Trial Outcomes & Findings for The Effect of Different Sedation Regimes on Cognitive Function in Lower Gastrointestinal System Endoscopy (NCT NCT02486328)

Results Overview

As measured by Trieger Dot Test. The test does not have an upper limit; the time taken to complete the test is added to the number of dots missed by the patient and a result is obtained. The lowest score possible is 0. Higher values represent worse outcomes.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

103 participants

Primary outcome timeframe

Baseline and 5, 15, 30 minutes after the procedure

Results posted on

2020-09-03

Participant Flow

Participant milestones

Participant milestones
Measure	Group MM 2 mg midazolam and 20mg meperidine given intravenously and additional 1-2mg midazolam and 20mg meperidine (wtih a maximum total of 5 mg midazolam and 50 mg meperidine) given when facial pain scale (FPS) greater than 3 Midazolam: Dosage adjustment Meperidine: Dosage adjustment	Group RP 100 mcg/kg/min propofol infusion and 1 mcg/kg remifentanil bolus administered and additional 0,5 mcg/kg remifentanil bolus given when FPS greater than 3 Remifentanil: Dosage adjustment Propofol: Dosage adjustment
Overall Study STARTED	52	51
Overall Study COMPLETED	50	50
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Effect of Different Sedation Regimes on Cognitive Function in Lower Gastrointestinal System Endoscopy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group MM n=52 Participants 2 mg midazolam and 20mg meperidine given intravenously and additional 1-2mg midazolam and 20mg meperidine (wtih a maximum total of 5 mg midazolam and 50 mg meperidine) given when FPS greater than 3 Midazolam: Dosage adjustment Meperidine: Dosage adjustment	Group RP n=51 Participants 100 mcg/kg/min propofol infusion and 1 mcg/kg remifentanil bolus administered and additional 0,5 mcg/kg remifentanil bolus given when FPS greater than 3 Remifentanil: Dosage adjustment Propofol: Dosage adjustment	Total n=103 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	52 Participants n=5 Participants	51 Participants n=7 Participants	103 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	57.1 years STANDARD_DEVIATION 13.6 • n=5 Participants	53.7 years STANDARD_DEVIATION 10.4 • n=7 Participants	55.6 years STANDARD_DEVIATION 12.5 • n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants	14 Participants n=7 Participants	35 Participants n=5 Participants
Sex: Female, Male Male	31 Participants n=5 Participants	37 Participants n=7 Participants	68 Participants n=5 Participants
Race/Ethnicity, Customized	52 participants n=5 Participants	51 participants n=7 Participants	103 participants n=5 Participants
Region of Enrollment Turkey	52 participants n=5 Participants	51 participants n=7 Participants	103 participants n=5 Participants
Weight	71.7 kilograms STANDARD_DEVIATION 11.7 • n=5 Participants	73.1 kilograms STANDARD_DEVIATION 15.5 • n=7 Participants	72.4 kilograms STANDARD_DEVIATION 13.8 • n=5 Participants
Mini Mental Test	28.2 units on a scale STANDARD_DEVIATION 1.3 • n=5 Participants	28.6 units on a scale STANDARD_DEVIATION 1.6 • n=7 Participants	28.3 units on a scale STANDARD_DEVIATION 1.4 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 5, 15, 30 minutes after the procedure

As measured by Trieger Dot Test. The test does not have an upper limit; the time taken to complete the test is added to the number of dots missed by the patient and a result is obtained. The lowest score possible is 0. Higher values represent worse outcomes.

Outcome measures

Outcome measures
Measure	Group MM n=50 Participants 2 mg midazolam and 20mg meperidine given intravenously and additional 1-2mg midazolam and 20mg meperidine (wtih a maximum total of 5 mg midazolam and 50 mg meperidine) given when FPS greater than 3 Midazolam: Dosage adjustment Meperidine: Dosage adjustment	Group RP n=50 Participants 100 mcg/kg/min propofol infusion and 1 mcg/kg remifentanil bolus administered and additional 0,5 mcg/kg remifentanil bolus given when FPS greater than 3 Remifentanil: Dosage adjustment Propofol: Dosage adjustment
Change in Cognitive Function 5th minute	47.5 units on a scale Standard Deviation 10.6	40.4 units on a scale Standard Deviation 6.8
Change in Cognitive Function 15th minute	44.7 units on a scale Standard Deviation 9.2	37.8 units on a scale Standard Deviation 5.6
Change in Cognitive Function 30th minute	42 units on a scale Standard Deviation 7.9	35.4 units on a scale Standard Deviation 6

