Health Condition 1: T481- Poisoning by, adverse effect of and underdosing of skeletal muscle relaxants [neuromuscular blocking agents]
Conditions
Interventions
Intervention1: Sugammadex: Sugammadex will be administered in a dose of 2mg/kg intravenously followed by additional bolus of 2mg/kg if no change in the Train of four with maximum dose limited to 4mg/k
Sponsors
ICMR
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients on invasive mechanical ventilation Received neuromuscular blocker infusion, rocuronium or vecuronium at least for 6hrs, or received two or more doses of NMBA, excluding the dose received during intubation. 2. The decision of stopping of NMBA infusion/bolus has been taken by the clinical team and there is no longer requirement of NMB as per the evaluation.
Exclusion criteria
Exclusion criteria: Exclusion criteria 1.Pregnancy 2.Lactation 3.any known allergy to sugammadex. 4.Patients with decision of limitation of care based on shared decision-making process or severe multiorgan failure with chances of survival less than 48 hrs will be excluded. 5. Patients with neuromuscular weakness, diagnosed with critical illness neuromyopathy or any other preexisting neurological or neuromuscular illness that can interfere with assessment. 6. Patients transferred from another healthcare facility with neuromuscular weakness or without reliable details of previous medications. 7. Patients who have received invasive mechanical ventilation in the current admission and extubated and readmitted to ICU. 8. Patients who are on implantable devices such as pacemaker or implantable cardiac defibrillator 9.Patients with clinical signs of spontaneous recovery from NMB, sustained eye opening, head lift, limb movement, breathing CPAP Continuous positive airway pressure or Pressure Support-Positive end expiratory pressure PS-PEEP mode will be excluded or as determined by TOF 4/4 and Quantitative more than or equal to 0.9 will be excluded. 10.Patients with creatinine clearance less than 30ml per min and patient is not on renal replacement therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the time to extubation between sugammadex and control group at day 14 after the administration of study drug/placebo.Timepoint: Outcome will be assessed within 14 days after the administration of study drug/placebo | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the length of ICU stay in the sugammadex & the control group at day 28. Timepoint: Outcome will be assessed at day 28 after the randomization.;To compare the incidence of ICU-acquired weakness in the sugammadex & control groups within 28 days.Timepoint: Outcome will be assessed within 28 days after the randomization.;To compare the number of ventilator-free days between the two groups at 28days.Timepoint: Outcome will be assessed at day 28 after randomization.;To compare the time taken for change of mode from assist-controlled to PS-PEEP/CPAP mode & extubation during 28 daysTimepoint: Outcome will be assessed within 28 days after randomization.;To assess health economics parameters among the two groups includes cost benefit, cost utility & cost effectiveness analysis using incremental cost effectiveness ratio, ICER at day 28.Timepoint: Outcome will assessed at day 28 after randomization. | — |
Countries
India
Contacts
Public ContactDr Amarja Havaldar
St Johns medical college
Outcome results
None listed