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Deep vs Moderate Neuromuscular Blocks on Remifentanil for Laparoscopic Gastrectomy

NCT ID: NCT04205097

Last Updated: 2020-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-23

Study Completion Date

2020-12-02

Brief Summary

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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.

Detailed Description

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Conditions

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Gastric Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Moderate NMB group

maintaining of moderate neuromuscular block (train-of-four count 1-2) during surgery, reversal using neostigmine 50 ug/kg and glycopyrrolate 10 ug/kg

Group Type PLACEBO_COMPARATOR

Neostigmine + glycopyrate

Intervention Type DRUG

maintaining 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

maintaining of deep neuromuscular block (posttetanic count 1-2) during surgery, reversal using sugammadex 2\~4 mg/kg

Group Type EXPERIMENTAL

Sugammadex

Intervention Type DRUG

maintaining of deep neuromuscular block (posttetanic count 1-2) during surgery, reversal using sugammadex 2-4 mg/kg

Interventions

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Neostigmine + glycopyrate

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

Sugammadex

maintaining of deep neuromuscular block (posttetanic count 1-2) during surgery, reversal using sugammadex 2-4 mg/kg

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ajou University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Ji Eun Kim

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Suwon, Gyeonggido, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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AJIRB-MED-THE-19-217

Identifier Type: -

Identifier Source: org_study_id