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Clinical Trials/NCT01732666
NCT01732666
Completed
Not Applicable

Effect of Nefopam on Remifentanil Induced Postoperative Hyperalgesia

Yonsei University1 site in 1 country25 target enrollmentMay 2012

Overview

Phase
Not Applicable
Intervention
low dose remifentanil
Conditions
Patients Undergoing Laparoscopic Gastrectomy
Sponsor
Yonsei University
Enrollment
25
Locations
1
Primary Endpoint
Hyperalgesic extent around surgical incision
Status
Completed
Last Updated
12 years ago

Overview

Brief Summary

Opioids has been reported to cause hyperalgesia. Opioid induced hyperalgesia (OIH) is defined as paradoxically lowering the threshold of pain after the exposure of opioid. Remifentanil is a short acting opioid that is commonly used during anesthesia and surgery. However, OIH was reported to occur after surgery when large amount of remifentanil was administered. On the other hand, nefopam is a centrally acting, non-opioid analgesic. Nefopam has been reported to have analgesic and anti-hyperalgesic effect.

The investigators hypothesized that nefopam administration could prevent OIH or reduce the severity of OIH. Therefore, the objective of the study is to find out the effect of nefopam on remifentanil induced hyperalgesia in patients undergoing laparoscopic abdominal surgery.

Registry
clinicaltrials.gov
Start Date
May 2012
End Date
September 2012
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients undergoing laparoscopic gastrectomy
  • American Society of Anesthesiologists physical status I or II
  • aged from 20 to 65 years

Exclusion Criteria

  • Past history of chronic pain
  • Drug or alcohol abuse
  • Psychotic disorder
  • Taking analgesics, anti-epileptics, and anti-depressants.
  • Taking opioids within 24 hrs
  • Renal disease
  • Neuromuscular disease.
  • Moderate to severe cardiovascular disease
  • Pregnant or breast-feeding

Arms & Interventions

group L

receives 100 ml of 0.9% saline immediately after anesthesia induction and 0.05µg/kg/min of remifentanil during anesthesia.

Intervention: low dose remifentanil

group H

100 ml of 0.9% saline immediately after anesthesia induction and 0.3 µg/kg/min of remifentanil during anesthesia.

Intervention: high dose remifentanil

group N

20mg of nefopam mixed in 100 ml of 0.9% saline immediately after anesthesia induction and 0.3 µg/kg/min of remifentanil during anesthesia.

Intervention: Nefopam

Outcomes

Primary Outcomes

Hyperalgesic extent around surgical incision

Time Frame: Postoperative 24 hr and 48 hr

The distance from the surgical incision to a point where patient does not feel pain when he gets stimuli with von Frey filament No.16 (122g/mm2).

Study Sites (1)

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