CompletedNot Applicable

Adequacy of Anaesthesia for Colonoscopic Procedures

Poland158 participantsStarted 2019-09-01

Plain-language 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.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

intraoperative pain perception: 11 points numeric rating scale

Timeframe: after 2 hours after emergence from sedation

postoperative pain perception: 11 points numeric rating scale

Timeframe: immediately after emergence form sedation

Trial details

NCT IDNCT03922815

SponsorMedical University of Silesia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-01-31

View on ClinicalTrials.gov More Colonic Diseases, Functional trials