Pharmacokinetics of Sugammadex in Reversal of Vecuronium-induced Neuromuscular Blockade in Patients During Laparoscopic Surgery
NCT ID: NCT05328778
Last Updated: 2022-04-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
48 participants
INTERVENTIONAL
2019-07-16
2022-11-30
Brief Summary
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Detailed Description
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Vecuronium was continuous infusing to maintain moderate neuromuscular blockade during the laparoscopic surgery and stopped infusing after the laparoscopic procedure. A single dose administration of sugammadex (Sug) 2.0mg/kg according to ideal body weight (IBW) was given at the reappearance of the second twitch of the train-of-four (TOF) response.
On one hand, venous blood samples were obtained before administration of Sug and at 2, 3, 5, 10, 15, 20, 30, 60 minutes and 2, 4, 6, 8 hours after administration of Sug to determine plasma concentration of Sug using HPLC-MS. On the other hand, time from start of administration of Sug to recovery of TOF ratio to 0.9 and other clinical indicators were also recorded.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Normal Weight group
n=16, 18.5kg/m² ≤ BMI ≤ 24.9kg/m²
Sugammadex
Each patient received a single dose administration of sugammadex 2mg/kg according to the ideal body weight (IBW) at reappearance of the second twitch of the train-of-four (TOF).
Obese group
n=16, 25≤BMI≤39.9kg/m²
Sugammadex
Each patient received a single dose administration of sugammadex 2mg/kg according to the ideal body weight (IBW) at reappearance of the second twitch of the train-of-four (TOF).
Morbidly Obese group
n=16, BMI≥40kg/m²
Sugammadex
Each patient received a single dose administration of sugammadex 2mg/kg according to the ideal body weight (IBW) at reappearance of the second twitch of the train-of-four (TOF).
Interventions
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Sugammadex
Each patient received a single dose administration of sugammadex 2mg/kg according to the ideal body weight (IBW) at reappearance of the second twitch of the train-of-four (TOF).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. BMI≥25kg/m²
3. Patients receiving bariatric surgery.
Exclusion Criteria
2. Neuromuscular diseases
3. Malignant hyperthermia or allergic history during general anesthesia
4. Drugs that react with rocuronium and vecuronium were taken
18 Years
70 Years
ALL
No
Sponsors
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Guangzhou General Hospital of Guangzhou Military Command
OTHER
Responsible Party
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bo xu
Clinical Professor
Locations
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Guangzhou Military Region General Hospital, Department of Anesthesiology
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Laparoscopic Surgery
Identifier Type: -
Identifier Source: org_study_id
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