Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000162819
Ethics application status
Approved
Date submitted
17/01/2012
Date registered
6/02/2012
Date last updated
6/02/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Using ketamine (an anesthetic agent) with Propofol (a hypnotic agent commonly used during sedation) during visual examination of large intestine reduces propofol dosage improves the quality of sedation
Scientific title
Propofol in combination with ketamin reduces propofol dosage and improves quality of sedation during colonoscopy: A prospective, randomized and double blind study
Secondary ID [1] 279731 0
Nil
Universal Trial Number (UTN)
U1111-1127-1936
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients undergoing colonoscopy under sedation 285576 0
Condition category
Condition code
Oral and Gastrointestinal 285770 285770 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Anaesthesiology 285771 285771 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients were randomized to 2 groups according to applied sedation protocol as follows.
Group 1: intravenous bolus saline was administred before propofol
Group 2: intravenous bolus 0.25 mg/kg ketamine was administered before propofol.
In each group propofol dosage was titrated according to patients sedation level. For both groups target sedation level was 1-2 with Modified Observer's assessment of Alertness/Sedation Scale.
Intervention code [1] 284030 0
Treatment: Drugs
Comparator / control treatment
Saline is used in propofol group
Control group
Placebo

Outcomes
Primary outcome [1] 286289 0
The amount of propofol used during sedation in each groups. Total propofol dosage used during all procedures will be recorded after the procedures are completed.
Timepoint [1] 286289 0
After the procedure
Primary outcome [2] 286290 0
Quality of Sedation
Assessed both by patients with questionniares and by the endoscopists.
Timepoint [2] 286290 0
Questionnaires were performed to patients before discharging and 24 hours after the procedure.
Endoscopist was asked to evaluate the quality of sedation at the end of the procedure between 0 and 10 (0: worst and 10:best)
Secondary outcome [1] 295534 0
Frequency of adverse events such as apnea, bradycardia, hypotension, nausea, vomiting, agitation, dreaming. The patients will be observed for the adverse events after the procedure until discharge. Therefore clinical assessment will be used.
Timepoint [1] 295534 0
During and after the procedure
Secondary outcome [2] 295535 0
Recovery time;
Time to spontaneous eye opening, time to discharge and aldrette scores.
The aldrete score is a score of 1 through 10 assessing a patient after anesthesia for discharge criteria. The Aldrete score assesses level of consciousness, respirtory status, circulatory status, activity and oxygen saturation
Timepoint [2] 295535 0
After the procedure
Aldrette scores were recorded at 2.5 minutes intervals after the procedure

Eligibility
Key inclusion criteria
ASA I-II patients undergoing colonoscopy under sedation
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Use of anti-anxiety medicine within 48 hours before the procedure, past history of anorectal, colonic and gynecologic surgery and complaint of pain at the anal area precluding examination

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)
Block randomization was used to keep the sample size of the groups similar. Random Allocation Software (Ver. 1.0.0) was used to allocate the patients to groups.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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
20/09/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 4053 0
Turkey
State/province [1] 4053 0

Funding & Sponsors
Funding source category [1] 284512 0
Hospital
Name [1] 284512 0
Mesa Hospital
Country [1] 284512 0
Turkey
Primary sponsor type
Individual
Name
Prof. Mehmet Ayhan KUZU
Address
Ankara University, Faculity of Medicine
Department of surgery 06100
Samanpazari, Ankara
Country
Turkey
Secondary sponsor category [1] 283442 0
None
Name [1] 283442 0
Address [1] 283442 0
Country [1] 283442 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286496 0
Ethics Commitee of Ankara University School of Medicine
Ethics committee address [1] 286496 0
Ethics committee country [1] 286496 0
Turkey
Date submitted for ethics approval [1] 286496 0
Approval date [1] 286496 0
15/10/2008
Ethics approval number [1] 286496 0
Ethics committee name [2] 286497 0
Ministry of Health of Turkey Ethics Commitee of General Directorate of Pharmaceuticals and Pharmacy
Ethics committee address [2] 286497 0
Ethics committee country [2] 286497 0
Turkey
Date submitted for ethics approval [2] 286497 0
Approval date [2] 286497 0
20/09/2010
Ethics approval number [2] 286497 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33634 0
Address 33634 0
Country 33634 0
Phone 33634 0
Fax 33634 0
Email 33634 0
Contact person for public queries
Name 16881 0
Hasan Kutluk Pampal
Address 16881 0
Gazi Universitesi Tip Fakültesi
Anesteziyoloji ve Reanimason AD
06500, Besevler, Ankara
Country 16881 0
Turkey
Phone 16881 0
+905325569624
Fax 16881 0
Email 16881 0
[email protected]
Contact person for scientific queries
Name 7809 0
Hasan Kutluk Pampal
Address 7809 0
Gazi Universitesi Tip Fakültesi
Anesteziyoloji ve Reanimason AD
06500, Besevler, Ankara
Country 7809 0
Turkey
Phone 7809 0
+905325569624
Fax 7809 0
Email 7809 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
No additional documents have been identified.