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

March 7, 2022 updated by: bo xu, Guangzhou General Hospital of Guangzhou Military Command
Effect of sugammadex for reversal of rocuronium-induced neuromuscular block on Perioperative Management of awake Craniotomy

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510010
        • Recruiting
        • Guangzhou Military Region General Hospital, Department of Anesthesiology
        • Contact:
        • Principal Investigator:
          • Cong Wei Luo, 86

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
awake time
Time Frame: 10-30 minutes
The time between asleep and awake
10-30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangzhou General Hospital of Guangzhou Military Command

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2020

Primary Completion (ANTICIPATED)

February 28, 2022

Study Completion (ANTICIPATED)

May 31, 2022

Study Registration Dates

First Submitted

January 10, 2022

First Submitted That Met QC Criteria

January 10, 2022

First Posted (ACTUAL)

January 24, 2022

Study Record Updates

Last Update Posted (ACTUAL)

March 9, 2022

Last Update Submitted That Met QC Criteria

March 7, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Awake Craniotomy

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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