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Gastrointestinal DysfunctionPhase 4NCT02486328

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

A Phase 4 study testing Midazolam, Meperidine and Remifentanil in people with Gastrointestinal Dysfunction and Alteration of Cognitive Function, run by Ufuk University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Midazolam, Meperidine and Remifentanil
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
103 participants
Where
No sites listed yet
Study dates
May 2015to Jun 2015
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

About this study

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

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.

Read the 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.

Being tested
Midazolam, Meperidine, Remifentanil, Propofol
Keywords
Cognitive dysfunction, Colonoscopy, Sedation
Medical subject headings
Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MidazolamDrug

    Also called Versed

    Dosage adjustment

  • MeperidineDrug

    Also called Demerol

    Dosage adjustment

  • RemifentanilDrug

    Also called Ultiva

    Dosage adjustment

  • PropofolDrug

    Also called Diprivan

    Dosage adjustment

Study groups in NCT02486328
Study groupRoleWhat they receive
Group MMOther2 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
Receives: Drug: Midazolam; Drug: Meperidine
Group RPOther100 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
Receives: Drug: Remifentanil; Drug: Propofol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. Change in Cognitive Function

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

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

Secondary outcomes (4)

  1. 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

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

  2. Heart Rate

    Heart rate as measured in beats per minute

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

  3. Mean Arterial Pressure

    mean arterial blood pressure as measured in mmHg

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

  4. Peripheral Oxygen Saturation

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jul 2015 (estimated)
  2. Study startMay 2015
  3. Primary completionJun 2015
  4. Study completionJun 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
103 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02486328
Sponsor's protocol ID
UfukU
Status last verified
Aug 2020
First submitted
24 Jun 2015
Last updated
3 Sep 2020
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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. doi: 10.1016/s0016-5107(03)02010-8.

    PubMed 14595310

  • 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.

    PubMed 25685266

  • 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 2009 Jul 17.

    PubMed 19617584

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Midazolam, Meperidine and Remifentanil in people with Gastrointestinal Dysfunction and Alteration of Cognitive Function, run by Ufuk University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Cognitive Function (time frame: Baseline and 5, 15, 30 minutes after the procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02486328, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2020.

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