The Effect of Deep Neuromuscular Blockade on Requirement... | NCT03890406

Studies
The Effect of Deep Neuromuscular Blockade on Requirement of Intravenous Anesthetic Agent

NCT03890406

Sponsor

Seoul National University Bundang Hospital

Status

Completed

Last Update Posted

Jun 30, 2020Actual

Enrollment

88Actual

Phase

Not Applicable

Conditions

Laparoscopy
General Anesthesia
Neuromuscular Blockade

Interventions

Rocuronium: PTC(Post-tetanic count) 1~2
Rocuronium: TOF(Train-of-four) 1~2

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2019Actual

Primary Completion Date

Dec 31, 2019Actual

Completion Date

Mar 31, 2020Actual

First Submitted Date

Mar 25, 2019

First Submission Date that Met QC Criteria

Mar 25, 2019

First Posted Date

Mar 26, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 26, 2020

Last Update Posted Date

Jun 30, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

BON WOOK KOO, Assistant professor, Seoul National University Bundang HospitalPrincipal Investigator

Lead Sponsor

Seoul National University Bundang HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Patients undergoing elective laparoscopic colorectal surgery are going to be recruited and divided into 2 groups: Group D will receive deep neuromuscular blockade, and Group M will receive moderate neuromuscular blockade using continuous infusion of rocuronium. Acceleromyography(TOF-watch SX) will be used to monitor the depth of blockade. In both groups, the anesthesia will be maintained with TIVA(total intra-venous anesthesia) including continuous target-controlled infusion of propofol and remifentanil. During the surgery, the number of patient movement and restoration of self respiration will be recorded. At the end of anesthesia, the dose of propofol and remifentanil used will be assessed and compared between the groups. Also, the satisfaction score of surgeons regarding the surgical condition, the anesthesia time, the operation time will be documented. After the patients are discharged, their charts are going to be reviewed and whether any pulmonary or surgical complications occurred will be documented.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

88Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Rocuronium: PTC(Post-tetanic count) 1~2	Drug	Deep neuromuscular blockade will be maintained using continuous infusion of rocuronium.	Group D

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Dosage of propofol	the amount of propofol used (mg/kg)	intraoperative (from starting of anesthesia to end of anesthesia)

Secondary Outcomes

Measure	Description	Time Frame
Dosage of remifentanil	the amount of remifentanil used (mcg/kg)	intraoperative (from starting of anesthesia to end of anesthesia)
Patient movement	the observed number of patient movement during the surgery

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ah Young Oh, MD, PhD	Seoul National University Bundang Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Bundang Hospital		Seongnam-si	Gyeonggi-do	13620	South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34398011	Derived	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.