Health Condition 1: C348- Malignant neoplasm of overlappingsites of bronchus and lung
Conditions
Interventions
Intervention1: Dexmedetomidine bolus + infusion dose with fentanyl rescue: Dexmedetomidine 1 mcg/kg bolus and then 0.2-0.6 mcg/kg infusion. Fentanyl as rescue sedation at 0.5 mcg/kg with doses not exc
Sponsors
Principal Investigator(Anubhab Moulik)
Eligibility
Inclusion criteria
Inclusion criteria: Patients( age 18-65 years) admitted for bronchoscopic biopsy in pulmonary medicine department.
Exclusion criteria
Exclusion criteria: Poor performance status as by Eastern co-operative oncology group performance status ie ECOG 3,4 Patients with diagnosed chronic kidney and chronic liver disease Patients with and at risk of hemodynamic instability defined as heart rate less than 50 and systolic blood pressure less than 90. Known or suspected allergy to any of the trial medications Psychiatric ailments leading to impaired ability to respond to questionnaires and co-operate if necessary during the procedure Pregnancy Patients with known or suspected sleep apnoea Patients with glaucoma Known cases of severe COPD with FEV1 less than 50 percent of predicted Suspected gastrointestinal obstruction including paralytic ileus Baseline oxygen saturation is less than 95 percent. Platelet count less than 50000 for biopsy. Patients deemed unfit for the procedure based on other systemic issues or chronic disease which need time for optimisation. Patients with underlying seizure disorder American society of anaesthesiology(ASA) greater than or equal to class III.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Level of sedation will be assessed using BIS and a 25% difference or effect size is assumed for the experimental arm that is dexmedetomidine arm in comparison to the active control arm which is the midazolam + fentanyl arm. Effect size assumed is 25 % for dexmedetomidine arm with respect to Midazolam+fentanyl arm. Timepoint: Level of sedation will be assessed using BIS in dexmedetomidine arm in comparison to the active control arm which is the midazolam + fentanyl arm. The time points are at start, at vocal cord, at carina, every 5 minutes of the procedure and end of procedure. | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of participants scoring within the target range of modified Ramsay sedation scale(2-4)Timepoint: At start, at vocal cord, at carina, every 5 minutes of the procedure and end of procedure.;Percentage of patients requiring one or more top-up boluses of fentanyl.Timepoint: Time points at which fentanyl top-up was given with dose will be recorded.;Cough score using cough pro app and dividing total number of cough by time in hours.Timepoint: Cough score recorded throughout length of procedure.;To compare overall safety profile of the two treatment arms by keeping record of all complications.Timepoint: Throughout the length of the procedure.;Desaturation defined as saturation less than 90 percent for 15 seconds, hypotension defined as fall in SBP by 20 percent from baseline and bradycardia defined as heart rate less than 60 per minuteTimepoint: Throughout the procedure.;Level of sedation as assessed by composite score.Timepoint: At start, at vocal cord, at carina and at end of the procedure. | — |
Countries
India
Contacts
Public ContactDr. Mahesh R. Jansari
AIIMS KALYANI
Outcome results
None listed