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

The Effect of Different Sedation Regimes Administered by Anesthesiologists or Endoscopists on Cognitive Functions in Lower Gastrointestinal System Endoscopy

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02486328
Enrollment
103
Registered
2015-07-01
Start date
2015-05-31
Completion date
2015-06-30
Last updated
2020-09-03

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

Conditions

Alteration of Cognitive Function, Gastrointestinal Dysfunction

Keywords

Cognitive dysfunction, Colonoscopy, Sedation

Brief summary

There are different sedation regimes for lower gastrointestinal system endoscopy which can be administered by anesthesiologists and non-anesthesiologists. This study aims to compare the effects of propofol/remifentanil combination and midazolam/meperidine combination on early cognitive function following lower gastrointestinal system endoscopies.

Detailed description

Sedation for lower gastrointestinal system endoscopies can be administered by anesthesiologists or endoscopists and cognitive dysfunction after this procedure has not been fully investigated. The aim of this study was to investigate the effect of different sedation regimes applied by anesthesiologists or endoscopists on early cognitive dysfunction. Following ethics committee approval and written informed consent, 100 patients were randomly divided into two groups. In Group MM where drug regime was solely determined by endoscopists, 2 mg midazolam and 20mg meperidine was given intravenously and additional 1-2mg midazolam and 20mg meperidine (wtih a maximum total of 5 mg midazolam and 50 mg meperidine) was given when facial pain scale (FPS) was greater than 3. In Group RP where drug regime was solely determined by anesthesiologists, 100 mcg/kg/min propofol infusion and 1 mcg/kg remifentanil bolus was administered and additional 0,5 mcg/kg remifentanil bolus was given when FPS was greater than 3. Bispectral index (BIS) and hemodynamic monitorization was carried out throughout the procedure and BIS 60-80 with FPS\<3 was targeted. The time to Observer Assessment of Alertness/Sedation Scale (OAAS) score to reach 3 was measured after the procedure and Trieger Dot Test (TDT) and Digit Symbol Substitution Test (DSST) was repeated at 5th, 15th and 30th minutes.

Interventions

DRUGMidazolam

Dosage adjustment

DRUGMeperidine

Dosage adjustment

DRUGRemifentanil

Dosage adjustment

DRUGPropofol

Dosage adjustment

Sponsors

Ufuk University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Patients between 18-65 years of age (ASA I-III risk groups), scheduled for elective colonoscopy

Exclusion criteria

* Patient refusal * Mini mental test (MMT) score\<26 * Amsterdam Preoperative Anxiety and Information Scale (APAIS ) score \>10 * Advanced cardiopulmonary or psychiatric disease * Chronic alcohol abuse * Morbid obesity * Known allergy to study drugs

Design outcomes

Primary

MeasureTime frameDescription
Change in Cognitive FunctionBaseline and 5, 15, 30 minutes after the procedureAs 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.

Secondary

MeasureTime frameDescription
Change in Visual Analogue Scale Scores From the BaselineBaseline and 5, 15, 30 minutes after the procedurePain as measured by Visual Analogue Scale. Range 1-10. No cut-off value, Higher results represent worse outcomes
Heart RateBaseline and 1,2,3,5,10,15 and 20 minutesHeart rate as measured in beats per minute
Mean Arterial PressureBaseline and 1,2,3,5,10,15 and 20 minutesmean arterial blood pressure as measured in mmHg
Peripheral Oxygen SaturationBaseline and 1,2,3,5,10,15 and 20 minutesperipheral oxygen saturation as measured by pulse oximeter. Units are percentages, Scale range 0-100.

Participant flow

Participants by arm

ArmCount
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 FPS greater than 3 Midazolam: Dosage adjustment Meperidine: Dosage adjustment
52
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
51
Total103

Baseline characteristics

CharacteristicGroup MMGroup RPTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
52 Participants51 Participants103 Participants
Age, Continuous57.1 years
STANDARD_DEVIATION 13.6
53.7 years
STANDARD_DEVIATION 10.4
55.6 years
STANDARD_DEVIATION 12.5
Mini Mental Test28.2 units on a scale
STANDARD_DEVIATION 1.3
28.6 units on a scale
STANDARD_DEVIATION 1.6
28.3 units on a scale
STANDARD_DEVIATION 1.4
Race/Ethnicity, Customized52 participants51 participants103 participants
Region of Enrollment
Turkey
52 participants51 participants103 participants
Sex: Female, Male
Female
21 Participants14 Participants35 Participants
Sex: Female, Male
Male
31 Participants37 Participants68 Participants
Weight71.7 kilograms
STANDARD_DEVIATION 11.7
73.1 kilograms
STANDARD_DEVIATION 15.5
72.4 kilograms
STANDARD_DEVIATION 13.8

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 500 / 50
serious
Total, serious adverse events
0 / 500 / 50

Outcome results

Primary

Change in Cognitive Function

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.

