Comparison of Sugammadex and Sugammadex-neostigmine Combination in the Antagonism of Moderate Neuromuscular Block
- Conditions
- Residual Neuromuscular BlockNeuromuscular Blockade Monitoring
- Interventions
- Diagnostic Test: Neuromuscular monitoringOther: reverse of NMB with Sugammadex and neostigmin low doseOther: reverse of NMB with Sugammadex and neostigmin high doseOther: reverse of NMB with sugammadex
- Registration Number
- NCT05228223
- Lead Sponsor
- Ankara City Hospital Bilkent
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 90
- elective general anesthesia
- Female gender
- Between the ages of 18-65
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group SN1 Neuromuscular monitoring Patients reversed with Sugammadex 1mg/kg + Neostigmin 0.02 mg/kg after TOF count is 1-2. Group SN1 reverse of NMB with Sugammadex and neostigmin low dose Patients reversed with Sugammadex 1mg/kg + Neostigmin 0.02 mg/kg after TOF count is 1-2. Group S Neuromuscular monitoring Patients reversed with Sugammadex 2mg/kg after TOF count is 1-2. Grup SN2 Neuromuscular monitoring Patients reversed with sugammadex 1.5 mg/kg + Neostigmin 0.02 mg/kg after TOF count is 1-2. Grup SN2 reverse of NMB with Sugammadex and neostigmin high dose Patients reversed with sugammadex 1.5 mg/kg + Neostigmin 0.02 mg/kg after TOF count is 1-2. Group S reverse of NMB with sugammadex Patients reversed with Sugammadex 2mg/kg after TOF count is 1-2.
- Primary Outcome Measures
Name Time Method Residual curarization rate through study completion an average of 3 months Pecents of Patients TOFR\<0.9
HR through study completion an average of 3 months Heart Rate
SPO2 through study completion an average of 3 months peripheric oxygen saturation
MAP through study completion an average of 3 months Mean arterial pressure
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Ankara City Hospital
🇹🇷Ankara, Turkey