Neuromuscular Blockade Monitoring, Residual Neuromuscular Block
Conditions
Keywords
Sugammadex, Neostigmine, Neuromuscular Blockade Monitoring, Postoperative Nausea and Vomiting, Delayed Emergence from Anesthesia, Postoperative Complications, Rocuronium, Residual Neuromuscular Block
Brief summary
In this prospective randomized controlled study the investigators compare the sugammadex-neostigmine combination and single dose sugammadex in terms of side effects and cost for the antagonism of moderate neuromuscular block induced by rocuronium.
Detailed description
Sugammadex is a novel drug used to reverse neuromuscular blockade. It shows its effect by binding with steroid neuromuscular agents at a ratio of 1:1. Compared to anticholinesterase and other neuromuscular reverse agents, sugammadex shows less cholinergic side effects and less residual muscle relaxation. Besides all these, sugammadex reverses neuromuscular blockade very quickly. In addition to these benefits, it has side effects such as hypersensitivity and this side effect can be seen more at high doses. In addition, sugammadex is more costly than other neuromuscular reverse agents. In this prospective randomized controlled study the investigators compare the sugammadex-neostigmine combination and single dose sugammadex in terms of side effects and cost for the antagonism of moderate neuromuscular block induced by rocuronium.
Interventions
DIAGNOSTIC_TESTNeuromuscular monitoring
TOF monitoring
OTHERreverse of NMB with sugammadex
Patients reversed with Sugammadex 2mg/kg after TOF count is 1-2.
OTHERreverse of NMB with Sugammadex and neostigmin low dose
Patients reversed with Sugammadex 1mg/kg + Neostigmin 0.02 mg/kg
OTHERreverse of NMB with Sugammadex and neostigmin high dose
patients reversed with sugammadex 1.5 mg/kg + Neostigmin 0.02 mg/kg
Sponsors
Ankara City Hospital Bilkent
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
Prospective randomized controlled double blind study
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* elective general anesthesia * Female gender * Between the ages of 18-65
Exclusion criteria
* ASA ≥ 3 * Pregnancy * Contraindication to use of anesthetic drugs * Kidney failure * Liver failure * Heart failure * BMI \<18 and BMI \> 35 kg/m2 * anticipated difficult airway * neuromuscular disease * Use of drugs that impair neuromuscular transmission * Patients who develop unexpected massive hemorrhage * Those who do not have the ability to read, understand and sign the consent form * Refusal of patient
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Residual curarization rate | through study completion an average of 3 months | Pecents of Patients TOFR\<0.9 |
| SPO2 | through study completion an average of 3 months | peripheric oxygen saturation |
| MAP | through study completion an average of 3 months | Mean arterial pressure |
| HR | through study completion an average of 3 months | Heart Rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PONV | through study completion an average of 3 months | Postoperative nausea and vomiting |
| Time to Return of bowel movements | through study completion an average of 3 months | when patients' bowel movements return |
Countries
Turkey (Türkiye)
Contacts
Primary ContactAysun Postacı
Backup ContactRıdvan Durgut
Outcome results
None listed