Time frame: Baseline and 5, 15, 30 minutes after the procedure

ArmMeasureGroupValue (MEAN)Dispersion
Group MMChange in Cognitive Function5th minute47.5 units on a scaleStandard Deviation 10.6
Group MMChange in Cognitive Function15th minute44.7 units on a scaleStandard Deviation 9.2
Group MMChange in Cognitive Function30th minute42 units on a scaleStandard Deviation 7.9
Group RPChange in Cognitive Function5th minute40.4 units on a scaleStandard Deviation 6.8
Group RPChange in Cognitive Function15th minute37.8 units on a scaleStandard Deviation 5.6
Group RPChange in Cognitive Function30th minute35.4 units on a scaleStandard Deviation 6
p-value: 0.001Wilcoxon (Mann-Whitney)
Primary

Change in Cognitive Function

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

Time frame: Baseline and 5, 15, 30 minutes after the procedure

ArmMeasureGroupValue (MEAN)Dispersion
Group MMChange in Cognitive Function5th minute1.6 units on a scaleStandard Deviation 1.2
Group MMChange in Cognitive Function15th minute2.1 units on a scaleStandard Deviation 1.4
Group MMChange in Cognitive Function30th minute2.4 units on a scaleStandard Deviation 1.4
Group RPChange in Cognitive Function5th minute2 units on a scaleStandard Deviation 1.6
Group RPChange in Cognitive Function15th minute2.8 units on a scaleStandard Deviation 1.8
Group RPChange in Cognitive Function30th minute3.5 units on a scaleStandard Deviation 2.1
p-value: 0.001Wilcoxon (Mann-Whitney)
Secondary

Change in Visual Analogue Scale Scores From the Baseline

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

Time frame: Baseline and 5, 15, 30 minutes after the procedure

ArmMeasureGroupValue (MEAN)Dispersion
Group MMChange in Visual Analogue Scale Scores From the Baseline5 minutes after the procedure0.9 units on a scaleStandard Deviation 2.1
Group MMChange in Visual Analogue Scale Scores From the Baseline15 minutes after the procedure0.5 units on a scaleStandard Deviation 1.2
Group MMChange in Visual Analogue Scale Scores From the Baseline30 minutes after the procedure0.1 units on a scaleStandard Deviation 0.3
Group RPChange in Visual Analogue Scale Scores From the Baseline5 minutes after the procedure0.4 units on a scaleStandard Deviation 1.1
Group RPChange in Visual Analogue Scale Scores From the Baseline15 minutes after the procedure0.4 units on a scaleStandard Deviation 1.1
Group RPChange in Visual Analogue Scale Scores From the Baseline30 minutes after the procedure0.1 units on a scaleStandard Deviation 0.7
p-value: 0.001Wilcoxon (Mann-Whitney)
Secondary

Heart Rate

Heart rate as measured in beats per minute

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

ArmMeasureGroupValue (MEAN)Dispersion
Group MMHeart Ratebaseline90.2 beats per minuteStandard Deviation 15.5
Group MMHeart Rate1 minute in procedure89.6 beats per minuteStandard Deviation 17.8
Group MMHeart Rate2 minute in procedure88 beats per minuteStandard Deviation 16.4
Group MMHeart Rate3 minute in procedure87.6 beats per minuteStandard Deviation 14.8
Group MMHeart Rate5 minute in procedure87.7 beats per minuteStandard Deviation 14.8
Group MMHeart Rate10 minute in procedure85.3 beats per minuteStandard Deviation 16.1
Group MMHeart Rate15 minute in procedure85.4 beats per minuteStandard Deviation 15
Group MMHeart Rate20 minute in procedure85 beats per minuteStandard Deviation 14.1
Group RPHeart Rate20 minute in procedure73.1 beats per minuteStandard Deviation 9.8
Group RPHeart Ratebaseline82.6 beats per minuteStandard Deviation 10
Group RPHeart Rate5 minute in procedure70.3 beats per minuteStandard Deviation 8.9
Group RPHeart Rate1 minute in procedure81.3 beats per minuteStandard Deviation 11.3
Group RPHeart Rate15 minute in procedure71.6 beats per minuteStandard Deviation 9.6
Group RPHeart Rate2 minute in procedure76 beats per minuteStandard Deviation 11.7
Group RPHeart Rate10 minute in procedure70 beats per minuteStandard Deviation 8.9
Group RPHeart Rate3 minute in procedure69.9 beats per minuteStandard Deviation 8.6
p-value: 0.001Kruskal-Wallis
Secondary

