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The effect of bispectral index monitoring on early cognitive functions

The effect of bispectral index monitoring on early cognitive functions in patients undergoing sedation for colonoscopy: A prospective, randomized, controlled study

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12617000134325
Enrollment
100
Registered
2017-01-24
Start date
2017-01-30
Completion date
Unknown
Last updated
2017-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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, Aspec

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).

Sponsors

Konya Training and Research Hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

Patients between the ages of 18-70yr, ASA physical status I-III, scheduled to undergo planed colonoscopy, will be studied.

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 21, 2026