Safety and efficacy of ketamine-dexmedetomidine combination versus dexmedetomidine alone in cirrhotic patients undergoing upper gastrointestinal-intestinal endoscopy: A prospective controlled clinical trial.
Completed
- Conditions
- Procedural sedation during UGIE in cirrhotic patientsAnaesthesiology - Anaesthetics
- Registration Number
- ACTRN12615000367549
- Lead Sponsor
- South valley university.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 66
Inclusion Criteria
Adult patients aged 18-60years with liver cirrhosis ,child-Pugh score A or B , referred for diagnostic and/ or therapeutic UGIE .
Exclusion Criteria
Age less than 18 or more than 60 years, child- Pugh score C, need for emergency endoscopy ,hemodynamic ally unstable patients, significant cardio-pulmonary disease, hepatic encephalopathy,renal disease,use of sedatives or narcotics one week prior to the endoscopy time,anticipated airway difficulties, allergy to the used drugs.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy: the proportion of complete procedures using the initial proposed sedation scheme . The sedation scheme was considered ineffective when the procedure was interrupted by agitation or intolerance by the patient despite the maximum sedative dose.[At termination of procedure.];Visual Analogue scale(VAS) was used to assess post-operative pain in the recovery period after attaining a modified Aldrete score of less than or equal to 10.[Every 15 min in the first hour and thereafter every 30 min until hospital discharge of patient.]
- Secondary Outcome Measures
Name Time Method -Safety: frequencies of the following complications during procedure or recovery time;hypoxemia,hypotension, bradycardia - liver function tests in the third postoperative day compared with the basal preprocedural level.[Every 2 min During the first 10 min of the procedure and thereafter every 5 min until termination of the procedure.]