Health Condition 1: K87- Disorders of gallbladder, biliarytract and pancreas in diseases classified elsewhere
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Patient undergoing ERCP under iv sedation 1)ASA physical status I,II and III 2)Body weight :40 to 70 kg
Exclusion criteria
Exclusion criteria: 1) Allergy or history of adverse reaction to Propofol, Dexmedetomidine or Fentanyl 2) Pregnancy or lactation 3) Anticipated difficult airway 4) Patients with chronic kidney disease, neurological deficit, pre-existing delirium/cognitive dysfunction 5) Evidence of hepatic encephalopathy or ascites 6) Hyponatremia ( 5.5 meq/l) 7) Patient refusal 8) Patients with comorbidities like uncontrolled hypertension, hypotension, uncontrolled diabetes mellitus, congestive cardiac failure, and low cardiac output disorders or arrhythmias.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess and compare the onset of action, the quality of anaesthesia and recovery time produced by Propofol-Fentanyl and Propofol-Dexmedetomidine combinations in patients during ERCP with the help of BIS.Timepoint: Onset of action - after starting Propofol infusion (within 5 min of starting Propofol infusion) Quality of anaesthesia - From 0 min to the procedure ending time Recovery time - From removal of the endoscope to the time when patient becomes awake/ BIS value greater than 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) To compare the hemodynamic changes produced by Propofol-Fentanyl and Propofol-Dexmedetomidine combinations during sedation in ERCP at 0,3,5 and 15 minutes respectively 2) To assess the adverse effects produced by the two combinations 3) To assess and compare the physician/patient satisfaction in each combinations. Timepoint: 0, 3, 5 and 15 minutes after starting Propofol infusion and till one hour post-procedure | — |
Countries
India
Contacts
K S HEGDE MEDICAL ACADEMY