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.

Study Overview

• Status: Unknown
• Conditions: Nodular Goiter
• Intervention / Treatment: Drug: Remifentanil

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Ru-Ping Dai, MD, PhD; Phone Number: 5970 86-731-8529; Email: Ruping_dai@yahoo.com.cn

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Time Frame
consumption of morphine postoperatively	24 hours

Collaborators and Investigators

• Sponsor: Central South University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Anticipated): March 1, 2013

Study Registration Dates

• First Submitted: December 30, 2012
• First Submitted That Met QC Criteria: January 3, 2013
• First Posted (Estimate): January 4, 2013

Study Record Updates

• Last Update Posted (Estimate): January 4, 2013
• Last Update Submitted That Met QC Criteria: January 3, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: opioid,; remifentanil,; hyperalgesia,; visual analogue score; thyroidectomy,
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Endocrine System Diseases; Thyroid Diseases; Goiter; Pain, Postoperative; Goiter, Nodular; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Remifentanil
• Other Study ID Numbers: XYEYYCT2013001