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Monitoring of Postoperative Residual Neuromuscular Blockade in Laparoscopic Surgery

Primary Purpose

Neuromuscular Block, Residual

Status

Completed

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Neostigmine

Sugammadex

About this trial

This is an interventional supportive care trial for Neuromuscular Block, Residual

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

patients aged over 18 years, planned to undergoing elective laparoscopic surgery under general anesthesia

Exclusion Criteria:

Obesity BMI over 30 kg/m2
Impairment of renal or/and liver function
Allergy to rocuronium, sugammadex
(Familial) history of malignant hyperthermia
Taking medicines which is affecting neuromuscular function

Sites / Locations

Seoul National University Bundang Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Neostigmine

Sugammadex

Arm Description

At the end of surgery, administrating neostigmine to participants according to the protocol below: when train-of-four (TOF) 2-3, administrating neostigmine 50mcg/kg when TOF 4 with fade, administrating neostigmine 40mcg/kg when TOF 4 without fade, administrating neostigmine 20mcg/kg

At the end of surgery, administrating sugammadex to participants according to the protocol below: when TOF=0 and post-tetanic count (PTC)=1 or more, administrating sugammadex 4mg/kg when TOF=1 or more, administrating sugammadex 2mg/kg when TOF 4 without fade, administrating neostigmine 20mcg/kg

Outcomes

Primary Outcome Measures

the incidence of postoperative residual curarization

definition of postoperative residual curarization: TOF ration is 0.9 or over 0.9

Secondary Outcome Measures

Full Information

NCT ID

NCT03292965

First Posted

September 21, 2017

Last Updated

October 5, 2018

Sponsor

Seoul National University Bundang Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03292965

Brief Title

Monitoring of Postoperative Residual Neuromuscular Blockade in Laparoscopic Surgery

Official Title

Monitoring of Postoperative Residual Neuromuscular Blockade in Laparoscopic Surgery: Comparison of Neostigmine and Sugammadex

Study Type

Interventional

2. Study Status

Record Verification Date

October 2018

Overall Recruitment Status

Completed

Study Start Date

September 28, 2017 (Actual)

Primary Completion Date

November 29, 2017 (Actual)

Study Completion Date

November 29, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Seoul National University Bundang Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Compare the reversal effect of neostigmine and sugammadex using quantitative neuromuscular monitoring

Detailed Description

At the end of surgery, decide the dosage of reversal referring to quantitative neuromuscular monitoring value (TOF). After the administration of reversal, the anesthesiologist who are going to manage the participant should not check the quantitative neuromuscular monitoring and determine the timing of extubation only with his (or her) judgement. After entering post-anaesthesia care unit (PACU) measure the TOF value and check the incidence of TOF ratio > 0.9 between the neostigmine group and sugammadex group.

6. Conditions and Keywords

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

Neuromuscular Block, Residual

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Neostigmine

Arm Type

Active Comparator

Arm Description

Arm Title

Sugammadex

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Neostigmine

Intervention Description

Referring to the randomisation allocation program, participants allocated to group neostigmine, administrate neostigmine as reversal

Intervention Type

Drug

Intervention Name(s)

Sugammadex

Other Intervention Name(s)

Bridion

Intervention Description

Referring to the randomisation allocation program, participants allocated to group sugammadex, administrate sugammadex as reversal

Primary Outcome Measure Information:

Title

the incidence of postoperative residual curarization

Description

definition of postoperative residual curarization: TOF ration is 0.9 or over 0.9

Time Frame

Immediately after entering PACU

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: patients aged over 18 years, planned to undergoing elective laparoscopic surgery under general anesthesia Exclusion Criteria: Obesity BMI over 30 kg/m2 Impairment of renal or/and liver function Allergy to rocuronium, sugammadex (Familial) history of malignant hyperthermia Taking medicines which is affecting neuromuscular function

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

AhYoung Oh, M.D Ph. D

Organizational Affiliation

Department of anesthesiology and pain medicine

Official's Role

Study Chair

Facility Information:

Facility Name

Seoul National University Bundang Hospital

City

Seongnam-si

State/Province

Gyeonggi-do

ZIP/Postal Code

13620

Country

Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

31977627

Citation

Lee YJ, Oh AY, Koo BW, Han JW, Park JH, Hong JP, Seo KS. Postoperative residual neuromuscular blockade after reversal based on a qualitative peripheral nerve stimulator response: A randomised controlled trial. Eur J Anaesthesiol. 2020 Mar;37(3):196-202. doi: 10.1097/EJA.0000000000001157.

Results Reference

derived

Learn more about this trial

Monitoring of Postoperative Residual Neuromuscular Blockade in Laparoscopic Surgery

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