Dexmedetomidine-ketamine Versus Propofol-ketamine for Sedation During Endoscopy in Hepatic Patients

Study Overview
=================
Brief Summary
-----------------
We aim to compare the response to ketamine/dexmedetomidine and ketamine/propofol combinations used in hepatic patients with child-Pugh classification (class A), and early (class B) undergoing UGIE.

Detailed Description
-----------------
70 Patients will be randomly allocated into two groups; Group (KD): Ketamine/dexmedetomidine (35 patients), will receive IV ketamine 0.25mg/kg and dexmedetomidine1µg/kg over 10 min as loading followed by dexmedetomidine infusion with a rate of 0.5µg/kg/hr and Group (KP): ketamine/propofol (35 patients) will receive IV ketamine 0.25 mg/kg loading and propofol 1 mg/kg over 10 min followed by propofol infusion with a rate of 0.5 mg/kg/hr as a control group.

Official Title
-----------------
Dexmedetomidine-ketamine Versus Propofol-ketamine for Sedation During Upper Gastro-intestinal Endoscopy in Hepatic Patients (a Comparative Randomized Study)

Conditions
-----------------
Anesthesia; Reaction

Intervention / Treatment
-----------------
* Drug: Dexmedetomidine
* Drug: Propofol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: hepatic patients with child-Pugh classification (class A), and (class B) American Society of Anesthesiologists physical status II, III aged 18 to 60 years scheduled for elective Upper gastro-intestinal endoscopy. Exclusion Criteria: emergency gastro-intestinal endoscopy. patients with severe hepatic disorder (Child C) , chronic neuro-psychiatric disorder, history of neuro-psychiatric drug intake, severe cardiovascular diseases, pregnancy, history of drug abuse, and history of allergy to any of the used drugs in the study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group KD<br>participants received loading of ketamine 1 mg/kg and dexmedetomidine 1µg/kg over 10 minutes then continue by a dose of 0.25 mg/kg/hr ketamine and 0.25µg/kg/hr dexmedetomidine throughout the procedure. | Drug: Dexmedetomidine<br>* participants received loading of ketamine 1 mg/kg and dexmedetomidine 1µg/kg over 10 minutes then continue by a dose of 0.25 mg/kg/hr ketamine and 0.25µg/kg/hr dexmedetomidine throughout the procedure.<br>* Other names: ketamine;|
| Active Comparator: Group KP<br>participants received loading of ketamine 1 mg/kg and propofol 1 mg/kg over 10 minutes then continue by a dose of 0.25 mg/kg/hr propofol and 0.25 µg/kg/hr dexmedetomidine throughout the procedure. | Drug: Propofol<br>* participants received loading of ketamine 1 mg/kg and propofol 1mg/kg over 10 minutes then continue by a dose of 0.25 mg/kg/hr propofol and 0.25µg/kg/hr dexmedetomidine throughout the procedure.<br>* Other names: ketamine;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| induction time | Time to reach target Ramsay Sedation Score ≥ 3 | after 5 minutes from the start of drug infusion till target Ramsay Sedation Score ≥ 3 is reached | 
| Recovery time | time from the stoppage of drug infusion at the end of the procedure till spontaneous eye opening | after 10 minutes from the stoppage of drug infusion at the end of the procedure till spontaneous eye opening |