Postoperative Analgesic Effect of Nefopam

October 27, 2016 updated by: Hyo-Seok Na, Seoul National University Bundang Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

78

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeonggi
      • Seongnam, Gyeonggi, Korea, Republic of, 443-607
        • Seoul National University Bundang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Control
Intravenous normal saline 2 ml is given slowly as a placebo before the anesthesia induction and after finishing anesthesia.
Drug: Saline
EXPERIMENTAL: Nefopam
Intravenous nefopam 20 mg is given slowly before the anesthesia induction and after finishing anesthesia.
Drug: Nefopam

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change of the administered fentanyl dose from postoperative 6 h to postoperative 5 day
Time Frame: postoperative 6 h, postoperative 1 day, postoperative 2 day, postoperative 3 day, postoperative 5 day
postoperative 6 h, postoperative 1 day, postoperative 2 day, postoperative 3 day, postoperative 5 day

Secondary Outcome Measures

Outcome Measure
Time Frame
Change of the pain score from postoperative 6 h to postoperative 5 day
Time Frame: postoperative 6 h, postoperative 1 day, postoperative 2 day, postoperative 3 day, postoperative 5 day
postoperative 6 h, postoperative 1 day, postoperative 2 day, postoperative 3 day, postoperative 5 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Bundang Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (ACTUAL)

August 1, 2016

Study Completion (ACTUAL)

August 1, 2016

Study Registration Dates

First Submitted

August 2, 2015

First Submitted That Met QC Criteria

September 24, 2015

First Posted (ESTIMATE)

September 28, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

October 28, 2016

Last Update Submitted That Met QC Criteria

October 27, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Nefo_stomach op

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stomach Neoplasms

Clinical Trials on Saline

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Vietnam

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe