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PharmacokineticsPhase 4NCT04131218

Pharmacokinetics and Pharmacodynamics of Sugammadex in Reversal of Vecuronium-induced Neuromuscular Blockade

A Phase 4 study testing Sugammadex in people with Pharmacokinetics and Pharmacodynamics, run by Guangzhou General Hospital of Guangzhou Military Command at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study is to illustrate pharmacokinetics and pharmacodynamics of sugammadex in reversal of vecuronium-induced neuromuscular blockade in anesthesia obese patients undergoing bariatric surgery. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Pharmacokinetics, Pharmacodynamics
What is being tested?
Sugammadex
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteChina
Study dates
16 Jul 2019to Jul 2020
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 60 years
  • All sexes
  • No healthy volunteers
  • 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

Other trials in China

About this study

Official title: Pharmacokinetics and Pharmacodynamics of Sugammadex in Reversal of Vecuronium-induced Neuromuscular Blockade in Anesthesia Obese Patients Undergoing Bariatric Surgery

The purpose of this study is to illustrate pharmacokinetics and pharmacodynamics of sugammadex in reversal of vecuronium-induced neuromuscular blockade in anesthesia obese patients undergoing bariatric surgery.

Read the detailed description

16 obese patients undergoing bariatric surgery were divided into 2 groups according to body mass index (BMI), including obese group (O group, n=8, 25≤BMI≤39.9kg/m²) and morbidly obese group (M group, n=8, 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.

Being tested
Sugammadex
Keywords
Sugammadex, Obese
Medical subject headings
Obesity

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 groups in NCT04131218
Study groupRoleWhat they receive
Obese groupExperimentaln=8, 25≤BMI≤39.9kg/m²
Receives: Drug: Sugammadex
Morbidly obese groupExperimentaln=8, BMI≥40kg/m²
Receives: Drug: Sugammadex

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

  2. Recovery Time and TOF ratio

    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.

  1. First posted18 Oct 2019
  2. Study start16 Jul 2019
  3. Primary completionJul 2020 (estimated)
  4. Study completionJul 2020 (estimated)

Resources

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
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04131218
Sponsor's protocol ID
PK and PD of Sug
Status last verified
Mar 2020
First submitted
14 Oct 2019
Last updated
31 Mar 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • GBD 2015 Obesity Collaborators; Afshin A, Forouzanfar MH, Reitsma MB, Sur P, Estep K, Lee A, Marczak L, Mokdad AH, Moradi-Lakeh M, Naghavi M, Salama JS, Vos T, Abate KH, Abbafati C, Ahmed MB, Al-Aly Z, Alkerwi A, Al-Raddadi R, Amare AT, Amberbir A, Amegah AK, Amini E, Amrock SM, Anjana RM, Arnlov J, Asayesh H, Banerjee A, Barac A, Baye E, Bennett DA, Beyene AS, Biadgilign S, Biryukov S, Bjertness E, Boneya DJ, Campos-Nonato I, Carrero JJ, Cecilio P, Cercy K, Ciobanu LG, Cornaby L, Damtew SA, Dandona L, Dandona R, Dharmaratne SD, Duncan BB, Eshrati B, Esteghamati A, Feigin VL, Fernandes JC, Furst T, Gebrehiwot TT, Gold A, Gona PN, Goto A, Habtewold TD, Hadush KT, Hafezi-Nejad N, Hay SI, Horino M, Islami F, Kamal R, Kasaeian A, Katikireddi SV, Kengne AP, Kesavachandran CN, Khader YS, Khang YH, Khubchandani J, Kim D, Kim YJ, Kinfu Y, Kosen S, Ku T, Defo BK, Kumar GA, Larson HJ, Leinsalu M, Liang X, Lim SS, Liu P, Lopez AD, Lozano R, Majeed A, Malekzadeh R, Malta DC, Mazidi M, McAlinden C, McGarvey ST, Mengistu DT, Mensah GA, Mensink GBM, Mezgebe HB, Mirrakhimov EM, Mueller UO, Noubiap JJ, Obermeyer CM, Ogbo FA, Owolabi MO, Patton GC, Pourmalek F, Qorbani M, Rafay A, Rai RK, Ranabhat CL, Reinig N, Safiri S, Salomon JA, Sanabria JR, Santos IS, Sartorius B, Sawhney M, Schmidhuber J, Schutte AE, Schmidt MI, Sepanlou SG, Shamsizadeh M, Sheikhbahaei S, Shin MJ, Shiri R, Shiue I, Roba HS, Silva DAS, Silverberg JI, Singh JA, Stranges S, Swaminathan S, Tabares-Seisdedos R, Tadese F, Tedla BA, Tegegne BS, Terkawi AS, Thakur JS, Tonelli M, Topor-Madry R, Tyrovolas S, Ukwaja KN, Uthman OA, Vaezghasemi M, Vasankari T, Vlassov VV, Vollset SE, Weiderpass E, Werdecker A, Wesana J, Westerman R, Yano Y, Yonemoto N, Yonga G, Zaidi Z, Zenebe ZM, Zipkin B, Murray CJL. Health Effects of Overweight and Obesity in 195 Countries over 25 Years. N Engl J Med. 2017 Jul 6;377(1):13-27. doi: 10.1056/NEJMoa1614362. Epub 2017 Jun 12.

    PubMed 28604169

  • Hanley MJ, Abernethy DR, Greenblatt DJ. Effect of obesity on the pharmacokinetics of drugs in humans. Clin Pharmacokinet. 2010;49(2):71-87. doi: 10.2165/11318100-000000000-00000.

    PubMed 20067334

  • Suy K, Morias K, Cammu G, Hans P, van Duijnhoven WG, Heeringa M, Demeyer I. Effective reversal of moderate rocuronium- or vecuronium-induced neuromuscular block with sugammadex, a selective relaxant binding agent. Anesthesiology. 2007 Feb;106(2):283-8. doi: 10.1097/00000542-200702000-00016.

    PubMed 17264722

  • Sanfilippo M, Alessandri F, Wefki Abdelgawwad Shousha AA, Sabba A, Cutolo A. Sugammadex and ideal body weight in bariatric surgery. Anesthesiol Res Pract. 2013;2013:389782. doi: 10.1155/2013/389782. Epub 2013 Jun 6.

    PubMed 23840203

  • Asztalos L, Szabo-Maak Z, Gajdos A, Nemes R, Pongracz A, Lengyel S, Fulesdi B, Tassonyi E. Reversal of Vecuronium-induced Neuromuscular Blockade with Low-dose Sugammadex at Train-of-four Count of Four: A Randomized Controlled Trial. Anesthesiology. 2017 Sep;127(3):441-449. doi: 10.1097/ALN.0000000000001744.

    PubMed 28640017

  • Staals LM, Snoeck MM, Driessen JJ, van Hamersvelt HW, Flockton EA, van den Heuvel MW, Hunter JM. Reduced clearance of rocuronium and sugammadex in patients with severe to end-stage renal failure: a pharmacokinetic study. Br J Anaesth. 2010 Jan;104(1):31-9. doi: 10.1093/bja/aep340.

    PubMed 20007792

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Sugammadex in people with Pharmacokinetics and Pharmacodynamics, 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: status not confirmed, as of the sponsor's last update on 31 Mar 2020. 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?

Results are not available in the source record.

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?

On the ClinicalTrials.gov record for NCT04131218, which also lists 6 linked publications.

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 31 Mar 2020.

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