PRIMARY outcome

Timeframe: Baseline and 5, 15, 30 minutes after the procedure

As measured by Digit Symbol Substitution Test. Scale range 0-9. No cut-off value. Higher results represent better outcomes

Outcome measures

Outcome measures
Measure	Group MM n=50 Participants 2 mg midazolam and 20mg meperidine given intravenously and additional 1-2mg midazolam and 20mg meperidine (wtih a maximum total of 5 mg midazolam and 50 mg meperidine) given when FPS greater than 3 Midazolam: Dosage adjustment Meperidine: Dosage adjustment	Group RP n=50 Participants 100 mcg/kg/min propofol infusion and 1 mcg/kg remifentanil bolus administered and additional 0,5 mcg/kg remifentanil bolus given when FPS greater than 3 Remifentanil: Dosage adjustment Propofol: Dosage adjustment
Change in Cognitive Function 5th minute	1.6 units on a scale Standard Deviation 1.2	2 units on a scale Standard Deviation 1.6
Change in Cognitive Function 15th minute	2.1 units on a scale Standard Deviation 1.4	2.8 units on a scale Standard Deviation 1.8
Change in Cognitive Function 30th minute	2.4 units on a scale Standard Deviation 1.4	3.5 units on a scale Standard Deviation 2.1

SECONDARY outcome

Timeframe: Baseline and 5, 15, 30 minutes after the procedure

Pain as measured by Visual Analogue Scale. Range 1-10. No cut-off value, Higher results represent worse outcomes

Outcome measures

Outcome measures
Measure	Group MM n=50 Participants 2 mg midazolam and 20mg meperidine given intravenously and additional 1-2mg midazolam and 20mg meperidine (wtih a maximum total of 5 mg midazolam and 50 mg meperidine) given when FPS greater than 3 Midazolam: Dosage adjustment Meperidine: Dosage adjustment	Group RP n=50 Participants 100 mcg/kg/min propofol infusion and 1 mcg/kg remifentanil bolus administered and additional 0,5 mcg/kg remifentanil bolus given when FPS greater than 3 Remifentanil: Dosage adjustment Propofol: Dosage adjustment
Change in Visual Analogue Scale Scores From the Baseline 5 minutes after the procedure	0.9 units on a scale Standard Deviation 2.1	0.4 units on a scale Standard Deviation 1.1
Change in Visual Analogue Scale Scores From the Baseline 15 minutes after the procedure	0.5 units on a scale Standard Deviation 1.2	0.4 units on a scale Standard Deviation 1.1
Change in Visual Analogue Scale Scores From the Baseline 30 minutes after the procedure	0.1 units on a scale Standard Deviation 0.3	0.1 units on a scale Standard Deviation 0.7

SECONDARY outcome

Timeframe: Baseline and 1,2,3,5,10,15 and 20 minutes

Heart rate as measured in beats per minute

Outcome measures

Outcome measures
Measure	Group MM n=50 Participants 2 mg midazolam and 20mg meperidine given intravenously and additional 1-2mg midazolam and 20mg meperidine (wtih a maximum total of 5 mg midazolam and 50 mg meperidine) given when FPS greater than 3 Midazolam: Dosage adjustment Meperidine: Dosage adjustment	Group RP n=50 Participants 100 mcg/kg/min propofol infusion and 1 mcg/kg remifentanil bolus administered and additional 0,5 mcg/kg remifentanil bolus given when FPS greater than 3 Remifentanil: Dosage adjustment Propofol: Dosage adjustment
Heart Rate baseline	90.2 beats per minute Standard Deviation 15.5	82.6 beats per minute Standard Deviation 10
Heart Rate 1 minute in procedure	89.6 beats per minute Standard Deviation 17.8	81.3 beats per minute Standard Deviation 11.3
Heart Rate 2 minute in procedure	88 beats per minute Standard Deviation 16.4	76 beats per minute Standard Deviation 11.7
Heart Rate 3 minute in procedure	87.6 beats per minute Standard Deviation 14.8	69.9 beats per minute Standard Deviation 8.6
Heart Rate 5 minute in procedure	87.7 beats per minute Standard Deviation 14.8	70.3 beats per minute Standard Deviation 8.9
Heart Rate 10 minute in procedure	85.3 beats per minute Standard Deviation 16.1	70 beats per minute Standard Deviation 8.9
Heart Rate 15 minute in procedure	85.4 beats per minute Standard Deviation 15	71.6 beats per minute Standard Deviation 9.6
Heart Rate 20 minute in procedure	85 beats per minute Standard Deviation 14.1	73.1 beats per minute Standard Deviation 9.8

