NCT04332627

Brief Summary

The quality of recovery in patients who were reversed neuromuscular blockade by using Sumamadex and Neostigmine in laparoscopic cholecystectomy was compared through the QoR(Quality of Recovery)-15 questionnaire.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
77

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Feb 2020

Shorter than P25 for phase_4

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 24, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 1, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 2, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 21, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 21, 2020

Completed
Last Updated

December 24, 2020

Status Verified

December 1, 2020

Enrollment Period

3 months

First QC Date

April 1, 2020

Last Update Submit

December 22, 2020

Conditions

Neuromuscular Blockade Reversal AgentSugammadexNeostigmineQuality of RecoveryLaparoscopic Cholecystectomy

Outcome Measures

Primary Outcomes (1)

  • Quality of Recovery(QoR)-15 questionnaire score

    the difference of Quality of Recovery(QoR)-15 score between preoperative and postoperative 1 and 2 days (minimum value : 0, maximum value : 150, the higher the score, the better the result)

    preoperative 1 days to postoperative 2 days

Secondary Outcomes (6)

  • recovery time

    perioperative - until 48hours

  • PACU(post-anesthesia care unit) stay time

    perioperative - until 48hours

  • postoperative pain score

    at postoperative 30minutes, 6hours, 24hours

  • the incidence of administration of postoperative rescue drug

    perioperative - until 72hours

  • hospital stay

    preoperative - until discharge (usually 48 hours to 72hours)

  • +1 more secondary outcomes

Study Arms (2)

sugammadex

ACTIVE COMPARATOR

sugammadex 2mg/kg or 4mg/kg according to Train-of-four count (TOF 0 : 4mg/kg, TOF 1-4 : 2mg/kg)

Drug: Sugammadex

neostigmine

PLACEBO COMPARATOR

with glycopyrrolate 0.4mg, neostigmine 0.02mg/kg or 0.04mg/kg or 0.05mg/kg according to Train-of-four count (TOF 0 : wait until TOF 2, TOF2-3: 0.05mg/kg, TOF4: 0.04mg/kg)

Drug: Neostigmine

Interventions

SugammadexDRUG

sugammadex 2mg/kg or 4mg/kg according to Train-of-four count (TOF 0 : 4mg/kg, TOF 1-4 : 2mg/kg)

sugammadex
NeostigmineDRUG

with glycopyrrolate 0.4mg, neostigmine 0.02mg/kg or 0.04mg/kg or 0.05mg/kg according to Train-of-four count (TOF 0 : wait until TOF 2, TOF2-3: 0.05mg/kg, TOF4: 0.04mg/kg)

neostigmine

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients who underwent laparoscopic cholecystectomy aged 20-70

You may not qualify if:

  • neuromuscular disease
  • allergy to rocuronium, sugammadex, neostigmine
  • cognitive impairment ( disable to answer the questionnaire )
  • refuse to participate

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 (2)

  • Stark PA, Myles PS, Burke JA. Development and psychometric evaluation of a postoperative quality of recovery score: the QoR-15. Anesthesiology. 2013 Jun;118(6):1332-40. doi: 10.1097/ALN.0b013e318289b84b.

    PMID: 23411725BACKGROUND

  • Hristovska AM, Duch P, Allingstrup M, Afshari A. Efficacy and safety of sugammadex versus neostigmine in reversing neuromuscular blockade in adults. Cochrane Database Syst Rev. 2017 Aug 14;8(8):CD012763. doi: 10.1002/14651858.CD012763.

    PMID: 28806470BACKGROUND

MeSH Terms

Interventions

SugammadexNeostigmine

Intervention Hierarchy (Ancestors)

gamma-CyclodextrinsCyclodextrinsMacrocyclic CompoundsPolycyclic CompoundsDextrinsStarchGlucansPolysaccharidesCarbohydratesPhenylammonium CompoundsQuaternary Ammonium CompoundsAminesOrganic ChemicalsOnium Compounds

Study Officials

  • Jiwon Han, Ms

    Seoul National University Bundang Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
clinical instructor

Study Record Dates

First Submitted

April 1, 2020

First Posted

April 2, 2020

Study Start

February 24, 2020

Primary Completion

May 21, 2020

Study Completion

May 21, 2020

Last Updated

December 24, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)