Effect of Nefopam on Remifentanil Induced Postoperative Hyperalgesia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2012-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Postoperative Analgesic Effect of Nefopam

NCT02561494

Stomach Neoplasms

COMPLETED NA

Effect of Intraoperative Nefopam on Acute Pain After Remifentanil Based Anesthesia

NCT02493231

Cholecystitis

UNKNOWN PHASE4

Nefopam/Fentanyl Postoperative Intravenous Patient-Controlled-Analgesia

NCT02596269

Laparotomy

COMPLETED PHASE2/PHASE3

Effects of Nefopam on Hyperalgesia After Cardiac Surgery

NCT00413257

Hyperalgesia Pain, Postoperative Pain, Chronic Disease

COMPLETED PHASE2/PHASE3

Effect of Nefopam on Acute Postoperative Pain in Patients Undergoing Orthognathic Surgery

NCT01461031

Pain Orthognathic Surgery

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Patients Undergoing Laparoscopic Gastrectomy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

group L

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

Group Type PLACEBO_COMPARATOR

low dose remifentanil

Intervention Type DRUG

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

group H

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

Group Type PLACEBO_COMPARATOR

high dose remifentanil

Intervention Type DRUG

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

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.

Group Type EXPERIMENTAL

Nefopam

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Nefopam

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

Intervention Type DRUG

low dose remifentanil

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

Intervention Type DRUG

high dose remifentanil

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No