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

Pharmacokinetics Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04131218
• Other study ID #: PK and PD of Sug
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: July 16, 2019
• Est. completion date: July 2020

Study information

• Verified date: March 2020
• Source: Guangzhou General Hospital of Guangzhou Military Command
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: July 2020
• Est. primary completion date: July 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• ASA: ?~?

• BMI=25kg/m²

• Patients receiving bariatric surgery.

Exclusion Criteria:

• Pregnant or lactating women

• Neuromuscular diseases

• Malignant hyperthermia or allergic history during general anesthesia

• Drugs that react with rocuronium and vecuronium were taken

Related Conditions & MeSH terms

• Pharmacodynamics
• Pharmacokinetics

Intervention

Drug:
• 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).

Locations

Country	Name	City	State
China	Guangzhou Military Region General Hospital, Department of Anesthesiology	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangzhou General Hospital of Guangzhou Military Command

Country where clinical trial is conducted

China, 

References & Publications (6)

Asztalos L, Szabó-Maák Z, Gajdos A, Nemes R, Pongrácz A, Lengyel S, Fülesdi 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. — View Citation

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, Ärnlöv 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, Fürst 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, Tabarés-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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma Concentration of Sugammadex	venous blood samples were obtained	0, 2, 3, 5, 10, 15, 20, 30, 60 minutes and 2, 4, 6, 8 hours
Primary	Recovery Time and TOF ratio	time from start of administration of Sug to recovery of TOF ratio to 0.9 and other indicators	TOF ratio at 30, 60, 90, 120, 150 seconds after administration