Postoperative Analgesic Effect of Nefopam
1 other identifier
interventional
78
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2015
CompletedFirst Submitted
Initial submission to the registry
August 2, 2015
CompletedFirst Posted
Study publicly available on registry
September 28, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedOctober 28, 2016
October 1, 2016
1.2 years
August 2, 2015
October 27, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Change of the administered fentanyl dose from postoperative 6 h to postoperative 5 day
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
postoperative 6 h, postoperative 1 day, postoperative 2 day, postoperative 3 day, postoperative 5 day
Study Arms (2)
Control
PLACEBO COMPARATORIntravenous normal saline 2 ml is given slowly as a placebo before the anesthesia induction and after finishing anesthesia.
Nefopam
EXPERIMENTALIntravenous nefopam 20 mg is given slowly before the anesthesia induction and after finishing anesthesia.
Interventions
Eligibility Criteria
You may qualify if:
- Early or advanced gastric cancer
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 443-607, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctor
Study Record Dates
First Submitted
August 2, 2015
First Posted
September 28, 2015
Study Start
June 1, 2015
Primary Completion
August 1, 2016
Study Completion
August 1, 2016
Last Updated
October 28, 2016
Record last verified: 2016-10