Comparison of the Effect of Intravenous and Perineural Dexmedetomidine in Gastric Cancer Surgery
1 other identifier
interventional
90
1 country
1
Brief Summary
Using random case assignment to investigate the analgesic and sedative effect of intravenous dexmedetomidine and dexmedetomidine as a local anesthetic adjuvant in ultrasound-guided subcostal TAP block in gastric cancer patient undergoing gastrectomy or partial gastrectomy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable gastric-cancer
Started Dec 2017
Typical duration for not_applicable gastric-cancer
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
December 23, 2017
CompletedFirst Submitted
Initial submission to the registry
December 27, 2017
CompletedFirst Posted
Study publicly available on registry
January 8, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedJanuary 12, 2018
January 1, 2018
3 years
December 27, 2017
January 10, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
analgesic effect - pain intensity
postoperative acute pain intensity (numerical rating scale, NRS, 0-10)
postoperative 3 days
Secondary Outcomes (2)
sedative effect
postoperative 2 hours
analgesic effect - opioid consumption
postoperative 3 days
Study Arms (3)
Dexmedetomidine_iv group
EXPERIMENTALDexmedetomidine 0.5mcg/kg (diluted in normal saline) intravenously infusion for 30min
Dexmedetomidine_adj group
EXPERIMENTALDexmedetomidine 0.5mcg/kg (adding to local anesthetic) perineural single bolus for subcostal TAP block 0.9% sodium chloride 0.125ml/kg intravenously infusion for 30min
Control group
ACTIVE COMPARATOR0.9% sodium chloride 0.125ml/kg intravenously infusion for 30min No dexmedetomidine use
Interventions
0.5mcg/kg intravenous(IV)continuous infusion for 30 minutes, or 0.5mcg/kg adding to local anesthetic for subcostal TAP block
0.125ml/kg intravenously infusion in Dexmedetomidine\_adj group and control group
Eligibility Criteria
You may qualify if:
- gastric cancer patients undergoing gastrectomy or partial gastrectomy, who receive ultrasound-guided subcostal TAP block and PCA for postoperative analgesia
You may not qualify if:
- surgery involved other visceral organ (eg. combined splenectomy or partial hepatectomy), patients with histories of adverse drug reaction to dexmedetomidine, bradycardia (baseline heart rate \<60 beats/min), any type of atrioventricular block in electrocardiogram (EKG), heart failure, significant renal or hepatic impairment, severe bronchopulmonary disease, any coagulant disorder, and pregnant or breast-feeding woman.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kaohsiung Medical University Hospital
Kaohsiung City, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Miao-Pei Su, M.D.
Physician
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Physician
Study Record Dates
First Submitted
December 27, 2017
First Posted
January 8, 2018
Study Start
December 23, 2017
Primary Completion
December 31, 2020
Study Completion
December 31, 2020
Last Updated
January 12, 2018
Record last verified: 2018-01
Data Sharing
- IPD Sharing
- Will not share