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Postoperative Analgesic Effect of Nefopam

NCT ID: NCT02561494

Last Updated: 2016-10-28

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2016-08-31

Brief Summary

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Nefopam will be administered to the patients undergoing laparoscopic gastrectomy under the total intravenous anesthesia (TIVA).

The investigators will evaluate whether the nefopam can decrease the total amount of remifentanil administered during the operation, which will reduce the acute opioid tolerance and following consumption of fentanyl during postoperative period.

Detailed Description

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Conditions

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Stomach Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Control

Intravenous normal saline 2 ml is given slowly as a placebo before the anesthesia induction and after finishing anesthesia.

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type DRUG

Nefopam

Intravenous nefopam 20 mg is given slowly before the anesthesia induction and after finishing anesthesia.

Group Type EXPERIMENTAL

Nefopam

Intervention Type DRUG

Interventions

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Nefopam

Intervention Type DRUG

Saline

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Early or advanced gastric cancer

Exclusion Criteria

* Refusal
* Use of preoperative analgesic drugs
* Pregnancy
* Recurred gastric cancer
* Seizure
* Cardiac disease
* Monoamine oxidase inhibitor
* Urologic disease
* Previous intrabdominal surgery
* Body mass index \> 30 or \< 16
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Bundang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hyo-Seok Na

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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Nefo_stomach op

Identifier Type: -

Identifier Source: org_study_id