The ED95 Dose of Sugammadex to Reverse Rocuronium-Induced Deep Neuromuscular Block Back to Shallow Neuromuscular Block

NCT05841316 | Unknown

• 1 other identifier: 95
• Study Type: observational
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

In the European Society of Anaesthesiology and Intensive Care (ESAIC) guideline on the use of neuromuscular blockers published in 2023, it was suggested that sugammadex could be used to reverse deep and moderate neuromuscular blockade, and that neostigmine could be used to reverse superficial neuromuscular block (expressed as Train-of-Four Ratio (TOFR) 0.4 and above) to TOFR 0.9. Therefore, it has been hypothesized that a transition from deep neuromuscular block to superficial neuromuscular block can be achieved with lower than standard dose of sugammadex, followed by usual dose of neostigmine which results complete neuromuscular recovery from superficial neuromuscular block. This study is planned with 2 stages. In the first phase of the study, the main goal is to determine the dose of sugammadex that would reverse the rocuronium induced deep neuromuscular block (PTC 1 to 3) to superficial neuromuscular block (TOFR: 0.4) in 95% of patients in 5 minutes following administration.

Conditions

Deep Neuromuscular Blockade; Anesthesia, General

Keywords

neuromuscular block; sugammadex; ED95; rocuronium

Outcome Measures

Primary Outcomes (1)

• ED95 of sugammadex

  The dose of sugammadex to provide reversal from deep to superficial rocuronium induced neuromuscular blockade in 5 minutes after bolus administration in 95% of patients

  5 minutes

Study Arms (1)

Sugammadex ED95%

Sugammadex 0.6 mg/kg will be given in the first patient. The primary outcome is the success of recovery from deep (PTC:1-3) to superficial neuromuscular block (TOFR: 0.4) in 5 minutes after the administration of sugammadex. In case of success, the next patient will be given the same or reduced dose of 0.2 mg/kg sugammadex according to the randomisation scheme. In case of failure, the next patient will be given an increased dose of 0.2 mg/kg sugammadex.

Drug: Sugammadex

Interventions

Sugammadex DRUG

During the surgery, the desired level of neuromuscular block will be deep and followed by post-tetanic-count (PTC) of 1 to 3 in every 5 minutes. 0.3-1mg/kg/h rocuronium will be infused to ensure PTC of 1 to 3. At the end of the surgery, 0,6 mg sugammadex will be given as a bolus in the first patient of the study. The duration between the completion of sugammadex injection and the first measurement of Train-of-four ratio (TOFR) of 0.4 will be recorded. If the TOFR is achieved to 0.4 after sugammadex bolus of 0,6 mg/kg in 5 minutes, the result of reversal will be evaluated as positive. The consecutive patient will be given the same or decreased dose of sugammadex by 0,2 mg/kg according to the randomisation scheme. If the patient fails to recover from deep neuromuscular block to superficial block in 5 minutes after a given dose of sugammadex, the consecutive patient will be administered increased dose of sugammadex by 0,2 mg/kg.

Sugammadex ED95%

Eligibility Criteria

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

Study Population

All ASA 1 and 2 patients undergoing elective surgery with normal BMI

You may qualify if:

• BMI: 18.5-24.9 kg/m2
• ASA 1 and 2
• Patients undergoing elective surgery

You may not qualify if:

• Allergic reactions to study drugs
• Planned rapid sequence anesthesia induction
• Patient refusal
• Emergence surgery
• Neuromuscular diseases
• Renal disease or failure with elevated creatinine above 2.0 mg/dL
• Liver failure

Sponsors & Collaborators

• Ankara University: lead

Related Publications (4)

• Fuchs-Buder T, Schmartz D, Baumann C, Hilt L, Nomine-Criqui C, Meistelman C, Brunaud L. Deep neuromuscular blockade improves surgical conditions during gastric bypass surgery for morbid obesity: A randomised controlled trial. Eur J Anaesthesiol. 2019 Jul;36(7):486-493. doi: 10.1097/EJA.0000000000000996.

  PMID: 30985536 RESULT

• Chen S, Zhang Y, Che L, Shen L, Huang Y. Risk factors for unplanned reintubation caused by acute airway compromise after general anesthesia: a case-control study. BMC Anesthesiol. 2021 Jan 12;21(1):17. doi: 10.1186/s12871-021-01238-4.

  PMID: 33435881 RESULT

• Banik RK, Honeyfield K, Qureshi S, Reddy SG. Incidence and Mortality Rate of Perioperative Reintubation: Case Series of 196 Patients. AANA J. 2021 Dec;89(6):476-479.

  PMID: 34809752 RESULT

• Fuchs-Buder T, Romero CS, Lewald H, Lamperti M, Afshari A, Hristovska AM, Schmartz D, Hinkelbein J, Longrois D, Popp M, de Boer HD, Sorbello M, Jankovic R, Kranke P. Peri-operative management of neuromuscular blockade: A guideline from the European Society of Anaesthesiology and Intensive Care. Eur J Anaesthesiol. 2023 Feb 1;40(2):82-94. doi: 10.1097/EJA.0000000000001769. Epub 2022 Nov 15.

  PMID: 36377554 RESULT

MeSH Terms

Interventions

Sugammadex

Intervention Hierarchy (Ancestors)

gamma-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Polycyclic Compounds; Dextrins; Starch; Glucans; Polysaccharides; Carbohydrates

Central Study Contacts

Menekse Ozcelik, MD

CONTACT

+905333521400; ozcelikmenekse@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 22, 2023
• First Posted: May 3, 2023
• Study Start: October 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: August 9, 2023

Record last verified: 2023-08