Trial Review

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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.
Scientific title
Safety and Efficacy of Ketamine-dexmedetomidine versus dexmedetomidine alone in cirrhotic patients undergoing upper gastrointestinal endoscopy.
Secondary ID [1] 285903 0
Nil
Universal Trial Number (UTN)
U 1111-1165-6212
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Procedural sedation during UGIE in cirrhotic patients 293820 0
Condition category
Condition code
Anaesthesiology 294123 294123 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 290879 0
Treatment: Drugs
Comparator / control treatment
The comparator/control treatment group is ketamine/dexmedetomidine group
Control group
Active

Outcomes
Primary outcome [1] 293925 0
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.
Timepoint [1] 293925 0
At termination of procedure.
Primary outcome [2] 294772 0
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.
Timepoint [2] 294772 0
Every 15 min in the first hour and thereafter every 30 min until hospital discharge of patient.
Secondary outcome [1] 312156 0
-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.
Timepoint [1] 312156 0
Every 2 min During the first 10 min of the procedure and thereafter every 5 min until termination of the procedure.

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 .
Minimum age
18 Years
Maximum age
60 Years
Gender
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/06/2014
Actual
7/06/2014
Date of last participant enrolment
Anticipated
2/12/2014
Actual
20/12/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
66
Accrual to date
Final
Recruitment outside Australia
Country [1] 6573 0
Egypt
State/province [1] 6573 0
Qena

Funding & Sponsors
Funding source category [1] 290484 0
University
Name [1] 290484 0
South valley university( SVU).
Address [1] 290484 0
SVU-Qena- postal code 85823
Country [1] 290484 0
Egypt
Primary sponsor type
University
Name
South valley university.
Address
SVU-Qena-postal code 85823
Country
Egypt
Secondary sponsor category [1] 289185 0
None
Name [1] 289185 0
Nil
Address [1] 289185 0
Nil
Country [1] 289185 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Ketamine/ dexmedetomidine combination versus dexmedetomidine alone for procedural sedation in cirrhotic patients undergoing UGIE regarding efficacy and safety.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 53738 0
Dr Hatem Saber mohamed
Address 53738 0
Qena university hospital-Qena- El-maabar street next to the faculty of nursing ,postal code 85823.
Country 53738 0
Egypt
Phone 53738 0
+201005257062
Fax 53738 0
Email 53738 0
dr.hatem_saber@hotmail.com
Contact person for public queries
Name 53739 0
Dr Gad sayed gad
Address 53739 0
Qena university hospital-Qena-Elmaabar street next to the faculty of nursing ,postal code 85823.
Country 53739 0
Egypt
Phone 53739 0
+201099075675
Fax 53739 0
Email 53739 0
alwafy35@yahoo.com
Contact person for scientific queries
Name 53740 0
Dr Hatem saber mohamed
Address 53740 0
Qena university hospital-Qena-Elmaabar street next to the faculty of nursing, postal code 85823.
Country 53740 0
Egypt
Phone 53740 0
+201005257062
Fax 53740 0
Email 53740 0
dr.hatem_saber@hotmail.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary