NCT03890406

Brief Summary

Recently, deep neuromuscular blockade during general anesthesia has been studied by many authors regarding various effects upon patients' outcomes and surgical conditions. We believe deep neuromuscular blockade can be especially beneficial in laparoscopic surgery, because it can expand surgical space and prevent patients' minute movements that can disturb precise operations. In clinical situations, anesthetists tend to compensate the insufficiency of neuromuscular blockade by increasing the dose of other anesthetic agents, which can prolong patients' recovery time and impair the surgical condition. In this study, we plan to divide the patients into 2 groups according to the depth of neuromuscular blockade, and compare the dose of anesthetic agent used to maintain surgical condition.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2019

Geographic Reach
1 country

1 active site

Status
completed

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

March 25, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 26, 2019

Completed
6 days until next milestone

Study Start

First participant enrolled

April 1, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2020

Completed
Last Updated

June 30, 2020

Status Verified

June 1, 2020

Enrollment Period

9 months

First QC Date

March 25, 2019

Last Update Submit

June 26, 2020

Conditions

LaparoscopyGeneral AnesthesiaNeuromuscular Blockade

Keywords

Deep neuromuscular blockade

Outcome Measures

Primary Outcomes (1)

  • Dosage of propofol

    the amount of propofol used (mg/kg)

    intraoperative (from starting of anesthesia to end of anesthesia)

Secondary Outcomes (4)

  • Dosage of remifentanil

    intraoperative (from starting of anesthesia to end of anesthesia)

  • Patient movement

    intraoperative (from tracheal intubation to injection of neuromuscular reversal agent)

  • Patient self respiration

    intraoperative (from tracheal intubation to injection of neuromuscular reversal agent)

  • Surgical condition score

    assessed at the end of the surgery

Study Arms (2)

Group D

EXPERIMENTAL

Deep neuromuscular blockade

Drug: Rocuronium: PTC(Post-tetanic count) 1~2

Group M

ACTIVE COMPARATOR

Moderate neuromuscular blockade

Drug: Rocuronium: TOF(Train-of-four) 1~2

Interventions

Rocuronium: PTC(Post-tetanic count) 1~2DRUG

Deep neuromuscular blockade will be maintained using continuous infusion of rocuronium.

Also known as: Deep block
Group D
Rocuronium: TOF(Train-of-four) 1~2DRUG

Moderate neuromuscular blockade will be maintained using continuous infusion of rocuronium.

Also known as: Moderate block
Group M

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing elective laparoscopic colorectal resection due to benign or malignant neoplasm of colon or rectum
  • ASA class I or II

You may not qualify if:

  • Patients receiving medications known to have drug-drug interaction with neuromuscular blocking agents
  • Patients who have significantly impaired cardiac, pulmonary, hepatic, renal function
  • Patients who are pregnant
  • Patients who are known to have hypersensitivity to the anesthetic/analgesic/neuromuscular blocking agents which are going to be used in the study
  • BMI \< 18.5 or \> 35.0 kg/m2
  • Patients with previous history of open abdominal surgery
  • Patients with previous history of malignant hyperthermia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

Location

Related Publications (1)

  • Nam SW, Oh AY, Koo BW, Kim BY, Han J, Chung SH. Effects of depth of neuromuscular blockade on the BIS-guided propofol requirement: A randomized controlled trial. Medicine (Baltimore). 2021 Jul 23;100(29):e26576. doi: 10.1097/MD.0000000000026576.

    PMID: 34398011DERIVED

Study Officials

  • Ah Young Oh, MD, PhD

    Seoul National University Bundang Hospital

    STUDY CHAIR

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
Assistant professor

Study Record Dates

First Submitted

March 25, 2019

First Posted

March 26, 2019

Study Start

April 1, 2019

Primary Completion

December 31, 2019

Study Completion

March 31, 2020

Last Updated

June 30, 2020

Record last verified: 2020-06

Locations

KR(1)