NCT02601508

Brief Summary

This study is designed to evaluate the surgeon's satisfaction with either deep or moderate neuromuscular blockade during laparoscopic gastrectomy surgery and observe the recovery profiles in the recovery room and the ward.The explorative objective of this study is to evaluate the safety profiles of deep and moderate neuromuscular blockades via observation of postoperative complications.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

November 3, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 10, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

November 10, 2015

Status Verified

November 1, 2015

Enrollment Period

9 months

First QC Date

November 3, 2015

Last Update Submit

November 8, 2015

Conditions

Neuromuscular Blockade

Keywords

deep NM blockSurgeon's satisfactionbridion

Outcome Measures

Primary Outcomes (1)

  • Surgical rating SCORE(SRS)

    excellent (5), good but not optimal (4), moderate (3), poor but acceptable (2) or poor and unacceptable (1)

    every 15 minutes from the pneumoperitoneum, up to 120 minutes till the end of surgery

Secondary Outcomes (6)

  • Respiratory rate

    every 15 minutes from the arrival on the recovery room, up to 60 minutes

  • peripheral arterial oxygen saturation

    every 15 minutes from the arrival on the recovery room, up to 60 minutes

  • visual analogue scale (VAS) for pain

    every 15 minutes from the arrival on the recovery room, up to 60 minutes

  • occurrence of nausea or vomiting

    every 15 minutes from the arrival on the recovery room, up to 60 minutes

  • the level of sedation or alertness

    every 15 minutes from the arrival on the recovery room, up to 60 minutes

  • +1 more secondary outcomes

Study Arms (2)

Modarate Blockade Group

ACTIVE COMPARATOR

Neuromuscular blocking agent, cis-atracurium will be administered after skin incision and reversal agents, pyridostigmine \& glycopyrrolate will be given for the recovery.

Drug: cis-atracurium

Deep Blockade Group

EXPERIMENTAL

Neuromuscular blocking agent, rocuronium will be administered after skin incision and reversal agent, Sugammadex will be given for the recovery.

Drug: Rocuronium

Interventions

RocuroniumDRUG

Continuous infusion of rocuronium for PTC 1 + Sugammadex

Also known as: Esmeron®
Deep Blockade Group
cis-atracuriumDRUG

Intermittent injection of cis-atracurium for TOF 1 + Pyridostigmine \& Glycopyrrolate

Also known as: Nimbex®
Modarate Blockade Group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All adult (≥ 20 years of age) patients scheduled for an elective laparoscopic gastrectomy who have signed the written informed consent.

You may not qualify if:

  • Known allergy to rocuronuim, cisatracurium or sugammadex
  • Significant liver or kidney dysfunction
  • Any neuromuscular disease
  • Pregnant or breast feeding
  • Indication for rapid sequence induction
  • Inability to give informed consent
  • Patients taking any medication with potential interference with neuromuscular transmission

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chonnam University Hwasun Hospital

Hwasun, 519-763, South Korea

Location

MeSH Terms

Interventions

Rocuroniumcisatracurium

Intervention Hierarchy (Ancestors)

AndrostanolsAndrostanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • SEONGWOOK JEONG, MD, PhD.

    Chonnam University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

SEONGHEON LEE, MD, PhD

CONTACT

+82-10-8612-9548headheadhead@naver.com

Shiyoung JEONG, MD

CONTACT

+82-10-9440-8415

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

November 3, 2015

First Posted

November 10, 2015

Study Start

November 1, 2015

Primary Completion

August 1, 2016

Study Completion

August 1, 2017

Last Updated

November 10, 2015

Record last verified: 2015-11

Locations

KR(1)