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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]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Cognitive functions

Condition category

Condition code

Anaesthesiology

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]

Prevention

Intervention code [2]

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]

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]

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]

Total propofol dose

Timepoint [1]

Total propofol dose used during sedation will be recorded.

Secondary outcome [2]

Satisfaction of patients (Dissatisfied, neutral and satisfied).

Timepoint [2]

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?

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]

Turkey

State/province [1]

Konya

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Konya Training and Research Hospital

Address [1]

Konya Training and Research Hospital, Haci Saban Mah. Meram Yeniyol Caddesi No:97 Meram KONYA, Postcode:42090

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Necmettin Erbakan University Meram School of Medicine

Ethics committee address [1]

Necmettin Erbakan University Meram School of Medicine, Akyokus, Meram-Konya 42080

Ethics committee country [1]

Turkey

Date submitted for ethics approval [1]

27/11/2015

Approval date [1]

04/12/2015

Ethics approval number [1]

2015/366

Summary

Brief summary

In this study, we plan to evaluate whether there is any impact of BIS monitoring on early cognitive functions. To do this, we will apply to a group of BIS monitoring, while the other group will not implement BIS monitoring. We will perform tests to assess the cognitive functions of the patients after the procedure. We will compare the results of the same tests applied before the process.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Mehmet SARGIN

Address

Konya Training and Research Hospital, Anesthesiology and Reanimation Department, Haci Saban Mah. Meram Yeniyol Caddesi No:97 Post code: 42090 Meram KONYA

Country

Turkey

Phone

+905322662766

Fax

[email protected]

Contact person for public queries

Name

Mehmet SARGIN

Address

Konya Training and Research Hospital, Anesthesiology and Reanimation Department, Haci Saban Mah. Meram Yeniyol Caddesi No:97 Post code: 42090 Meram KONYA

Country

Turkey

Phone

+905322662766

Fax

[email protected]

Contact person for scientific queries

Name

Mehmet SARGIN

Address

Konya Training and Research Hospital, Anesthesiology and Reanimation Department, Haci Saban Mah. Meram Yeniyol Caddesi No:97 Post code: 42090 Meram KONYA

Country

Turkey

Phone

+905322662766

Fax

[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

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Study results article	Yes		Sao Paulo Med. J. [online]. 2019, vol.137, n.4, pp... [More Details]

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	The effect of bispectral index monitoring on cognitive performance following sedation for outpatient colonoscopy: A randomized controlled trial.	2019	https://dx.doi.org/10.1590/1516-3180.2018.0383210519

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically