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Colonic Diseases, FunctionalAoAColonNCT03922815

Adequacy of Anaesthesia for Colonoscopic Procedures

A study testing rescue fentanyl and rescue propofol in people with Colonic Diseases, Functional, run by Medical University of Silesia at 1 site in Poland.

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

The aim of this randomized prospective trial is to assess the utility of Adequacy of Anaesthesia technique (Response Entropy and Surgical Pleth Index) for monitoring pain perception intraoperatively and its influence on postoperative pain perception, both patients' and operators' satisfaction in patients undergoing… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Colonic Diseases, Functional
What is being tested?
rescue fentanyl and rescue propofol
Could I receive a placebo?
No, everyone receives an active treatment
How many people
158 participants
Where
1 sitePoland
Study dates
1 Sep 2019to 31 Jan 2020
Phase
Interventional
Are there results?
None posted in the registry

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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • written consent to participate in the study
  • written consent to undergo deep sedation for colonoscopic procedure
  • general heath condition I-III of American Society of Anaesthesiology

Who cannot join

  • necessity of administration of vasoactive drugs influencing SPI monitoring
  • pregnancy
  • anatomical malformation that make monitoring using SE sensor impossible
  • general atherosclerosis, heart rhythm disturbances impairing SPI monitoring
  • chronic medication using opioid drugs leading to resistancy to opioids.

Trial locations and contacts

1 site in 1 country.

Poland1 site

  • Medical University of Silesia

    Sosnowiec, Silesian Voivodeship, 41-200

Other trials in Poland

About this study

Official title: Influence of Adequacy of Anaesthesia Monitoring on Both Operators' and Patients' Satisfaction in Patients Undergoing Colonoscopic Procedures

The aim of this randomized prospective trial is to assess the utility of Adequacy of Anaesthesia technique (Response Entropy and Surgical Pleth Index) for monitoring pain perception intraoperatively and its influence on postoperative pain perception, both patients' and operators' satisfaction in patients undergoing colonoscopic procedures under intravenous sedation using propofol and fentanyl.

Read the detailed description

Surgical Pleth Index (SPI) is reported to properly reflect nociception-antinociception balance in patients undergoing surgical procedures, where a value of 100 corresponds to a high stress level and a value of 0 to a low stress level; values near 50 or increase in value > delta 10 correspond to the stress level which is known to reflect requirement for rescue analgesia.

The applicability of SPI- guided deep sedation regimen in colonoscopic procedures has not been previously studied. Additionally, depth of sedation markedly influences the nociception-antinociception balance so its monitoring also proved useful in procedures performed under deep sedation.

Therefore, we aim to investigate if both SPI-guided fentanyl administration alongside with State Entropy guided propofol aministration (Adequacy of Anaesthesia monitoring) versus State Entropy guided propofol aministration alongside with fentanyl titration based on haemodynamic parametres versus fentanyl titration based on haemodynamic parametres only influence both patients' or operator's satisfaction from anaesthetic management.

Being tested
rescue fentanyl, rescue propofol
Keywords
Surgical Pleth Index (SPI), Adequacy of Anaesthesia (AoA), State Entropy (SE), Postoperative nausea and vomitting (PONV), Colonoscopy
Medical subject headings
Colonic Diseases, Functional, Postoperative Nausea and Vomiting

What participants receive

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

  • rescue fentanylDrug

    Also called rescue analgesia

    a rescue dose of fentanyl 0,5 mcg per kilogram of body

  • rescue propofolDrug

    Also called rescue sedation

    propofol in a single dose of 0,5 mg/kg of body weight

Study groups in NCT03922815
Study groupRoleWhat they receive
haemodynamic parametres-guided deep sedationExperimentalpropofol will be tirtrated in a single dose of 0,5 mg/kg of body weight to disappearance of cilliary reflex; in the case of heart rate and/or arterial blood pressure increase by 20% a rescue dose of fentanyl 0,5 mcg per kilogram of body weight will be administered
Receives: Drug: rescue fentanyl; Drug: rescue propofol
SE-guided propofol-fentanyl deep sedationExperimentalpropofol will be tirtrated in a single dose of 0,5 mg/kg of body weight to a target SE < 80 alongside with a rescue dose 0,5 mcg per kilogram of body weight of fentanyl in the case of heart rate and/or arterial blood pressure increase by 20%
Receives: Drug: rescue fentanyl; Drug: rescue propofol
AoA-guided propofol-fentanyl deep sedationExperimentalpropofol will be tirtrated in a single dose of 0,5 mg/kg of body weight to a target SE < 80 alongside with a rescue dose 0,5 mcg per kilogram of body weightof fentanyl in the case of increase of SPI value > delta 15
Receives: Drug: rescue fentanyl; Drug: rescue propofol

