Reversal With Low Doses of Sugammadex in Patients Undergoing Non-cardiac Surgery

NCT03460509 | Unknown Phase 4 DMC

• 1 other identifier: SIVAA01
• Study Type: interventional
• Target: 144
• Locations: 0 countries
• Sites: N/A

Brief Summary

Neuromuscular blocking agents (NMBA) are among the most commonly used drugs during general anesthesia and may induce complete muscle paralysis.They are used clinically to facilitate endotracheal intubation and to optimize surgical working conditions. Incomplete recovery from non-depolarising NMBAs continues to be a common problem in modern postoperative care unit and is associated with significant risk of microaspiration and hypoventilation which leads to pulmonary complications.Recently effective reversal of neuromuscular blockade has been described by use of lower dose of sugammadex the recommended without providing adequate answer to whether the lower dose is safe enough to avoid recurrent block. Hypotheses:

1. 1.Administration of sugammadex 0.25 mg/kg at TOF ratio 0.3 will successfully reverse (TOF=0.9) rocuronium induced neuromuscular block within 10 min.
2. 2.Recurrent block (TOF ratio \< 0.9) does not occur after reversal with low dose sugammadex 0.25 mg/kg.

Conditions

Postoperative Residual Curarization; Neuromuscular Block

Outcome Measures

Primary Outcomes (1)

• The time from study drug administration to reaching a TOF ratio of 0.9.

  10 minutes

Secondary Outcomes (2)

• Number of patient with reoccurrence of neuromuscular block after initial reversal to TOF ratio 0.9.

  20 minutes

• Number of patients with adverse reactions in each group

  until discharge - 3 days

Study Arms (5)

Sugammadex 0 mg/kg

PLACEBO COMPARATOR

Placebo NaCl 0,9%

Drug: Sugammadex

Sugammadex 0,25 mg/kg

ACTIVE COMPARATOR

Sugammadex 0.25 mg/kg IBW

Drug: Sugammadex

Sugammadex 0,5 mg/kg

ACTIVE COMPARATOR

Sugammadex 0.50 mg/kg IBW

Drug: Sugammadex

Sugammadex 1mg/kg

ACTIVE COMPARATOR

Sugammadex 1.0 mg/kg IBW

Drug: Sugammadex

Sugammadex 2mg/kg

ACTIVE COMPARATOR

Sugammadex 2 mg/kg IBW

Drug: Sugammadex

Interventions

Sugammadex DRUG

Dose-response

Sugammadex 0 mg/kg; Sugammadex 0,25 mg/kg; Sugammadex 0,5 mg/kg; Sugammadex 1mg/kg; Sugammadex 2mg/kg

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient, both genders, undergoing any elective in-hospital surgical procedure under general anesthesia requiring rocuronium neuromuscular block.
• ASA I-IV
• Signed informed consent

You may not qualify if:

• Patient less than 18 years of age
• Patient participating in another clinical study which could interfere with TOF trial.
• Patient with neuromuscular disease
• Patient from ICU
• BMI \> 30.0 kg/m2
• Patient scheduled for local or regional anesthesia only
• Patient undergoing general anesthesia without rocuronium
• Patient with hypersensitivity to NMBAs or sugammadex. Also hypersensitivity to any active substance or to any of the following excipient: Hydrochloric acid 3.7% (to adjust pH) and/or sodium hydroxide (to adjust pH) Water for injections .
• Renal dysfunction (GFR\<30 mL/min/1,73m2)
• Hepatic dysfunction
• Patient who have received sugammadex in the last 24 h.
• Bradycardia (puls \<40)
• Hypotension (Systolic BP \<90 mmHg)

Sponsors & Collaborators

• The Hospital of Vestfold: lead

MeSH Terms

Conditions

Delayed Emergence from Anesthesia

Interventions

Sugammadex

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

Central Study Contacts

Tayyba Aslam, MD

CONTACT

004798097489; tayybaaslam@gmail.com

Espen Lindholm, MD, PHD

CONTACT

004792213346; espen.lindholm@siv.no

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: October 17, 2017
• First Posted: March 9, 2018
• Study Start: August 1, 2018
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: May 30, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share