Health Condition 1: - Health Condition 2: K839- Disease of biliary tract, unspecified
Conditions
Interventions
Intervention1: Sedation with Ketamine and Dexmedetomidine: Sedation with Inj. Ketamine 0.5mg/kg IV as bolus as per requirement of patient’s body weight over 2-5minutes, clinical response will be asses
Sponsors
Dr Aruna Bharti
Eligibility
Inclusion criteria
Inclusion criteria: 18 to 65 year old ASA I and II patients who have consented to participate in the study
Exclusion criteria
Exclusion criteria: Nonconsenting patients. Patients allergic to egg, allergy to study drugs assessed by prior history Baseline SpO2 BMI >35kg/m2 due to altered drug metabolism and clearance Pregnant and lactating patients. Psychiatric disorders (schizophrenia) as Ketamine is contraindicated in such patients Heart blocks, arrhythmias, Patient with pacemakers Patients with increased intracranial pressure, eg-patients with space occupying lesion in brain, h/o Cerebrovascular Accident in the previous one year Severe liver dysfunction (Child Pugh class C). ASA III and IV are not considered as they have liver dysfunction causing significant side effects of dexmedetomidine due to reduced clearance that requires dose adjustments and increases recovery time.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| comparing the recovery profile between the groups after the procedureTimepoint: awake and recovery time are assessed at the end of the procedure | — |
Secondary
| Measure | Time frame |
|---|---|
| To examine the hemodynamic stability between the groups. Rescue medication requirement during the procedure. Endoscopist’s satisfaction score assessed at the end of the procedure (using 5-point numerical rating scale where 1-excellent, 2-good, 3-satisfied, 4-poor and 5-very poor). Patient satisfaction score assessed 30mins after the end of procedure when MAS of 9 is achieved (using 5 point numerical rating scale where 1-excellent, 2-good, 3-satisfied, 4-poor and 5-very poor is done). Pain assessed with Numerical rating scale (0-10) recorded at 30mins and 6hr post procedure. Adverse events seen during procedure and during recovery. Timepoint: Hemodynamic stability and Rescue medication requirement are recorded during the procedure. Endoscopist’s satisfaction score assessed at the end of the procedure Patient satisfaction score assessed 30mins after the end of procedure when MAS of 9 is achieved Pain assessed with Numerical rating scale (0-10) recorded at 30mins and 6hr post procedure. Adverse events seen during procedure and during recovery. | — |
Countries
India
Contacts
Public ContactDr Divya M
Sanjay Gandhi Post Graduate Institute of Medical Sciences
Outcome results
None listed