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Effect of Sugammadex for Reversal of Rocuronium-induced Neuromuscular Block on Perioperative Management of Awake Craniotomy

Sponsor
Guangzhou General Hospital of Guangzhou Military Command (Other)
Overall Status
Recruiting
CT.gov ID
NCT05202899
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
20.9
Anticipated Duration (Months)
1.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effect of Sugammadex for Reversal of Rocuronium-induced Neuromuscular Block on Perioperative Management of Awake Craniotomy
Actual Study Start Date :
Sep 1, 2020
Anticipated Primary Completion Date :
Feb 28, 2022
Anticipated Study Completion Date :
May 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Sugammadex Group

rocuronium-induced general anesthesia，use of sugammadex antagonism

Drug: sugammadex
The use of sugammadex
Other Names:
  • Bridion
  • Org 25969

    		•
    No Intervention: Control Group

    general anesthesia without rocuronium

    Outcome Measures

    Primary Outcome Measures

    1. awake time [10-30 minutes]

      The time between asleep and awake

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Age: 18-45 years old body mass index (BMI)≥ 18.5-23.9 kg/m2, ASA grade I ~II.
    Exclusion Criteria:
    • 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).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Guangzhou Military Region General Hospital, Department of Anesthesiology Guangzhou Guangdong China 510010

    Sponsors and Collaborators

    • Guangzhou General Hospital of Guangzhou Military Command

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    bo xu, Clinical Professor, Guangzhou General Hospital of Guangzhou Military Command
    ClinicalTrials.gov Identifier:
    NCT05202899
    Other Study ID Numbers:
    • Awake Craniotomy
    First Posted:
    Jan 24, 2022
    Last Update Posted:
    Mar 9, 2022
    Last Verified:
    Mar 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by bo xu, Clinical Professor, Guangzhou General Hospital of Guangzhou Military Command
    sugammadex、awake craniotomy
    Additional relevant MeSH terms:
    Brain Neoplasms

    Study Results

    No Results Posted as of Mar 9, 2022