NCT05202899

Brief Summary

Effect of sugammadex for reversal of rocuronium-induced neuromuscular block on Perioperative Management of awake Craniotomy

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2020

Geographic Reach
1 country

1 active site

Status
unknown

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

September 1, 2020

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

January 10, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 24, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2022

Completed
Last Updated

March 9, 2022

Status Verified

March 1, 2022

Enrollment Period

1.5 years

First QC Date

January 10, 2022

Last Update Submit

March 7, 2022

Conditions

Brain Tumors

Keywords

sugammadex、awake craniotomy

Outcome Measures

Primary Outcomes (1)

  • awake time

    The time between asleep and awake

    10-30 minutes

Study Arms (2)

Sugammadex Group

EXPERIMENTAL

rocuronium-induced general anesthesia，use of sugammadex antagonism

Drug: sugammadex

Control Group

NO INTERVENTION

general anesthesia without rocuronium

Interventions

sugammadexDRUG

The use of sugammadex

Also known as: Bridion, Org 25969
Sugammadex Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age: 18-45 years old body mass index (BMI)≥ 18.5-23.9 kg/m2, ASA grade I \~II.

You may not qualify if:

  • Suffering from a mental illness or preoperative communication disorder, patients with claustrophobia, breathing, circulation, neuromuscular system and kidney, and other important viscera function disorder, pregnant or lactating women, a history of malignant hyperthermia, the history of drug allergy in the process of general anesthesia and recent may not used to the interaction between rocuronium, vecuronium bromide reacts drugs (such as aminoglycoside antibiotics, Anticonvulsant, magnesium).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guangzhou Military Region General Hospital, Department of Anesthesiology

Guangzhou, Guangdong, 510010, China

RECRUITING

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Sugammadex

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

gamma-CyclodextrinsCyclodextrinsMacrocyclic CompoundsPolycyclic CompoundsDextrinsStarchGlucansPolysaccharidesCarbohydrates

Central Study Contacts

bo xu, DR

CONTACT

88653387xubo333@hotmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

January 10, 2022

First Posted

January 24, 2022

Study Start

September 1, 2020

Primary Completion

February 28, 2022

Study Completion

May 31, 2022

Last Updated

March 9, 2022

Record last verified: 2022-03

Locations

CN(1)