Adequacy of Anaesthesia for Colonoscopic Procedures

Medical University of Silesia158 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

DOUBLE

Enrollment

158

Conditions

Colonic Diseases, Functional

Interventions

rescue fentanylDRUG

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

rescue propofolDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

Medical University of Silesia

Sosnowiec, Silesian Voivodeship, Poland

Outcomes

Primary Outcomes

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)

Time frame: 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)

Time frame: immediately after emergence form sedation

Secondary Outcomes

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

Time frame: 2 hours after emergence from sedation

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

Time frame: immediately after the end of the procedure

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.