Deep vs Moderate Neuromuscular Blocks on Remifentanil for Laparoscopic Gastrectomy
Deep Versus Moderate Neuromuscular Blocks on Remifentanil Requirements in Patients Undergoing Surgical Pleth Index-guided Analgesia for Laparoscopic Gastrectomy
1 other identifier
interventional
120
1 country
1
Brief Summary
The primary purpose is to compare the remifentanil requirements in deep vs moderate neuromuscular blocks during the surgical pleth index -guided anesthesia in patients undergoing laparoscopic gastrectomy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable gastric-cancer
Started Dec 2019
Shorter than P25 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
First Submitted
Initial submission to the registry
December 16, 2019
CompletedFirst Posted
Study publicly available on registry
December 19, 2019
CompletedStudy Start
First participant enrolled
December 23, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 2, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 2, 2020
CompletedDecember 17, 2020
December 1, 2020
12 months
December 16, 2019
December 15, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
total dose of remifentanil
remifentanil infusion using target effect-site concentration to achieve an surgical pleth index of range between 20 and 50
from pneumoperitoneum to removal of laparoscope
Study Arms (2)
Moderate NMB group
PLACEBO COMPARATORmaintaining of moderate neuromuscular block (train-of-four count 1-2) during surgery, reversal using neostigmine 50 ug/kg and glycopyrrolate 10 ug/kg
Deep NMB group
EXPERIMENTALmaintaining of deep neuromuscular block (posttetanic count 1-2) during surgery, reversal using sugammadex 2\~4 mg/kg
Interventions
maintaining of moderate neuromuscular block (train-of-four count 1-2) during surgery, reversal using neostigmine 50 ug/kg and glycopyrrolate 10 ug/kg
maintaining of deep neuromuscular block (posttetanic count 1-2) during surgery, reversal using sugammadex 2-4 mg/kg
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of gastric cancer Scheduled laparoscopic gastrectomy
You may not qualify if:
- Patients refusal to consent Hyperbilirubinemia Chronic pain Opioid abuse Incurrent infective status Peripheral vascular disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine
Suwon, Gyeonggido, 16499, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant professor
Study Record Dates
First Submitted
December 16, 2019
First Posted
December 19, 2019
Study Start
December 23, 2019
Primary Completion
December 2, 2020
Study Completion
December 2, 2020
Last Updated
December 17, 2020
Record last verified: 2020-12