Anesthesia Recovery
Conditions
Brief summary
Prospective Randomized non inferiority Trial involving adult patients undergoing elective surgery under general anesthesia.56 Patients will be enrolled in 2 groups : full dose sugammadex vs half dose sugammadex for reversal of NMB.
Detailed description
The investigators' aim is to prove that half dose sugammadex in combination with neostigmine 0.05 mg/kg is non-inferior to the recommended dose of sugammadex for the reversal of deep ( absence of Trian of Four response :TOF) or moderate ( TOF 1 or 2 twiches) muscle paralysis in patients undergoing surgery under general anesthesia.
Interventions
DRUGSugammadex
half dose
DRUGNeostigmine
IV = 50mcg/kg
DRUGglycopyrrolate
Sponsors
American University of Beirut Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients aged 18-70 * ASA class I, II, and III * undergoing surgery under balanced general anesthesia requiring the use of muscle relaxants throughout the surgery
Exclusion criteria
* patients undergoing emergency surgeries * pregnant patients * patients with end stage renal disease or chronic kidney disease(GFR less than 60) * patients with allergy to sugammadex or who had previous complications or side effects from previous sugammadex administration * patients' refusal * patients with allergy to recuronium
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| TOF ratio of 0.9 | within 5 minutes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the time to return of TOF ratio to 0.9 and the time till extubation | within 10 minutes | — |
| Residual neuro-muscular blockade | within 10 to 180 mins | Post Anesthesia recovery unit |
Countries
Lebanon
Outcome results
None listed