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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/20/2021.

Adequacy of Anaesthesia for Colonoscopic Procedures

Clinicaltrials.gov identifier NCT03922815

Recruitment Status Not yet recruiting

First Posted April 22, 2019

Last update posted August 9, 2019

Study Description

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.

  • Condition or Disease:Colonic Diseases, Functional
  • Intervention/Treatment: Drug: rescue fentanyl
    Drug: rescue propofol
  • Phase: N/A
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.

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 150 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Double (Participant, Care Provider)
  • Primary Purpose: Diagnostic
  • Official Title: Influence of Adequacy of Anaesthesia Monitoring on Both Operators' and Patients' Satisfaction in Patients Undergoing Colonoscopic Procedures
  • Estimated Study Start Date: September 2019
  • Estimated Primary Completion Date: October 2019
  • Estimated Study Completion Date: February 2020
Arms and interventions
Arm Intervention/treatment
Experimental: AoA-guided propofol-fentanyl deep sedation
propofol will be tirtrated in a single dose of 0,5 mg/kg of body weight to a target SE < 80 alongside with a rescue dose 0,5 mcg per kilogram of body weightof fentanyl in the case of increase of SPI value > delta 15
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
Experimental: SE-guided propofol-fentanyl deep sedation
propofol will be tirtrated in a single dose of 0,5 mg/kg of body weight to a target SE < 80 alongside with a rescue dose 0,5 mcg per kilogram of body weight of fentanyl in the case of heart rate and/or arterial blood pressure increase by 20%
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
Experimental: haemodynamic parametres-guided deep sedation
propofol will be tirtrated in a single dose of 0,5 mg/kg of body weight to disappearance of cilliary reflex; in the case of heart rate and/or arterial blood pressure increase by 20% a rescue dose of fentanyl 0,5 mcg per kilogram of body weight will be administered
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
Outcome Measures
  • Primary Outcome Measures: 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 Outcome Measures: 1. 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
  • 2. 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
Eligibility Criteria
  • Ages Eligible for Study: 18 to 75 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

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.

Contacts and Locations
Contacts

Contact: Michał J Stasiowski, M.D 32-3682331 ext 0048 mstasiowski.anest@gmail.com

Contact: Lech Krawczyk, Ph. Dr 32-3682341 ext 0048 lech.kraw@gmail.com

Locations

Poland, Silesia
Medical University of Silesia
Sosnowiec

Sponsors and Collaborators

Medical University of Silesia

Investigators

Principal Investigator: Michał J Stasiowski, M.D Medical University of Silesia

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