Neuromuscular Block Clinical Trial
Official title:
A Randomized Double Blind Trial Comparing Reversal With Low Doses Of Sugammadex aFter Rocuronium-induced Neuromuscular Block Under General Anesthesia in Patients Undergoing Non-cardiac Surgery(TOF TRIAL)
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. 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. Recurrent block (TOF ratio < 0.9) does not occur after reversal with low dose sugammadex
0.25 mg/kg.
The primary objective of this trial is to assess the dose-response characteristics of
sugammadex in reversing rocuronium induced neuromuscular block and to identify the minimal
effective dose
Secondary objective is to assess the safety of different doses of sugammadex (recurrent block
(TOF ratio < 0.9) after reversal and the occurrence of adverse reactions)
Sugammadex is a very expensive drug which limits its use i anaesthesia department. By
optimising drug dosage it may have economic impact and contribute to a wider use of
sugammadex to reverse neuromuscular block before extubation and thus avoid incomplete
recovery. This may lead to less risk for postoperative pulmonary complications and thereby
reduce morbidity and mortality after surgery.
Status | Not yet recruiting |
Enrollment | 144 |
Est. completion date | December 2019 |
Est. primary completion date | December 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility |
Inclusion Criteria: - Patient, both genders, undergoing any elective in-hospital surgical procedure under general anesthesia requiring rocuronium neuromuscular block. - ASA I-IV - Signed informed consent Exclusion Criteria: - 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. - Pregnant or breastfeeding woman. Women in childbearing age must have a negative pregnant test before inclusion. - Bradycardia (puls <40) - Hypotension (Systolic BP <90 mmHg) |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
The Hospital of Vestfold |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The time from study drug administration to reaching a TOF ratio of 0.9. | 10 minutes | ||
Secondary | Number of patient with reoccurrence of neuromuscular block after initial reversal to TOF ratio 0.9. | 20 minutes | ||
Secondary | Number of patients with adverse reactions in each group | Adverse reactions (anaphylactic reaction, flushing, urticaria, erythematous rash, (severe) hypotension (BPsyst> 75 mmHg), tachycardia (heart rate> 120 beats/min), bradycardia (heart rate <40 beats/min), swelling of tongue, swelling of pharynx, bronchospasm) | until discharge - 3 days |
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