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Trial registered on ANZCTR


Registration number
ACTRN12617000134325
Ethics application status
Approved
Date submitted
25/12/2016
Date registered
24/01/2017
Date last updated
24/01/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of bispectral index monitoring on early cognitive functions
Scientific title
The effect of bispectral index monitoring on early cognitive functions in patients undergoing sedation for colonoscopy: A prospective, randomized, controlled study
Secondary ID [1] 290806 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cognitive functions 301458 0
Condition category
Condition code
Anaesthesiology 301180 301180 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
One hundred patients between the ages of 18-70yr, ASA physical status I-III, scheduled to undergo planed colonoscopy, will be studied. Fasting periods will be in accordance with ASA guidelines. All patients will be instructed to colonoscopy preparation is applied as a standard in the endoscopy unit.
One hundred patients will be randomized, by using a computer-generated block randomisation, into 2 groups. In Group 1 (n=50), the depth of anesthesia will be monitored by the BIS (BIS Monitor, Aspect 2000TM XP, USA) and BIS scores will be maintained between 60-80. In Group 2 (n=50), BIS monitoring will not be performed.
To determine the baseline levels of cognitive functions of patients, mini-mental state examination (MMSE), the Trieger dot test (TDT) and clock drawing test (CDT) will be performed on the day of the procedure after admission to the endoscopy unit.
A 20-gauge IV catheter will be inserted in the right forearm when the patient arrived in the endoscopy room. Supplemental oxygen (4 l.min-1) will be administered through a nasal canul. In addition to routine monitoring (consisting of a pulse oximeter, 3-lead ECG and a non-invasive blood pressure cuff) BIS monitoring (BIS Monitor, Aspect 2000TM XP, USA) will be applied to the Group I patients. After baseline measurements (haemodynamic profiles and BIS values) will be obtained, the patient will be placed in the left lateral position.
Two milligram of midazolam will be administered intravenously. Next, an initial intravenous dose of propofol (0.3–0.5 mg/kg of body weight) will be administered, followed by repeated 10–20 mg doses so as to BIS values 60-80 or the patient expressed discomfort in Group I and the the patient’s sedation level was more than MOAA/S 4 or the patient expressed discomfort in Group II. Other medications, including analgesics, will not be used in the present study. All sedation procedures will be practised by an anesthesiologis who will be blind to pre-procedure. Colonoscopy will be commenced when the anesthesiologist decided that the depth of sedation was adequate.
When the patients will be classified as ready for hospital discharge according to Chung criteria (The total score is 10 and with patients scoring =>9 considered fit for discharge home), patient satisfaction will be evaluated (Dissatisfied, neutral and satisfied) and determined the post-procedural levels of cognitive functions of patients with mini-mental state examination (MMSE), the Trieger dot test (TDT) and clock drawing test (CDT).
Age, gender, ASA physical status, BMI, total propofol dose, sedation time, satisfaction of patients, MOAA/S arrival to PACU will be recorded. And also heart rate (HR), mean blood pressure (MBP), oxygen saturation (SpO2) and BIS values will be recorded. We will also record any complications associated with sedation (i.e. oxygen saturation < 90 %, blood pressure < 90/50 mm Hg, heart rate < 50 bpm).
Intervention code [1] 296729 0
Prevention
Intervention code [2] 296730 0
Early detection / Screening
Comparator / control treatment
Control group is Group II (BIS monitoring will not be use for this group)
Control group
Active

Outcomes
Primary outcome [1] 300597 0
Post-procedural cognitive functions evaluating with mini-mental state examination (MMSE), the Trieger dot test (TDT) and clock drawing test (CDT).
These are (MMSE, TDT, CDT) composite primary outcomes.
Timepoint [1] 300597 0
When the patients will be classified as ready for hospital discharge according to Chung criteria (The total score is 10 and with patients scoring =>9 considered fit for discharge home), post-procedural cognitive functions will be evaluated.
Secondary outcome [1] 330386 0
Total propofol dose
Timepoint [1] 330386 0
Total propofol dose used during sedation will be recorded.
Secondary outcome [2] 330387 0
Satisfaction of patients (Dissatisfied, neutral and satisfied).
Timepoint [2] 330387 0
When the patients will be classified as ready for hospital discharge according to Chung criteria (The total score is 10 and with patients scoring =>9 considered fit for discharge home), patient satisfaction will be evaluated (Dissatisfied, neutral and satisfied).

Eligibility
Key inclusion criteria
Patients between the ages of 18-70yr, ASA physical status I-III, scheduled to undergo planed colonoscopy, will be studied.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with inadequate Turkish comprehension, mini mental state examination score =< 23, significant cardio-respiratory instability (ASA IV–V), prior IV fluid administration, allergies to eggs, beans, or latex, those with a previous history of alcohol or sedative overdose, or of adverse events associated with propofol, and those with sleep apnea or with a recent history of central nervous system (CNS) abnormalities (e.g., stroke) will be excluded. And also patients who refused sedation during colonoscopy, who were hospitalized, or who were pregnant or lactating will exclude from the study.

Study design
Purpose of the study
Prevention
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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/01/2017
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] 8528 0
Turkey
State/province [1] 8528 0
Konya

Funding & Sponsors
Funding source category [1] 295233 0
Hospital
Name [1] 295233 0
Konya Training and Research Hospital
Country [1] 295233 0
Turkey
Primary sponsor type
Hospital
Name
Konya Training and Research Hospital
Address
Konya Training and Research Hospital, Haci Saban Mah. Meram Yeniyol Caddesi No:97 Meram KONYA, Postcode:42090
Country
Turkey
Secondary sponsor category [1] 294061 0
None
Name [1] 294061 0
Address [1] 294061 0
Country [1] 294061 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296575 0
Necmettin Erbakan University Meram School of Medicine
Ethics committee address [1] 296575 0
Ethics committee country [1] 296575 0
Turkey
Date submitted for ethics approval [1] 296575 0
27/11/2015
Approval date [1] 296575 0
04/12/2015
Ethics approval number [1] 296575 0
2015/366

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

Contacts
Principal investigator
Name 71342 0
Dr Mehmet SARGIN
Address 71342 0
Konya Training and Research Hospital, Anesthesiology and Reanimation Department, Haci Saban Mah. Meram Yeniyol Caddesi No:97 Post code: 42090 Meram KONYA
Country 71342 0
Turkey
Phone 71342 0
+905322662766
Fax 71342 0
Email 71342 0
[email protected]
Contact person for public queries
Name 71343 0
Mehmet SARGIN
Address 71343 0
Konya Training and Research Hospital, Anesthesiology and Reanimation Department, Haci Saban Mah. Meram Yeniyol Caddesi No:97 Post code: 42090 Meram KONYA
Country 71343 0
Turkey
Phone 71343 0
+905322662766
Fax 71343 0
Email 71343 0
[email protected]
Contact person for scientific queries
Name 71344 0
Mehmet SARGIN
Address 71344 0
Konya Training and Research Hospital, Anesthesiology and Reanimation Department, Haci Saban Mah. Meram Yeniyol Caddesi No:97 Post code: 42090 Meram KONYA
Country 71344 0
Turkey
Phone 71344 0
+905322662766
Fax 71344 0
Email 71344 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
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Sao Paulo Med. J. [online]. 2019, vol.137, n.4, pp... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe effect of bispectral index monitoring on cognitive performance following sedation for outpatient colonoscopy: A randomized controlled trial.2019https://dx.doi.org/10.1590/1516-3180.2018.0383210519
N.B. These documents automatically identified may not have been verified by the study sponsor.