Effect of Nefopam on Remifentanil Induced Postoperative Hyperalgesia

Yonsei University

Status: Completed

Conditions: Patients Undergoing Laparoscopic Gastrectomy

Treatments: Drug: low dose remifentanil; Drug: Nefopam; Drug: high dose remifentanil

Study type: Interventional

Funder types: Other

Identifiers

NCT01732666

4-2011-0883

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

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

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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25 participants in 3 patient groups, including a placebo group

group L

Placebo Comparator group

Description:

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

Treatment:

Drug: low dose remifentanil

group H

Placebo Comparator group

Description:

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

Treatment:

Drug: high dose remifentanil

group N

Experimental group

Description:

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.

Treatment:

Drug: Nefopam