Colonic Diseases, Functional
Conditions
Keywords
Surgical Pleth Index (SPI), Adequacy of Anaesthesia (AoA), State Entropy (SE), Postoperative nausea and vomitting (PONV), Colonoscopy
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.
Detailed 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.
Interventions
DRUGrescue fentanyl
a rescue dose of fentanyl 0,5 mcg per kilogram of body
DRUGrescue propofol
propofol in a single dose of 0,5 mg/kg of body weight
Sponsors
Medical University of Silesia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Caregiver)
Masking description
Neither participant nor colonoscopic procedure provider are aware of the type of monitoring utilised during procedure.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| intraoperative pain perception: 11 points numeric rating scale | 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) |
| postoperative pain perception: 11 points numeric rating scale | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| patient's satisfaction: 4 points numeric rating scale | 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 |
| operator's satisfaction: 4 points numeric scale | 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 |
Countries
Poland
Outcome results
None listed