Adequacy of Anaesthesia for Colonoscopic Procedures (AoAColon)

Medical University of Silesia

Status: Completed

Conditions: Colonic Diseases, Functional

Treatments: Drug: rescue fentanyl; Drug: rescue propofol

Study type: Interventional

Funder types: Other

Identifiers

NCT03922815

SilesianMUKOAiIT12

Details and patient eligibility

About

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.

Full 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.

Enrollment: 158 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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158 participants in 3 patient groups

haemodynamic parametres-guided deep sedation

Experimental group

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

Treatment:

Drug: rescue propofol

Drug: rescue fentanyl

SE-guided propofol-fentanyl deep sedation

Experimental group

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%

Treatment:

Drug: rescue propofol

Drug: rescue fentanyl

AoA-guided propofol-fentanyl deep sedation

Experimental group

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

Treatment:

Drug: rescue propofol

Drug: rescue fentanyl