What is being measured

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

  1. intraoperative pain perception: 11 points numeric rating scale

    the patient will be asked if he/she had any reminiscence of pain perception during procedure of colonoscopy using 11 points numeric rating scale (0 - no pain, 10 - maximum pain)

    Measured: after 2 hours after emergence from sedation

  2. postoperative pain perception: 11 points numeric rating scale

    the patient will be asked if he/she had any pain perception after emergence from sedation after procedure of colonoscopy using 11 points numeric rating scale (0 - no pain, 10 - maximum pain)

    Measured: immediately after emergence form sedation

Secondary outcomes (2)

  1. patient's satisfaction: 4 points numeric rating scale

    the patient will be asked if he/she was satisfied with sedation quality for the procedure of colonoscopy using 4 points numeric scale

    Measured: 2 hours after emergence from sedation

  2. operator's satisfaction: 4 points numeric scale

    the operator will be asked if he/she was satisfied with sedation quality for the procedure of colonoscopy using 4 points numeric scale

    Measured: immediately after the end of the procedure

Timeline

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

  1. First posted22 Apr 2019
  2. Study start1 Sep 2019
  3. Primary completion31 Jan 2020
  4. Study completion31 Jan 2020

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 N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
158 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03922815
Sponsor's protocol ID
SilesianMUKOAiIT12
Acronym
AoAColon
Status last verified
Oct 2018
First submitted
17 Apr 2019
Last updated
23 Oct 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: article in AiIT 2019

Publications

  • Gruenewald M, Herz J, Schoenherr T, Thee C, Steinfath M, Bein B. Measurement of the nociceptive balance by Analgesia Nociception Index and Surgical Pleth Index during sevoflurane-remifentanil anesthesia. Minerva Anestesiol. 2015 May;81(5):480-9. Epub 2014 Jul 17.

    PubMed 25032676

  • Gruenewald M, Ilies C, Herz J, Schoenherr T, Fudickar A, Hocker J, Bein B. Influence of nociceptive stimulation on analgesia nociception index (ANI) during propofol-remifentanil anaesthesia. Br J Anaesth. 2013 Jun;110(6):1024-30. doi: 10.1093/bja/aet019. Epub 2013 Mar 6.

    PubMed 23471754

  • Gruenewald M, Ilies C. Monitoring the nociception-anti-nociception balance. Best Pract Res Clin Anaesthesiol. 2013 Jun;27(2):235-47. doi: 10.1016/j.bpa.2013.06.007.

    PubMed 24012235

  • Gruenewald M, Willms S, Broch O, Kott M, Steinfath M, Bein B. Sufentanil administration guided by surgical pleth index vs standard practice during sevoflurane anaesthesia: a randomized controlled pilot study. Br J Anaesth. 2014 May;112(5):898-905. doi: 10.1093/bja/aet485. Epub 2014 Feb 16.

    PubMed 24535604

  • Won YJ, Lim BG, Lee SH, Park S, Kim H, Lee IO, Kong MH. Comparison of relative oxycodone consumption in surgical pleth index-guided analgesia versus conventional analgesia during sevoflurane anesthesia: A randomized controlled trial. Medicine (Baltimore). 2016 Aug;95(35):e4743. doi: 10.1097/MD.0000000000004743.

    PubMed 27583920

  • Abu Baker F, Mari A, Aamarney K, Hakeem AR, Ovadia B, Kopelman Y. Propofol sedation in colonoscopy: from satisfied patients to improved quality indicators. Clin Exp Gastroenterol. 2019 Feb 26;12:105-110. doi: 10.2147/CEG.S186393. eCollection 2019.

    PubMed 30881077

  • Zhang W, Zhu Z, Zheng Y. Effect and safety of propofol for sedation during colonoscopy: A meta-analysis. J Clin Anesth. 2018 Dec;51:10-18. doi: 10.1016/j.jclinane.2018.07.005. Epub 2018 Jul 27.

    PubMed 30059837

Questions about this trial

What is this clinical trial studying?

A study testing rescue fentanyl and rescue propofol in people with Colonic Diseases, Functional, run by Medical University of Silesia at 1 site in Poland.

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 3 inclusion and 5 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 23 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

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.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

intraoperative pain perception: 11 points numeric rating scale (time frame: after 2 hours after emergence from sedation). 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 NCT03922815, which also lists 7 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 23 Oct 2020.

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