149

Contacts


Contact: Ru-Ping Dai, MD, PhD	86-731-8529 ext 5970	Ruping_dai@yahoo.com.cn

Locations


China, Hunan
Department of Anesthesiology, The Second Xiangya Hospital	Recruiting
Changsha, Hunan, China, 410011
Contact: Yan-Ling Zhang, MD 86-731-8529 ext 5970 zhangyanling0618@yahoo.cn

Sponsors and Collaborators

Central South University

Investigators


Principal Investigator:	Ru-Ping Dai, MD	Central South University

More Information

No publications provided by Central South University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


Responsible Party:	Ru-Ping Dai, Associate Professor, MD, PhD, Central South University
ClinicalTrials.gov Identifier:	NCT01761149 History of Changes
Other Study ID Numbers:	XYEYYCT2013001
Study First Received:	December 30, 2012
Last Updated:	January 3, 2013
Health Authority:	China: Ethics Committee

Keywords provided by Central South University:


remifentanil, opioid, hyperalgesia, visual analogue score thyroidectomy,

Additional relevant MeSH terms:


Remifentanil Analgesics Analgesics, Opioid Anesthetics Anesthetics, General Anesthetics, Intravenous Central Nervous System Agents Central Nervous System Depressants	Hypnotics and Sedatives Narcotics Peripheral Nervous System Agents Pharmacologic Actions Physiological Effects of Drugs Sensory System Agents Therapeutic Uses

ClinicalTrials.gov processed this record on February 27, 2015

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