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CompletedNCT01732666Updated Feb 19, 2014

Effect of Nefopam on Remifentanil Induced Postoperative Hyperalgesia

An interventional study of Nefopam and low dose remifentanil in Patients Undergoing Laparoscopic Gastrectomy, sponsored by Yonsei University. Completed at 1 site in Korea, Republic of. Open to participants aged 20 Years to 65 Years. Per ClinicalTrials.gov, last updated 2014-02-19.

Sponsored by Yonsei University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Randomized
Ages
20 Years to 65 Years
Sex
All
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Study 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.

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Conditions studied

  • Patients Undergoing Laparoscopic Gastrectomy

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Keywords

  • Opioid-induced hyperalgesia (OIH)
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In context

Hyperalgesia

152 studies on the registry are indexed under Hyperalgesia; 13 are open to participants now.

This study's enrollment of 25 is below the median of 42 across 127 interventional studies indexed under Hyperalgesia.

Browse Hyperalgesia studies →

Lead sponsor

Yonsei University is the lead sponsor of 1,387 studies on the registry; 232 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Patients undergoing laparoscopic gastrectomy
  2. American Society of Anesthesiologists physical status I or II
  3. aged from 20 to 65 years

Exclusion criteria

Exclusion Criteria:

  1. Past history of chronic pain
  2. Drug or alcohol abuse
  3. Psychotic disorder
  4. Taking analgesics, anti-epileptics, and anti-depressants.
  5. Taking opioids within 24 hrs
  6. Renal disease
  7. Neuromuscular disease.
  8. Moderate to severe cardiovascular disease
  9. Pregnant or breast-feeding
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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
25 participants (actual)

Study arms

  • Placebo comparator
    group L

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

    Drug: low dose remifentanil

  • Placebo comparator
    group H

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

    Drug: high dose remifentanil

  • Experimental
    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.

    Drug: Nefopam

Interventions

  • DrugNefopam

    20 mg of Nefopam mixed in 100 ml of 0.9% saline IV immediately after induction of anesthesia.

  • Druglow dose remifentanil

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

  • Drughigh dose remifentanil

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

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What researchers measure

Primary outcomes

  1. Hyperalgesic extent around surgical incision

    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).

    Time frame: Postoperative 24 hr and 48 hr

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Study locations

1 site
  • Severance hospital
    Seoul, 120-752, Korea, Republic of
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 19, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01732666
Lead sponsor
Yonsei University
Responsible party
Sponsor
First posted
Nov 26, 2012
Start date
May 2012
Primary completion
Sep 2012
Completion
Sep 2012
Last update
Feb 19, 2014

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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