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OpenTrials
Completed

NCT Number: NCT02561494

Postoperative Analgesic Effect of Nefopam

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.

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Key information

Conditions

Stomach Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 443-607, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nefopam

Drug

Saline

Drug

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Sep 28, 2015
Registry last updated
Oct 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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