Health Condition 1: O- Medical and Surgical
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: ASA I and II Undergoing elective ERCP procedure
Exclusion criteria
Exclusion criteria: Patients with allergies to study drugs Patients refusal to participate in the study Patients with allergies to study drugs pregnant patients Patients with neurological or psychiatric conditions Patients with anticipated difficult airway or OSA Patients with glaucoma Patients with uncontrolled systemic diseases
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patient movementTimepoint: At the time of endoscopic insertion | — |
Secondary
| Measure | Time frame |
|---|---|
| Onset time of the target sedationTimepoint: at the time of attaining an RSS score of 4 or more;Requirement of rescue analgesia (timing and amount)Timepoint: NIL;Total amount of study drugs being usedTimepoint: NIL;HR, MAP, SpO2, RR, RSS & BISTimepoint: At Baseline (T0), at the time of attaining an RSS score of 4 or more (T1), at the time of insertion of the endoscope (T2), at 5 minutes from T1 (T3), at 10 minutes from T1 (T4), at 20 minutes from T1 (T5), at 30 minutes from T1 (T6), at the time of withdrawal of the endoscope (T7), before shifting to the recovery room (T8), & at the time of attaining a modified Aldrete score of 9 or more, excluding BIS (T9);Patient movement at the time of removal of the endoscopeTimepoint: NIL;Recovery timeTimepoint: time from the end of the ERCP procedure to attain a modified Aldrete score of 9 or more;Assess the overall satisfaction of the endoscopist and patient as well as pain and procedure memory scoreTimepoint: NIL;Total duration of the anaesthesia and intervention procedureTimepoint: NIL;Peri-procedural complications (Desaturation, Hypotension/Hypertension, Bradycardia, Myoclonus, Nausea and Agitation)Timepoint: NIL | — |
Countries
India
Contacts
Post Graduate Institute of Medical Education and Research