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Deep vs Moderate Neuromuscular Blocks on Remifentanil for Laparoscopic Gastrectomy

Primary Purpose

Gastric Cancer

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Neostigmine + glycopyrate
Sugammadex
Sponsored by
Ajou University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Gastric Cancer

Eligibility Criteria

19 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Clinical diagnosis of gastric cancer Scheduled laparoscopic gastrectomy

Exclusion Criteria:

  • Patients refusal to consent Hyperbilirubinemia Chronic pain Opioid abuse Incurrent infective status Peripheral vascular disease

Sites / Locations

  • Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Moderate NMB group

Deep NMB group

Arm Description

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

Outcomes

Primary Outcome Measures

total dose of remifentanil
remifentanil infusion using target effect-site concentration to achieve an surgical pleth index of range between 20 and 50

Secondary Outcome Measures

Full Information

First Posted
December 16, 2019
Last Updated
December 15, 2020
Sponsor
Ajou University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT04205097
Brief Title
Deep vs Moderate Neuromuscular Blocks on Remifentanil for Laparoscopic Gastrectomy
Official Title
Deep Versus Moderate Neuromuscular Blocks on Remifentanil Requirements in Patients Undergoing Surgical Pleth Index-guided Analgesia for Laparoscopic Gastrectomy
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
December 23, 2019 (Actual)
Primary Completion Date
December 2, 2020 (Actual)
Study Completion Date
December 2, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ajou University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Moderate NMB group
Arm Type
Placebo Comparator
Arm Description
maintaining of moderate neuromuscular block (train-of-four count 1-2) during surgery, reversal using neostigmine 50 ug/kg and glycopyrrolate 10 ug/kg
Arm Title
Deep NMB group
Arm Type
Experimental
Arm Description
maintaining of deep neuromuscular block (posttetanic count 1-2) during surgery, reversal using sugammadex 2~4 mg/kg
Intervention Type
Drug
Intervention Name(s)
Neostigmine + glycopyrate
Intervention Description
maintaining of moderate neuromuscular block (train-of-four count 1-2) during surgery, reversal using neostigmine 50 ug/kg and glycopyrrolate 10 ug/kg
Intervention Type
Drug
Intervention Name(s)
Sugammadex
Intervention Description
maintaining of deep neuromuscular block (posttetanic count 1-2) during surgery, reversal using sugammadex 2-4 mg/kg
Primary Outcome Measure Information:
Title
total dose of remifentanil
Description
remifentanil infusion using target effect-site concentration to achieve an surgical pleth index of range between 20 and 50
Time Frame
from pneumoperitoneum to removal of laparoscope

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of gastric cancer Scheduled laparoscopic gastrectomy Exclusion Criteria: Patients refusal to consent Hyperbilirubinemia Chronic pain Opioid abuse Incurrent infective status Peripheral vascular disease
Facility Information:
Facility Name
Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine
City
Suwon
State/Province
Gyeonggido
ZIP/Postal Code
16499
Country
Korea, Republic of

12. IPD Sharing Statement

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Deep vs Moderate Neuromuscular Blocks on Remifentanil for Laparoscopic Gastrectomy

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