Sugammadex/Neostigmine and Liver Transplantation

NCT02697929 | Completed

• 1 other identifier: SugNeoLTx1.0
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Cirrhotic patients undergoing liver transplantation are at very high risk of post operative complication such as post-operative residual curarization. Rocuronium is a neuromuscular blocking agent that nowadays can be safely and rapidly antagonized with sugammadex. No one study compared sugammadex versus neostigmine after rocuronium infusion during liver transplantation.

Conditions

Postoperative Residual Curarization; Liver Transplantation

Keywords

Rocuronium

Outcome Measures

Primary Outcomes (1)

• Recovery time from moderate neuromuscular block to a TOF ratio more than 0.9 after administration of sugammadex or neostigmine using TOF-Watch SX.

  30 minutes

Secondary Outcomes (1)

• Any episode PORC (defined as TOF ratio less than 0.9) within 20 minutes after extubation of the patient using TOF-Watch SX.

  20 minutes

Study Arms (2)

sugammadex

ACTIVE COMPARATOR

at the end of surgery administration of 2 mg/kg of sugammadex after the third T2 twitch at Train of Four (TOF) stimulation

Drug: sugammadex

neostigmine

ACTIVE COMPARATOR

at the end of surgery administration of 50 mcg/kg of neostigmine after the third T2 twitch at Train of Four (TOF) stimulation

Drug: Neostigmine

Interventions

sugammadex DRUG

sugammadex

Neostigmine DRUG

neostigmine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiology status (ASA) III
• Ability to give a written informed consent
• Liver transplantation

You may not qualify if:

• Any allergy to medications involved in the study
• Any disease involving neuromuscular transmission
• Any therapy with toremifene, flucloxacillin or fusidic acid
• Renal disease with glomerular filtration rate less than 30 ml/min/1.73m2
• Hyperthermia maligna
• Anticonceptional therapy
• Pregnancy
• Core body temperature less than 35°C or skin temperature less than 32°C at the end of surgery

Sponsors & Collaborators

• Azienda Ospedaliera S. Maria della Misericordia: lead

Study Sites (1)

AOU Santa Maria della Misericordia

Udine, 33100, Italy

Location

Related Publications (6)

• Arbous MS, Meursing AE, van Kleef JW, de Lange JJ, Spoormans HH, Touw P, Werner FM, Grobbee DE. Impact of anesthesia management characteristics on severe morbidity and mortality. Anesthesiology. 2005 Feb;102(2):257-68; quiz 491-2. doi: 10.1097/00000542-200502000-00005.

  PMID: 15681938 BACKGROUND

• Craig RG, Hunter JM. Neuromuscular blocking drugs and their antagonists in patients with organ disease. Anaesthesia. 2009 Mar;64 Suppl 1:55-65. doi: 10.1111/j.1365-2044.2008.05871.x.

  PMID: 19222432 BACKGROUND

• van Miert MM, Eastwood NB, Boyd AH, Parker CJ, Hunter JM. The pharmacokinetics and pharmacodynamics of rocuronium in patients with hepatic cirrhosis. Br J Clin Pharmacol. 1997 Aug;44(2):139-44. doi: 10.1046/j.1365-2125.1997.00653.x.

  PMID: 9278198 BACKGROUND

• Khalil M, D'Honneur G, Duvaldestin P, Slavov V, De Hys C, Gomeni R. Pharmacokinetics and pharmacodynamics of rocuronium in patients with cirrhosis. Anesthesiology. 1994 Jun;80(6):1241-7. doi: 10.1097/00000542-199406000-00011.

  PMID: 8010470 BACKGROUND

• Jones RK, Caldwell JE, Brull SJ, Soto RG. Reversal of profound rocuronium-induced blockade with sugammadex: a randomized comparison with neostigmine. Anesthesiology. 2008 Nov;109(5):816-24. doi: 10.1097/ALN.0b013e31818a3fee.

  PMID: 18946293 BACKGROUND

• Deana C, Barbariol F, D'Inca S, Pompei L, Rocca GD. SUGAMMADEX versus neostigmine after ROCURONIUM continuous infusion in patients undergoing liver transplantation. BMC Anesthesiol. 2020 Mar 25;20(1):70. doi: 10.1186/s12871-020-00986-z.

  PMID: 32213163 DERIVED

MeSH Terms

Conditions

Delayed Emergence from Anesthesia

Interventions

Sugammadex; Neostigmine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

gamma-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Polycyclic Compounds; Dextrins; Starch; Glucans; Polysaccharides; Carbohydrates; Phenylammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds

Study Officials

• livia pompei, MD

  AOU Santa Maria Della Misercordia

  PRINCIPAL INVESTIGATOR

• giorgio della rocca, FP, MD

  AOU Santa Maria Della Misercordia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 13, 2016
• First Posted: March 3, 2016
• Study Start: January 1, 2014
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2019
• Last Updated: September 21, 2021

Record last verified: 2021-09

Locations

IT (1)