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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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01761149
Enrollment
60
Registered
2013-01-04
Start date
2012-12-31
Completion date
Unknown
Last updated
2013-01-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nodular Goiter

Keywords

remifentanil,, opioid,, hyperalgesia,, visual analogue score, thyroidectomy,

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.

Interventions

DRUGRemifentanil

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

Sponsors

Central South University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Changes of sensory threshold from baseline to postoperative 24hours24 hourQuantitative 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

MeasureTime frameDescription
visual analogue score (VAS)24 hoursVAS 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

MeasureTime frame
consumption of morphine postoperatively24 hours

Countries

China

Contacts

Primary ContactRu-Ping Dai, MD, PhD
Ruping_dai@yahoo.com.cn86-731-8529

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026