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

Gastrointestinal Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02486328
• Other study ID #: UfukU
• Status: Completed
• Phase: Phase 4
• Start date: May 2015
• Est. completion date: June 2015

Study information

• Verified date: August 2020
• Source: Ufuk University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Alteration of Cognitive Function
• Gastrointestinal Dysfunction

Intervention

Drug:
• Midazolam
Dosage adjustment
• Meperidine
Dosage adjustment
• Remifentanil
Dosage adjustment
• Propofol
Dosage adjustment

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ufuk University

References & Publications (3)

Cohen LB, Dubovsky AN, Aisenberg J, Miller KM. Propofol for endoscopic sedation: A protocol for safe and effective administration by the gastroenterologist. Gastrointest Endosc. 2003 Nov;58(5):725-32. — View Citation

Ferreira AO, Cravo M. Sedation in gastrointestinal endoscopy: Where are we at in 2014? World J Gastrointest Endosc. 2015 Feb 16;7(2):102-9. doi: 10.4253/wjge.v7.i2.102. Review. — View Citation

Padmanabhan U, Leslie K, Eer AS, Maruff P, Silbert BS. Early cognitive impairment after sedation for colonoscopy: the effect of adding midazolam and/or fentanyl to propofol. Anesth Analg. 2009 Nov;109(5):1448-55. doi: 10.1213/ane.0b013e3181a6ad31. Epub 20 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Baseline and 5, 15, 30 minutes after the procedure
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	Baseline and 5, 15, 30 minutes after the procedure
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	Baseline and 5, 15, 30 minutes after the procedure
Secondary	Heart Rate	Heart rate as measured in beats per minute	Baseline and 1,2,3,5,10,15 and 20 minutes
Secondary	Mean Arterial Pressure	mean arterial blood pressure as measured in mmHg	Baseline and 1,2,3,5,10,15 and 20 minutes
Secondary	Peripheral Oxygen Saturation	peripheral oxygen saturation as measured by pulse oximeter. Units are percentages, Scale range 0-100.	Baseline and 1,2,3,5,10,15 and 20 minutes