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

Nodular Goiter Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01761149
• Other study ID #: XYEYYCT2013001
• Status: Recruiting
• Phase: Phase 4
• First received: December 30, 2012
• Last updated: January 3, 2013
• Start date: December 2012

Study information

• Verified date: January 2013
• Source: Central South University
• Contact: Ru-Ping Dai, MD, PhD
• Phone: 86-731-8529
• Email: Ruping_dai[@]yahoo.com.cn
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Goiter, Nodular
• Nodular Goiter
• Pain, Postoperative

Intervention

Drug:
• Remifentanil
The present study examine two different dose of remifentanil: low dose (0.2ug/kg/min) and high dose (1.2ug/kg/min)

Locations

Country	Name	City	State
China	Department of Anesthesiology, The Second Xiangya Hospital	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Central South University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	consumption of morphine postoperatively		24 hours	Yes
Primary	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	24 hour	Yes
Secondary	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.	24 hours	Yes