Medical University of Silesia
Sosnowiec, Silesian Voivodeship, 41-200, Poland
NCT Number: NCT03922815
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.
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Notify Me18 year–75 year
All sexes
Interventional
Not applicable
Sosnowiec, Silesian Voivodeship, 41-200, Poland
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
a rescue dose of fentanyl 0,5 mcg per kilogram of body
Other names: rescue analgesia
propofol in a single dose of 0,5 mg/kg of body weight
Other names: rescue sedation
Time frame: after 2 hours after emergence from sedation
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: immediately after emergence form sedation
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: 2 hours after emergence from sedation
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: immediately after the end of the procedure
the operator will be asked if he/she was satisfied with sedation quality for the procedure of colonoscopy using 4 points numeric scale
Medical University of Silesia
Other
Influence of Adequacy of Anaesthesia Monitoring on Both Operators' and Patients' Satisfaction in Patients Undergoing Colonoscopic Procedures
Acronym: AoAColon
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