NCT06632067

Brief Summary

This study is to invastigate if patients treated with sugammadex compared to neostigmine/atropine would be extubate faster upon emergence of anesthesia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
262

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2023

Shorter than P25 for all trials

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

August 1, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2023

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

October 6, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 8, 2024

Completed
Last Updated

October 8, 2024

Status Verified

October 1, 2024

Enrollment Period

1 month

First QC Date

October 6, 2024

Last Update Submit

October 6, 2024

Conditions

Keywords

sugammadexgeneral anesthesiaophthalmologic surgical procedures

Outcome Measures

Primary Outcomes (2)

  • Time From reversal to extubation

    Time From reversal to extubation

    Time From reversal to extubation

  • Time From the end of surgery to reversal

    Time From the end of surgery to reversal

    Time From the end of surgery to reversal

Secondary Outcomes (1)

  • Time From induction to the end of surgery

    Time From induction to the end of surgery

Study Arms (2)

sugammadex

those who use sugammadex for reversal of neuromuscular blockade

Drug: sugammadex

neostigmine

those who use neostigmine/atroping for reversal of neuromuscular blockade

Drug: Neostigmine + Atropine

Interventions

sugammadex used for neuromuscular reversal

sugammadex

Neostigmine and Atropine used for neuromuscular reversal

neostigmine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This study included patients aged 18 years or older who underwent ophthalmic surgeries under general anesthesia with tracheal intubation between 2020 and 2022. Patients who received rocuronium as the sole neuromuscular blocking agent and were maintained with sevoflurane or desflurane and intravenous fentanyl were included. Based on the choice of reversal agent for neuromuscular blockade, patients were divided into two groups: the sugammadex group or the neostigmine group. Patients who underwent emergency surgery or combined surgeries with other specialties were excluded.

You may qualify if:

  • aged 18 years or older ophthalmic surgeries under general anesthesia with tracheal intubation between 2020 and 2022 received rocuronium as the sole neuromuscular blocking agent maintained with sevoflurane or desflurane and intravenous fentanyl

You may not qualify if:

  • emergency surgery combined surgeries with other specialties

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China Medical University Hospital

Taichung, 404327, Taiwan

Location

MeSH Terms

Interventions

SugammadexNeostigmineAtropine

Intervention Hierarchy (Ancestors)

gamma-CyclodextrinsCyclodextrinsMacrocyclic CompoundsPolycyclic CompoundsDextrinsStarchGlucansPolysaccharidesCarbohydratesPhenylammonium CompoundsQuaternary Ammonium CompoundsAminesOrganic ChemicalsOnium CompoundsAtropine DerivativesTropanesAzabicyclo CompoundsAza CompoundsBelladonna AlkaloidsSolanaceous AlkaloidsAlkaloidsHeterocyclic CompoundsBridged Bicyclo Compounds, HeterocyclicHeterocyclic Compounds, Bridged-Ring

Study Officials

  • Yi-Ying Chiang, MD

    China Medical Univerity Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 6, 2024

First Posted

October 8, 2024

Study Start

August 1, 2023

Primary Completion

August 31, 2023

Study Completion

August 31, 2023

Last Updated

October 8, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations