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Completed

NCT Number: NCT03922815

Adequacy of Anaesthesia for Colonoscopic Procedures

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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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of Silesia

Sosnowiec, Silesian Voivodeship, 41-200, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

rescue fentanyl

Drug

a rescue dose of fentanyl 0,5 mcg per kilogram of body

Other names: rescue analgesia

rescue propofol

Drug

propofol in a single dose of 0,5 mg/kg of body weight

Other names: rescue sedation

Primary outcomes

  1. intraoperative pain perception: 11 points numeric rating scale

    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)

  2. postoperative pain perception: 11 points numeric rating scale

    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)

Secondary outcomes

  1. patient's satisfaction: 4 points numeric rating scale

    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

  2. operator's satisfaction: 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

Sponsors and collaborators

Lead sponsor

Medical University of Silesia

Other

Registry information

Official study title

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

Acronym: AoAColon

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Apr 22, 2019
Registry last updated
Oct 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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