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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| haemodynamic parametres-guided deep sedation | Experimental | 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 |
|
| SE-guided propofol-fentanyl deep sedation | Experimental | 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% |
|
| AoA-guided propofol-fentanyl deep sedation | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rescue fentanyl | Drug | a rescue dose of fentanyl 0,5 mcg per kilogram of body |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | after 2 hours after emergence from sedation |
| 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) | immediately after emergence form sedation |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 2 hours after emergence from sedation |
| operator's satisfaction: 4 points numeric scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michał J Stasiowski, M.D | Medical University of Silesia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Silesia | Sosnowiec | Silesian Voivodeship | 41-200 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25032676 | Result | 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. | |
| 23471754 | Result | 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. |
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article in AiIT 2019
on a reasonable request
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| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D020250 | Postoperative Nausea and Vomiting |
| ID | Term |
|---|---|
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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Neither participant nor colonoscopic procedure provider are aware of the type of monitoring utilised during procedure.
|
| rescue propofol | Drug | propofol in a single dose of 0,5 mg/kg of body weight |
|
|
the operator will be asked if he/she was satisfied with sedation quality for the procedure of colonoscopy using 4 points numeric scale |
| immediately after the end of the procedure |
| 24012235 | Result | 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. |
| 24535604 | Result | 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. |
| 27583920 | Result | 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. |
| 30881077 | Result | 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. |
| 30059837 | Result | 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. |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009325 | Nausea |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D014839 | Vomiting |