NCT03922815

Adequacy of Anaesthesia for Colonoscopic Procedures

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 158 (actual)
• Sponsor: Medical University of Silesia · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colonic Diseases, Functional

Interventions

Type	Name	Description
DRUG	rescue fentanyl	a rescue dose of fentanyl 0,5 mcg per kilogram of body
DRUG	rescue propofol	propofol in a single dose of 0,5 mg/kg of body weight

Timeline

• Start date: 2019-09-01
• Primary completion: 2020-01-31
• Completion: 2020-01-31
• First posted: 2019-04-22
• Last updated: 2020-10-23

Locations

1 site across 1 country: Poland