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Monitoring of Postoperative Residual Neuromuscular Blockade in Laparoscopic Surgery

Sponsor
Seoul National University Bundang Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03292965
Collaborator
(none)
80
Enrollment
1
Location
2
Arms
2
Actual Duration (Months)
39.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
Monitoring of Postoperative Residual Neuromuscular Blockade in Laparoscopic Surgery: Comparison of Neostigmine and Sugammadex
Actual Study Start Date :
Sep 28, 2017
Actual Primary Completion Date :
Nov 29, 2017
Actual Study Completion Date :
Nov 29, 2017

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Neostigmine

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

Drug: Neostigmine
Referring to the randomisation allocation program, participants allocated to group neostigmine, administrate neostigmine as reversal
Active Comparator: Sugammadex

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

Drug: Sugammadex
Referring to the randomisation allocation program, participants allocated to group sugammadex, administrate sugammadex as reversal
Other Names:
  • Bridion

    		•

    Outcome Measures

    Primary Outcome Measures

    1. the incidence of postoperative residual curarization [Immediately after entering PACU]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Seoul National University Bundang Hospital Seongnam-si Gyeonggi-do Korea, Republic of 13620

    Sponsors and Collaborators

    • Seoul National University Bundang Hospital

    Investigators

    • Study Chair: AhYoung Oh, M.D Ph. D, Department of anesthesiology and pain medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    LEE YEA JI, clinical professor of department of anesthesiology and pain medicine, Seoul National University Bundang Hospital
    ClinicalTrials.gov Identifier:
    NCT03292965
    Other Study ID Numbers:
    • B-1609-363-002
    First Posted:
    Sep 26, 2017
    Last Update Posted:
    Oct 9, 2018
    Last Verified:
    Oct 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Delayed Emergence from Anesthesia
    Neostigmine

    Study Results

    No Results Posted as of Oct 9, 2018