SECONDARY outcome

Timeframe: Baseline and 1,2,3,5,10,15 and 20 minutes

mean arterial blood pressure as measured in mmHg

Outcome measures

Outcome measures
Measure	Group MM n=50 Participants 2 mg midazolam and 20mg meperidine given intravenously and additional 1-2mg midazolam and 20mg meperidine (wtih a maximum total of 5 mg midazolam and 50 mg meperidine) given when FPS greater than 3 Midazolam: Dosage adjustment Meperidine: Dosage adjustment	Group RP n=50 Participants 100 mcg/kg/min propofol infusion and 1 mcg/kg remifentanil bolus administered and additional 0,5 mcg/kg remifentanil bolus given when FPS greater than 3 Remifentanil: Dosage adjustment Propofol: Dosage adjustment
Mean Arterial Pressure baseline	105.7 mmHg Standard Deviation 19.5	113.1 mmHg Standard Deviation 13
Mean Arterial Pressure 1 minute in procedure	103 mmHg Standard Deviation 16.7	104 mmHg Standard Deviation 14.4
Mean Arterial Pressure 2 minute in procedure	104.5 mmHg Standard Deviation 16.2	92.9 mmHg Standard Deviation 11.9
Mean Arterial Pressure 3 minute in procedure	105.8 mmHg Standard Deviation 17.7	89.3 mmHg Standard Deviation 15.9
Mean Arterial Pressure 5 minute in procedure	101.5 mmHg Standard Deviation 20.4	87.1 mmHg Standard Deviation 14.3
Mean Arterial Pressure 10 minute in procedure	103.8 mmHg Standard Deviation 16.6	100 mmHg Standard Deviation 15
Mean Arterial Pressure 15 minute in procedure	102.4 mmHg Standard Deviation 17.2	91.6 mmHg Standard Deviation 18.5
Mean Arterial Pressure 20 minute in procedure	99.3 mmHg Standard Deviation 18.7	94.3 mmHg Standard Deviation 15.8

SECONDARY outcome

Timeframe: Baseline and 1,2,3,5,10,15 and 20 minutes

peripheral oxygen saturation as measured by pulse oximeter. Units are percentages, Scale range 0-100.

Outcome measures

Outcome measures
Measure	Group MM n=50 Participants 2 mg midazolam and 20mg meperidine given intravenously and additional 1-2mg midazolam and 20mg meperidine (wtih a maximum total of 5 mg midazolam and 50 mg meperidine) given when FPS greater than 3 Midazolam: Dosage adjustment Meperidine: Dosage adjustment	Group RP n=50 Participants 100 mcg/kg/min propofol infusion and 1 mcg/kg remifentanil bolus administered and additional 0,5 mcg/kg remifentanil bolus given when FPS greater than 3 Remifentanil: Dosage adjustment Propofol: Dosage adjustment
Peripheral Oxygen Saturation baseline	97.2 Percent of oxygenated hemoglobin Standard Deviation 1.9	98.6 Percent of oxygenated hemoglobin Standard Deviation 0.9
Peripheral Oxygen Saturation 1 minute in procedure	97.2 Percent of oxygenated hemoglobin Standard Deviation 2	98 Percent of oxygenated hemoglobin Standard Deviation 2.2
Peripheral Oxygen Saturation 2 minute in procedure	97.5 Percent of oxygenated hemoglobin Standard Deviation 1.7	98.5 Percent of oxygenated hemoglobin Standard Deviation 0.9
Peripheral Oxygen Saturation 3 minute in procedure	97.6 Percent of oxygenated hemoglobin Standard Deviation 1.3	98.4 Percent of oxygenated hemoglobin Standard Deviation 1.1
Peripheral Oxygen Saturation 5 minute in procedure	97.4 Percent of oxygenated hemoglobin Standard Deviation 1.6	97.1 Percent of oxygenated hemoglobin Standard Deviation 4
Peripheral Oxygen Saturation 10 minute in procedure	97.2 Percent of oxygenated hemoglobin Standard Deviation 2.4	98.1 Percent of oxygenated hemoglobin Standard Deviation 1.3
Peripheral Oxygen Saturation 15 minute in procedure	97.2 Percent of oxygenated hemoglobin Standard Deviation 1.6	98.3 Percent of oxygenated hemoglobin Standard Deviation 1.1
Peripheral Oxygen Saturation 20 minute in procedure	97.4 Percent of oxygenated hemoglobin Standard Deviation 1.8	98.2 Percent of oxygenated hemoglobin Standard Deviation 2.2

Adverse Events

Group MM

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group RP

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Perihan Ekmekçi

Ufuk University Faculty of Medicine

Phone: +903122044000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place