Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000372583
Ethics application status
Approved
Date submitted
10/02/2015
Date registered
23/04/2015
Date last updated
23/04/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of adding ketamine infusion to propofol sedation on hemodynamic changes and recovery in patients undergoing elective lower limb surgery under spinal anaesthesia
Scientific title
Addition of ketamine infusion to propofol sedation with spinal anesthesia in patients undergoing elective lower limb surgery: Hemodynamic changes, Recovery Profile
Secondary ID [1] 286145 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
sedation for elective lower limb surgery 294155 0
Condition category
Condition code
Anaesthesiology 294481 294481 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intravenous infusions of propofol alone and ketamine combined with propofol during sedation. In group P: Propofol infusion dose is 25-75 mcg/kg/min and titrated according to Ramsey Sedation Score. In group KP: Propofol was managed like in Group P and ketamine dose is 1/3 of propofol in terms of mg.
Intervention code [1] 291152 0
Treatment: Drugs
Comparator / control treatment
In group P: Propofol infusion dose is 25-75 mcg/kg/min
Control group
Active

Outcomes
Primary outcome [1] 294261 0
To observe difference in terms of hemodymanic parameters which were heart rate with electrocardiogram, noninvasive systolic, diastolic, mean blood pressure, peripheral oxygen saturation with pulse oxymetry.
(composite outcome)
Timepoint [1] 294261 0
All measurements done every 5 minutes during surgery.
Primary outcome [2] 294262 0
Recovery profile assessed with mini mentel state examination
Timepoint [2] 294262 0
MMSE done first preoperatively and secondly thirty minutes after the sedation ending.
Secondary outcome [1] 312894 0
Side effects of ketamine infusion like agitation, vomiting, emergence reactions.
Timepoint [1] 312894 0
During sedation and in thirty minutes of the recovery period
Secondary outcome [2] 313796 0
Patient satisfaction were evaluated postoperatively
Timepoint [2] 313796 0
Postoperative questionnaire administered post-operatively on a three-point scale (1 = bad, 2 = borderline 3 = good)
Secondary outcome [3] 314122 0
Surgeon satisfaction were evaluated postoperatively
Timepoint [3] 314122 0
Postoperative questionnaire administered post-operatively on a three-point scale (1 = bad, 2 = borderline 3 = good)

Eligibility
Key inclusion criteria
25-80 years old
Both gender
Candidate of elective lower limb surgery
Do not have contraindications for spinal anesthesia
Minimum age
25 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with a allergic reaction to propofol or ketamine, obesity (BMI greater than or equal to 35)  , uncontrolled hypertension ( greater than 170/100mmHg), clinically significant cardiac, pulmonary, hepatic, renal dysfunction, psychiatric disorders, neurologic impairment were exluded from study.

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2014
Actual
7/07/2014
Date of last participant enrolment
Anticipated
6/10/2014
Actual
6/10/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
61
Accrual to date
Final
Recruitment outside Australia
Country [1] 6649 0
Turkey
State/province [1] 6649 0
Ankara

Funding & Sponsors
Funding source category [1] 290720 0
Self funded/Unfunded
Name [1] 290720 0
None
Country [1] 290720 0
Primary sponsor type
Individual
Name
Aysu Hayriye Tezcan
Address
Talatpasa Avenue, Ankara Numune Education and Research Hospital, Postcode: 06100, City: Ankara
Country
Turkey
Secondary sponsor category [1] 289408 0
None
Name [1] 289408 0
Address [1] 289408 0
Country [1] 289408 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292358 0
TC Saglik Bakanligi Ilac ve Tibbi Cihaz Kurumu Klinik Arastirmalar Baskanligi
Ethics committee address [1] 292358 0
TC SB Ilac ve Tibbi Cihaz Kurumu
Street No:2176 N: 5 Postcode: 06520
Sogutozu/Cankaya/ANKARA
Ethics committee country [1] 292358 0
Turkey
Date submitted for ethics approval [1] 292358 0
28/05/2014
Approval date [1] 292358 0
06/06/2014
Ethics approval number [1] 292358 0

Summary
Brief summary
We tried to evaluate the difference between two sedation drugs with the route of ; propofol alone intravenous infusion and ketamine-propofol combined intravenous infusion. We studied during lower limb surgery with spinal anesthesia. And observed patients hemodynamic values, mini mental state examination scores, postoperative events, satisfaction scores.
Trial website
Trial related presentations / publications
Not published or presented. Only submitted to European Journal of Anesthesia a few days ago and is under editor assessment.
Public notes

Contacts
Principal investigator
Name 54818 0
Dr Aysu Hayriye Tezcan
Address 54818 0
Talatpasa Avenue, Ankara Numune Education and Research Hospital, Postcode: 06100, City:Ankara
Country 54818 0
Turkey
Phone 54818 0
+90 5326735711
Fax 54818 0
Email 54818 0
[email protected]
Contact person for public queries
Name 54819 0
Dr Aysu Hayriye Tezcan
Address 54819 0
Talatpasa Avenue, Ankara Numune Education and Research Hospital, Postcode: 06100, City:Ankara
Country 54819 0
Turkey
Phone 54819 0
+90 5326735711
Fax 54819 0
Email 54819 0
[email protected]
Contact person for scientific queries
Name 54820 0
Dr Aysu Hayriye Tezcan
Address 54820 0
Talatpasa Avenue Ankara Numune Education and Research Hospital. Postcode: 06100, City:Ankara
Country 54820 0
Turkey
Phone 54820 0
+90 5326735711
Fax 54820 0
Email 54820 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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