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Trial registered on ANZCTR
Registration number
ACTRN12615000367549
Ethics application status
Approved
Date submitted
31/12/2014
Date registered
22/04/2015
Date last updated
22/04/2015
Type of registration
Retrospectively registered
Titles & IDs
Public title
Safety and efficacy of ketamine-dexmedetomidine combination versus dexmedetomidine alone in cirrhotic patients undergoing upper gastrointestinal-intestinal endoscopy: A prospective controlled clinical trial.
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Scientific title
Safety and Efficacy of Ketamine-dexmedetomidine versus dexmedetomidine alone in cirrhotic patients undergoing upper gastrointestinal endoscopy.
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Secondary ID [1]
285903
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Nil
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Universal Trial Number (UTN)
U 1111-1165-6212
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Procedural sedation during UGIE in cirrhotic patients
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Condition category
Condition code
Anaesthesiology
294123
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0
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Anaesthetics
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
GroupI(n=30):received I. V. Ketamine in a dose of 1 mg/ kg at induction of anesthesia followed by infusion of dexmedetomidine(dex) in a rate of 0.2-0.6ug/kg/hr till termination of endoscopy, while GroupII(n=30) received only a continuous infusion of dex. at induction of anesthesia in a rate of 0.2-0.6ug/kg/hr guided by BIS range of 50-70 till termination of endoscopy. In both groups,fentanyl 25 ug/ kg was used I.V as rescue sedoanalgesic when required
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Intervention code [1]
290879
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Treatment: Drugs
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Comparator / control treatment
The comparator/control treatment group is ketamine/dexmedetomidine group
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Control group
Active
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Outcomes
Primary outcome [1]
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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.
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Timepoint [1]
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At termination of procedure.
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Primary outcome [2]
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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.
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Timepoint [2]
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Every 15 min in the first hour and thereafter every 30 min until hospital discharge of patient.
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Secondary outcome [1]
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-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.
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Timepoint [1]
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Every 2 min During the first 10 min of the procedure and thereafter every 5 min until termination of the procedure.
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Eligibility
Key inclusion criteria
Adult patients aged 18-60years with liver cirrhosis ,child-Pugh score A or B , referred for diagnostic and/ or therapeutic UGIE .
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Minimum age
18
Years
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Maximum age
60
Years
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Gender
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
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Type of endpoint(s)
Safety/efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
2/06/2014
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Actual
7/06/2014
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Date of last participant enrolment
Anticipated
2/12/2014
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Actual
20/12/2014
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
66
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
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Egypt
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State/province [1]
6573
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Qena
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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South valley university( SVU).
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Address [1]
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SVU-Qena- postal code 85823
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Country [1]
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Egypt
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Primary sponsor type
University
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Name
South valley university.
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Address
SVU-Qena-postal code 85823
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Country
Egypt
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Secondary sponsor category [1]
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None
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Name [1]
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Nil
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Address [1]
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Nil
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Country [1]
289185
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Ethics approval
Ethics application status
Approved
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Summary
Brief summary
Ketamine/ dexmedetomidine combination versus dexmedetomidine alone for procedural sedation in cirrhotic patients undergoing UGIE regarding efficacy and safety.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Hatem Saber mohamed
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Address
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Qena university hospital-Qena- El-maabar street next to the faculty of nursing ,postal code 85823.
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Country
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Egypt
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Phone
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+201005257062
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Fax
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Email
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dr.hatem_saber@hotmail.com
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Contact person for public queries
Name
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Dr Gad sayed gad
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Address
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Qena university hospital-Qena-Elmaabar street next to the faculty of nursing ,postal code 85823.
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Country
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Egypt
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Phone
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+201099075675
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Fax
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Email
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alwafy35@yahoo.com
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Contact person for scientific queries
Name
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Dr Hatem saber mohamed
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Address
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Qena university hospital-Qena-Elmaabar street next to the faculty of nursing, postal code 85823.
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Country
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Egypt
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Phone
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+201005257062
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Fax
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Email
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dr.hatem_saber@hotmail.com
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No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
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Other publications
Have study results been made publicly available in another format?
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Results – basic reporting
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Results – plain English summary
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