Health Condition 1: O- Medical and Surgical Health Condition 2: 8- Other Procedures
Conditions
Interventions
Intervention1: Inhaled group (SedaConDa ACD): Inhaled for sedation with SedaConDa ACD using continuous infusion of isoflurane.
After an initial bolus of 1 to 1.5 ml and an infusion will be started (ra
Midazolam boluses of 1 ââ?¬â?? 2mg till desired RASS
Control Intervention2: Dexmedetomidine group: Continuous intravenous infusion of dexmedetomidine.e (intravenous) diluted to 10mcg/mL. The drug wil
Sponsors
Tata Memorial Hospital
Indian Society of Critical Care Medicine ISCCM
Eligibility
Inclusion criteria
Inclusion criteria: 1.Age 18-80 years 2.BMI 25 to 35 Kg/m2 3.Anticipated Mechanical ventilation for > 24 hrs. 4.Patients who are mechanically ventilated within 48hrs of ICU admission 5.Hemodynamically stable patients (i.e., MAP >65mmHg) with or without vasoactive agents. 6.RASS score -1 to +4 on opioid infusion 7.Patients / surrogate decision maker, willing to enroll in the trial by giving written informed consent. We shall ask for provision of deferred informed consent from the respective IECs.
Exclusion criteria
Exclusion criteria: 1.Patients who as per clinicianââ?¬•s judgement, need deep sedation (RASS -4 or deeper) such as those with severe head injury (GCS 2.Malnourished or morbidly obese patients (35 > BMI 3.Need for neuromuscular blocking agents either as repeated boluses or infusion 4.Contraindications to use of HME filter during mechanical ventilation, these may include, but not limited to: excessive secretions or pulmonary hemorrhage likely to block the filter, indications for reducing apparatus dead space, such as respiratory acidosis 5.Ventilation with Tidal volume below 200 ml 6.Pregnant or breast-feeding women. 7.Family or personal history of malignant hyperthermia. 8.Patients already receiving sedation for more than > 48 hours. 9.Refusal of consent or withdrawal of consent for use of data. 10.Need for elective postoperative ventilation for 11.Patients with substance abuse, deliberate self harm or any condition that warrants administration of any of the study drugs or any drug that belong to the study drug classification.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of delirium in critically ill mechanically ventilated patients during their ICU stayTimepoint: 1. 1st 24 hours of stopping sedation 2. 7 days of stopping sedation 3. At 30 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Time to awakening after stopping the sedation 2.Time to cognitive arousal i.e. following simple verbal commands such as tongue protrusion, eye-opening and closing, handgrip 3.Incidence of delirium within first 24 hours of stopping sedation 4.Delirium-free days after stopping the sedation, within 7 days after weaning or at discharge 5.The proportion of time spent between Richmond Agitation Sedation Scale scores of -2 to -3 6.Need for additional sedation to achieve target sedation levels 7.Decreased need for opioid infusion dose 8.Need for commencement of new vasopressor agents to achieve and maintain target MAP 9.Incidence hemodynamic adverse effects such as bradycardia, hypotension, the onset of new arrhythmias, and others, if any 10.Incidence of renal, hepatic, adverse effects, if any 11.Need for rescue analgesia 12.Any other complications 13.Status at ICU discharge 14.Status at 30 days or at Hospital dischargeTimepoint: 1. 1st 24 hours of stopping sedation 2. 7 days of stopping sedation 3. At 30 days | — |
Countries
India
Contacts
Public ContactDr Atul Kulkarni
Tata Memorial Hospital
Outcome results
None listed