PharmacokineticsPhase 4NCT05328778
Pharmacokinetics and Pharmacodynamics of Sugammadex Dosed by Corrected Body Weight for Reversal of Vecuronium in Obese Patients
A Phase 4 study testing Sugammadex in people with Pharmacokinetics, run by Guangzhou General Hospital of Guangzhou Military Command at 1 site in China.
Trial summary
The purpose of this study is to illustrate pharmacokinetics of sugammadex in reversal of vecuronium-induced neuromuscular blockade in patients during laparoscopic surgery Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pharmacokinetics
- What is being tested?
- Sugammadex
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 14 Apr 2022to 1 Apr 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA: Ⅰ~Ⅲ
- BMI≥25kg/m²
- Patients receiving bariatric surgery.
Who cannot join
- Pregnant or lactating women
- Neuromuscular diseases
- Malignant hyperthermia or allergic history during general anesthesia
- Drugs that react with rocuronium and vecuronium were taken
Trial locations and contacts
1 site in 1 country.
China1 site
Guangzhou Military Region General Hospital, Department of Anesthesiology
Guangzhou, Guangdong, 510010
About this study
The purpose of this study is to illustrate pharmacokinetics of sugammadex in reversal of vecuronium-induced neuromuscular blockade in patients during laparoscopic surgery
Read the detailed description
48 patients undergoing laparoscopic surgery were divided into 3 groups according to body mass index (BMI), including normal weight group(A group,n=16,18.5kg/m² ≤ BMI ≤ 24.9kg/m²),obese group (B group, n=16, 25≤BMI≤39.9kg/m²) and morbidly obese group (C group, n=16, BMI≥40kg/m²).
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
- Pharmacokinetics
- Being tested
- Sugammadex
- Keywords
- Sugammadex, Laparoscopic Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SugammadexDrug
Also called Bridion, Org 25969
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).
| Study group | Role | What they receive |
|---|---|---|
| Normal Weight group | Experimental | n=16, 18.5kg/m² ≤ BMI ≤ 24.9kg/m² Receives: Drug: Sugammadex |
| Obese group | Experimental | n=16, 25≤BMI≤39.9kg/m² Receives: Drug: Sugammadex |
| Morbidly Obese group | Experimental | n=16, BMI≥40kg/m² Receives: Drug: Sugammadex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma Concentration of Sugammadex
venous blood samples were obtained
Measured: 0, 2, 3, 5, 10, 15, 20, 30, 60 minutes and 2, 4, 6, 8 hours
TOF ratio of Recovery Time
time from start of administration of Sug to recovery of TOF ratio to 0.9 and other indicators
Measured: TOF ratio at 30, 60, 90, 120, 150 seconds after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2022
- Study start14 Apr 2022
- Primary completion1 Jan 2025
- Study completion1 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacokineticsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangzhou General Hospital of Guangzhou Military Command
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, bo xu, Guangzhou General Hospital of Guangzhou Military Command
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05328778
- Sponsor's protocol ID
- Laparoscopic Surgery
- Status last verified
- Apr 2026
- First submitted
- 4 Mar 2022
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics and Pharmacodynamics of Sugammadex Dosed by Corrected Body Weight for Reversal of Vecuronium in Obese Patients
- ClinicalTrials.gov ID
- NCT05328778
- Acronym / sponsor ID
- Laparoscopic Surgery
- Conditions
- Pharmacokinetics
- Keywords
- Sugammadex, Laparoscopic Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Guangzhou General Hospital of Guangzhou Military CommandUniversity, hospital or other
- Study start
- 14 Apr 2022 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 1 Apr 2026 (actual)
- First posted
- 14 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to illustrate pharmacokinetics of sugammadex in reversal of vecuronium-induced neuromuscular blockade in patients during laparoscopic surgery
Detailed description
48 patients undergoing laparoscopic surgery were divided into 3 groups according to body mass index (BMI), including normal weight group(A group,n=16,18.5kg/m² ≤ BMI ≤ 24.9kg/m²),obese group (B group, n=16, 25≤BMI≤39.9kg/m²) and morbidly obese group (C group, n=16, BMI≥40kg/m²).
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normal Weight group | Experimental | Drug: Sugammadexn=16, 18.5kg/m² ≤ BMI ≤ 24.9kg/m² |
| Obese group | Experimental | Drug: Sugammadexn=16, 25≤BMI≤39.9kg/m² |
| Morbidly Obese group | Experimental | Drug: Sugammadexn=16, BMI≥40kg/m² |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA: Ⅰ~Ⅲ
- BMI≥25kg/m²
- Patients receiving bariatric surgery.
Key exclusion criteria (4 listed)
- Pregnant or lactating women
- Neuromuscular diseases
- Malignant hyperthermia or allergic history during general anesthesia
- Drugs that react with rocuronium and vecuronium were taken
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SugammadexAlso: Bridion, Org 25969Each 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). | Drug | Morbidly Obese group, Normal Weight group, Obese group |
Primary outcome
Plasma Concentration of Sugammadex
Time frame: 0, 2, 3, 5, 10, 15, 20, 30, 60 minutes and 2, 4, 6, 8 hours
venous blood samples were obtained
TOF ratio of Recovery Time
Time frame: TOF ratio at 30, 60, 90, 120, 150 seconds after administration
time from start of administration of Sug to recovery of TOF ratio to 0.9 and other indicators
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sugammadex in people with Pharmacokinetics, run by Guangzhou General Hospital of Guangzhou Military Command at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma Concentration of Sugammadex (time frame: 0, 2, 3, 5, 10, 15, 20, 30, 60 minutes and 2, 4, 6, 8 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.