Mean Arterial Pressure

mean arterial blood pressure as measured in mmHg

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

ArmMeasureGroupValue (MEAN)Dispersion
Group MMMean Arterial Pressurebaseline105.7 mmHgStandard Deviation 19.5
Group MMMean Arterial Pressure1 minute in procedure103 mmHgStandard Deviation 16.7
Group MMMean Arterial Pressure2 minute in procedure104.5 mmHgStandard Deviation 16.2
Group MMMean Arterial Pressure3 minute in procedure105.8 mmHgStandard Deviation 17.7
Group MMMean Arterial Pressure5 minute in procedure101.5 mmHgStandard Deviation 20.4
Group MMMean Arterial Pressure10 minute in procedure103.8 mmHgStandard Deviation 16.6
Group MMMean Arterial Pressure15 minute in procedure102.4 mmHgStandard Deviation 17.2
Group MMMean Arterial Pressure20 minute in procedure99.3 mmHgStandard Deviation 18.7
Group RPMean Arterial Pressure20 minute in procedure94.3 mmHgStandard Deviation 15.8
Group RPMean Arterial Pressurebaseline113.1 mmHgStandard Deviation 13
Group RPMean Arterial Pressure5 minute in procedure87.1 mmHgStandard Deviation 14.3
Group RPMean Arterial Pressure1 minute in procedure104 mmHgStandard Deviation 14.4
Group RPMean Arterial Pressure15 minute in procedure91.6 mmHgStandard Deviation 18.5
Group RPMean Arterial Pressure2 minute in procedure92.9 mmHgStandard Deviation 11.9
Group RPMean Arterial Pressure10 minute in procedure100 mmHgStandard Deviation 15
Group RPMean Arterial Pressure3 minute in procedure89.3 mmHgStandard Deviation 15.9
p-value: 0.001Kruskal-Wallis
Secondary

Peripheral Oxygen Saturation

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

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

ArmMeasureGroupValue (MEAN)Dispersion
Group MMPeripheral Oxygen Saturationbaseline97.2 Percent of oxygenated hemoglobinStandard Deviation 1.9
Group MMPeripheral Oxygen Saturation1 minute in procedure97.2 Percent of oxygenated hemoglobinStandard Deviation 2
Group MMPeripheral Oxygen Saturation2 minute in procedure97.5 Percent of oxygenated hemoglobinStandard Deviation 1.7
Group MMPeripheral Oxygen Saturation3 minute in procedure97.6 Percent of oxygenated hemoglobinStandard Deviation 1.3
Group MMPeripheral Oxygen Saturation5 minute in procedure97.4 Percent of oxygenated hemoglobinStandard Deviation 1.6
Group MMPeripheral Oxygen Saturation10 minute in procedure97.2 Percent of oxygenated hemoglobinStandard Deviation 2.4
Group MMPeripheral Oxygen Saturation15 minute in procedure97.2 Percent of oxygenated hemoglobinStandard Deviation 1.6
Group MMPeripheral Oxygen Saturation20 minute in procedure97.4 Percent of oxygenated hemoglobinStandard Deviation 1.8
Group RPPeripheral Oxygen Saturation20 minute in procedure98.2 Percent of oxygenated hemoglobinStandard Deviation 2.2
Group RPPeripheral Oxygen Saturationbaseline98.6 Percent of oxygenated hemoglobinStandard Deviation 0.9
Group RPPeripheral Oxygen Saturation5 minute in procedure97.1 Percent of oxygenated hemoglobinStandard Deviation 4
Group RPPeripheral Oxygen Saturation1 minute in procedure98 Percent of oxygenated hemoglobinStandard Deviation 2.2
Group RPPeripheral Oxygen Saturation15 minute in procedure98.3 Percent of oxygenated hemoglobinStandard Deviation 1.1
Group RPPeripheral Oxygen Saturation2 minute in procedure98.5 Percent of oxygenated hemoglobinStandard Deviation 0.9
Group RPPeripheral Oxygen Saturation10 minute in procedure98.1 Percent of oxygenated hemoglobinStandard Deviation 1.3
Group RPPeripheral Oxygen Saturation3 minute in procedure98.4 Percent of oxygenated hemoglobinStandard Deviation 1.1
p-value: 0.001Kruskal-Wallis

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026