Adequacy of Anaesthesia for Colonoscopic Procedures

Colonic Diseases, Functional Clinical Trial

— AoAColon  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03922815
• Other study ID #: SilesianMUKOAiIT12
• Status: Completed
• Phase: N/A
• Start date: September 1, 2019
• Est. completion date: January 31, 2020

Study information

• Verified date: October 2018
• Source: Medical University of Silesia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 colonoscopic procedures under intravenous sedation using propofol and fentanyl.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 158
• Est. completion date: January 31, 2020
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colonic Diseases
• Colonic Diseases, Functional

Intervention

Drug:
• rescue fentanyl
a rescue dose of fentanyl 0,5 mcg per kilogram of body
• rescue propofol
propofol in a single dose of 0,5 mg/kg of body weight

Locations

Country	Name	City	State
Poland	Medical University of Silesia	Sosnowiec	Silesia

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Silesia

Country where clinical trial is conducted

Poland, 

References & Publications (7)

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. — View 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 — View Citation

Gruenewald M, Ilies C, Herz J, Schoenherr T, Fudickar A, Höcker 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. — View 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. Review. — View 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 — View 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). — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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	immediately after the end of the procedure