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

This study is currently recruiting participants.
Verified January 2013 by Central South University
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

December 30, 2012
January 3, 2013
December 2012
March 2013   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01761149 on ClinicalTrials.gov Archive Site
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.
Same as current
consumption of morphine postoperatively [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
Same as current
 
Effect of Higher Doses of Remifentanil on Postoperative Pain in Patients Undergoing Thyroidectomy
Comparison of Different Doses of Remifentanil on Postoperative Pain in Patients Undergoing Thyroidectomy: a Prospective, Double-blinded Randomized Control Trial

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Nodular Goiter
Drug: Remifentanil
The present study examine two different dose of remifentanil: low dose (0.2ug/kg/min) and high dose (1.2ug/kg/min)
  • Active Comparator: Remifentanil (Low dose)
    remifentanil(Low):dose of 0.2ug/kg/min. The dose of remifentanil is widely used intraoperatively clinically;
    Intervention: Drug: Remifentanil
  • Experimental: Remifentanil (High dose)
    The high dose of remifentanil is 1.2ug/kg/min. The does is sometimes used in clinical practice.
    Intervention: Drug: Remifentanil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
Not Provided
March 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact: Ru-Ping Dai, MD, PhD 86-731-8529 ext 5970 Ruping_dai@yahoo.com.cn
China
 
NCT01761149
XYEYYCT2013001
Yes
Ru-Ping Dai, Central South University
Central South University
Not Provided
Principal Investigator: Ru-Ping Dai, MD Central South University
Central South University
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP