Adequacy of Anaesthesia for Colonoscopic Procedures

NCT03922815 | Completed DMC

• 1 other identifier: SilesianMUKOAiIT12
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 1

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.

Conditions

Colonic Diseases, Functional

Keywords

Surgical Pleth Index (SPI); Adequacy of Anaesthesia (AoA); State Entropy (SE); Postoperative nausea and vomitting (PONV); Colonoscopy

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (2)

• patient's satisfaction: 4 points numeric rating scale

  2 hours after emergence from sedation

• operator's satisfaction: 4 points numeric scale

  immediately after the end of the procedure

Study Arms (3)

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

Drug: rescue fentanyl; Drug: rescue propofol

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%

Drug: rescue fentanyl; Drug: rescue propofol

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

Drug: rescue fentanyl; Drug: rescue propofol

Interventions

rescue fentanyl DRUG

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

Also known as: rescue analgesia

AoA-guided propofol-fentanyl deep sedation; SE-guided propofol-fentanyl deep sedation; haemodynamic parametres-guided deep sedation

rescue propofol DRUG

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

Also known as: rescue sedation

AoA-guided propofol-fentanyl deep sedation; SE-guided propofol-fentanyl deep sedation; haemodynamic parametres-guided deep sedation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of Silesia: lead

Study Sites (1)

Medical University of Silesia

Sosnowiec, Silesian Voivodeship, 41-200, Poland

Location

Related Publications (7)

• 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.

  PMID: 25032676 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.

  PMID: 23471754 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.

  PMID: 24012235 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.

  PMID: 24535604 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.

  PMID: 27583920 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.

  PMID: 30881077 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.

  PMID: 30059837 RESULT

MeSH Terms

Conditions

Colonic Diseases, Functional; Postoperative Nausea and Vomiting

Condition Hierarchy (Ancestors)

Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Study Officials

• Michał J Stasiowski, M.D

  Medical University of Silesia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Neither participant nor colonoscopic procedure provider are aware of the type of monitoring utilised during procedure.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2019
• First Posted: April 22, 2019
• Study Start: September 1, 2019
• Primary Completion: January 31, 2020
• Study Completion: January 31, 2020
• Last Updated: October 23, 2020

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: on a reasonable request

Locations

PL (1)