Back to resultsEffect of Sugammadex for Reversal of Rocuronium-induced Neuromuscular Block on Perioperative Management of Awake Craniotomy
Primary Purpose
Brain Tumors
Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
sugammadex
Sponsored by
About this trial
This is an interventional treatment trial for Brain Tumors focused on measuring sugammadex、awake craniotomy
Eligibility Criteria
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).
Sites / Locations
- Guangzhou Military Region General Hospital, Department of AnesthesiologyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Sugammadex Group
Control Group
Arm Description
rocuronium-induced general anesthesia，use of sugammadex antagonism
general anesthesia without rocuronium
Outcomes
Primary Outcome Measures
awake time
The time between asleep and awake
Secondary Outcome Measures
Full Information
NCT ID
NCT05202899
First Posted
January 10, 2022
Last Updated
March 7, 2022
Sponsor
Guangzhou General Hospital of Guangzhou Military Command
1. Study Identification
Unique Protocol Identification Number
NCT05202899
Brief Title
Effect of Sugammadex for Reversal of Rocuronium-induced Neuromuscular Block on Perioperative Management of Awake Craniotomy
Official Title
Effect of Sugammadex for Reversal of Rocuronium-induced Neuromuscular Block on Perioperative Management of Awake Craniotomy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
February 28, 2022 (Anticipated)
Study Completion Date
May 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangzhou General Hospital of Guangzhou Military Command
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
Effect of sugammadex for reversal of rocuronium-induced neuromuscular block on Perioperative Management of awake Craniotomy
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Tumors
Keywords
sugammadex、awake craniotomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sugammadex Group
Arm Type
Experimental
Arm Description
rocuronium-induced general anesthesia，use of sugammadex antagonism
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
general anesthesia without rocuronium
Intervention Type
Drug
Intervention Name(s)
sugammadex
Other Intervention Name(s)
Bridion, Org 25969
Intervention Description
The use of sugammadex
Primary Outcome Measure Information:
Title
awake time
Description
The time between asleep and awake
Time Frame
10-30 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
bo xu, DR
Phone
88653387
Ext
020
Email
xubo333@hotmail.com
Facility Information:
Facility Name
Guangzhou Military Region General Hospital, Department of Anesthesiology
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510010
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cong Wei Luo
Phone
18819457246
Email
903740316@qq.com
First Name & Middle Initial & Last Name & Degree
Cong Wei Luo, 86
12. IPD Sharing Statement
Learn more about this trial
Effect of Sugammadex for Reversal of Rocuronium-induced Neuromuscular Block on Perioperative Management of Awake Craniotomy
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