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Adequacy of Anaesthesia for Colonoscopic Procedures (AoAColon)

Primary Purpose

Colonic Diseases, Functional

Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
rescue fentanyl
rescue propofol
Sponsored by
Medical University of Silesia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Colonic Diseases, Functional focused on measuring Surgical Pleth Index (SPI), Adequacy of Anaesthesia (AoA), State Entropy (SE), Postoperative nausea and vomitting (PONV), Colonoscopy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Sites / Locations

  • Medical University of Silesia

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

haemodynamic parametres-guided deep sedation

SE-guided propofol-fentanyl deep sedation

AoA-guided propofol-fentanyl deep sedation

Arm Description

propofol 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

propofol 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%

propofol 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

Outcomes

Primary Outcome Measures

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)
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)

Secondary Outcome Measures

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
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

Full Information

First Posted
April 17, 2019
Last Updated
October 22, 2020
Sponsor
Medical University of Silesia
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1. Study Identification

Unique Protocol Identification Number
NCT03922815
Brief Title
Adequacy of Anaesthesia for Colonoscopic Procedures
Acronym
AoAColon
Official Title
Influence of Adequacy of Anaesthesia Monitoring on Both Operators' and Patients' Satisfaction in Patients Undergoing Colonoscopic Procedures
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
January 31, 2020 (Actual)
Study Completion Date
January 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of Silesia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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 colonoscopic procedures under intravenous sedation using propofol and fentanyl.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Diseases, Functional
Keywords
Surgical Pleth Index (SPI), Adequacy of Anaesthesia (AoA), State Entropy (SE), Postoperative nausea and vomitting (PONV), Colonoscopy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Masking Description
Neither participant nor colonoscopic procedure provider are aware of the type of monitoring utilised during procedure.
Allocation
Randomized
Enrollment
158 (Actual)

8. Arms, Groups, and Interventions

Arm Title
haemodynamic parametres-guided deep sedation
Arm Type
Experimental
Arm Description
propofol 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
Arm Title
SE-guided propofol-fentanyl deep sedation
Arm Type
Experimental
Arm Description
propofol 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%
Arm Title
AoA-guided propofol-fentanyl deep sedation
Arm Type
Experimental
Arm Description
propofol 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
Intervention Type
Drug
Intervention Name(s)
rescue fentanyl
Other Intervention Name(s)
rescue analgesia
Intervention Description
a rescue dose of fentanyl 0,5 mcg per kilogram of body
Intervention Type
Drug
Intervention Name(s)
rescue propofol
Other Intervention Name(s)
rescue sedation
Intervention Description
propofol in a single dose of 0,5 mg/kg of body weight
Primary Outcome Measure Information:
Title
intraoperative pain perception: 11 points numeric rating scale
Description
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)
Time Frame
after 2 hours after emergence from sedation
Title
postoperative pain perception: 11 points numeric rating scale
Description
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)
Time Frame
immediately after emergence form sedation
Secondary Outcome Measure Information:
Title
patient's satisfaction: 4 points numeric rating scale
Description
the patient will be asked if he/she was satisfied with sedation quality for the procedure of colonoscopy using 4 points numeric scale
Time Frame
2 hours after emergence from sedation
Title
operator's satisfaction: 4 points numeric scale
Description
the operator will be asked if he/she was satisfied with sedation quality for the procedure of colonoscopy using 4 points numeric scale
Time Frame
immediately after the end of the procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michał J Stasiowski, M.D
Organizational Affiliation
Medical University of Silesia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Silesia
City
Sosnowiec
State/Province
Silesia
ZIP/Postal Code
41-200
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
article in AiIT 2019
IPD Sharing Time Frame
on a reasonable request
Citations:
PubMed Identifier
25032676
Citation
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.
Results Reference
result
PubMed Identifier
23471754
Citation
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.
Results Reference
result
PubMed Identifier
24012235
Citation
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.
Results Reference
result
PubMed Identifier
24535604
Citation
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.
Results Reference
result
PubMed Identifier
27583920
Citation
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.
Results Reference
result
PubMed Identifier
30881077
Citation
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.
Results Reference
result
PubMed Identifier
30059837
Citation
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.
Results Reference
result

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Adequacy of Anaesthesia for Colonoscopic Procedures

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