Health Condition 1: K87- Disorders of gallbladder, biliarytract and pancreas in diseases classified elsewhere
Conditions
Interventions
Intervention1: CLADS-ketamine group: Injection ketamine will be administered at a dose of 0.5 mg/kg after inj fentanyl administration at a dose of 1 g/kg. Following this induction will be started usi
Sponsors
Postgraduate Institute of Medical Education and Research
Eligibility
Inclusion criteria
Inclusion criteria: Age more than equal to 18 Procedural duration more than 20 min
Exclusion criteria
Exclusion criteria: Patients failing to achieve MOAAS less than 2 when BIS of 60 is achieved Age more than 80 BMI more than 35 History of snoring or OSA Allergy to any study drug Hemodynamic instability requiring vasopressors LVEF less than 25 percent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the percentage of valid CLADS time Bispectral Index (BIS) values remain within the target range 60 10 during sedation maintained by Closed Loop Anaesthesia Delivery System for propofol when supplemented with dexmedetomidine versus ketamine.Timepoint: During the ERCP procedural sedation | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of the valid CLADS time for which BIS remains in the range of 60 5.Timepoint: During the ERCP procedural sedation;Performance errorTimepoint: During the ERCP procedural sedation;Median performance errorTimepoint: During the ERCP procedural sedation;Median absolute performance errorTimepoint: During ERCP procedural sedation;Global scoreTimepoint: During the ERCP procedural sedation;WobbleTimepoint: During the ERCP procedural sedation;Hemodynamic stability any fall or increase in blood pressure or heart rate 25% of the baseline parametersTimepoint: During the ERCP procedural sedation;Duration for which heart rate or blood pressure remains 25% of the baselineTimepoint: During the ERCP procedural sedation;Episodes of apnea requiring intervention to maintain the airwayTimepoint: During the ERCP procedural sedation;Total propofol used (mg and mg/kg)Timepoint: During the ERCP procedural sedation;Plasma target concentration of propofol (Marsh model) required to achieve BIS 60Timepoint: During the ERCP procedural sedation;Plasma concentration of propofol required to achieve a BIS of 60Timepoint: During the ERCP procedural sedation;Total dexmedetomidine used ( g and g/kg)Timepoint: During the ERCP procedural sedation;Total ketamine used in mg and mg/kgTimepoint: During the ERCP procedural sedation;Time to awakening in minutesTimepoint: During the ERCP procedural sedation;Patient discomfort during the procedureTimepoint: During the ERCP procedural sedation;Need to give additional intravenous bolus of the study drugsTimepoint: During the ERCP procedural sedation | — |
Countries
India
Contacts
Public ContactVarun Mahajan
Postgraduate Institute of Medical Education and Research
Outcome results
None listed