Adequacy of Anaesthesia for Colonoscopic Procedures

Study Overview
=================
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.

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

Conditions
-----------------
Colonic Diseases, Functional

Intervention / Treatment
-----------------
* Drug: rescue fentanyl
* Drug: rescue propofol


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: haemodynamic parametres-guided deep sedation<br>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<br>* a rescue dose of fentanyl 0,5 mcg per kilogram of body<br>* Other names: rescue analgesia;Drug: rescue propofol<br>* propofol in a single dose of 0,5 mg/kg of body weight<br>* Other names: rescue sedation;|
| Experimental: SE-guided propofol-fentanyl deep sedation<br>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<br>* a rescue dose of fentanyl 0,5 mcg per kilogram of body<br>* Other names: rescue analgesia;Drug: rescue propofol<br>* propofol in a single dose of 0,5 mg/kg of body weight<br>* Other names: rescue sedation;|
| Experimental: AoA-guided propofol-fentanyl deep sedation<br>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<br>* a rescue dose of fentanyl 0,5 mcg per kilogram of body<br>* Other names: rescue analgesia;Drug: rescue propofol<br>* propofol in a single dose of 0,5 mg/kg of body weight<br>* Other names: rescue sedation;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intraoperative pain perception: 11 points numeric rating scale | 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) | after 2 hours after emergence from sedation | 
| postoperative pain perception: 11 points numeric rating scale | 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) | immediately after emergence form sedation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patient's satisfaction: 4 points numeric rating scale | the patient will be asked if he/she was satisfied with sedation quality for the procedure of colonoscopy using 4 points numeric scale | 2 hours after emergence from sedation | 
| operator's satisfaction: 4 points numeric scale | the operator will be asked if he/she was satisfied with sedation quality for the procedure of colonoscopy using 4 points numeric scale | immediately after the end of the procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Surgical Pleth Index (SPI), Adequacy of Anaesthesia (AoA), State Entropy (SE), Postoperative nausea and vomitting (PONV), Colonoscopy