Comparison of Efficacy of Anesthesia Administered by Endoscopist or Anesthesiologist on Colonoscopy

Study Overview
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Brief Summary
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In sedation applications performed by an endoscopist or anesthetist during colonoscopy, it was investigated whether there were differences in pain levels evaluated by VAS (Visuel analog scale), patient satisfaction, duration of procedure and side effects

Detailed Description
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Gastrointestinal endoscopes are an invasive and unpleasant procedure that is increasingly being performed worldwide (1). Colonoscopy; is one of the endoscopic procedures that can be used to diagnose and treat large intestine and cause pain and excessive discomfort in the patient (2). For this reason, intravenous (iv) sedative agents are used in endoscopy centers where endoscopy will be performed. However, side effects such as hypoxia and hypotension, which are usually dose-dependent, caused by these sedative agents, play an important role among risk factors associated with colonoscopy (3). For this reason, the use of propofol as an anesthetic is prohibited in some countries, which is a commonly used agent for sedation. However, the presence of an anesthetist during each endoscopy procedure is difficult because there are not enough anesthetists. This application is also more costly. For this reason, studies have been carried out during the gastrointestinal endoscopy when sedation is delivered by someone other than the anesthetist (4). For this purpose, several studies comparing patient-controlled sedation or sedation applied by an endoscopist to sedation performed by anesthesiologist were performed (4, 5). Investigators aimed to investigate whether there is any difference between the two groups in terms of pain levels assessed by VAS (Visuel analog scale) and patient satisfaction by comparing sedation protocols applied by endoscopist or anesthesist during colonoscopy in this study.

Official Title
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Comparison of Ketamine-propofol Sedation Protocols With Fentanyl-propofol Administered by Endoscopist or Anesthesiologist at Colonoscopy

Conditions
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Colonoscopy, Ketamine, Fentanyl

Intervention / Treatment
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* Drug: Ketamine
* Drug: fentanyl
* Device: patient control analgesia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who accept the method and will undergo elective colonoscopy ASA I-II group Patients with the ability to perform VAS scoring Exclusion Criteria: Patients who do not accept the method ASA III-IV-V group of patients with uncontrolled chronic disease (such as uncontrolled hypertension, uncontrolled diabetes mellitus) Patients with severe respiratory failure and cardiovascular disease Patients with liver and kidney failure Patients with long-term analgesic, opioid, sedative use history - Patients who are known to be hypersensitive to study medications, eggs, Those who are of pregnancy or pregnancy and those who are in breastfeeding period Those with antipsychotic or antidepressant medication usage

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

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ketamine<br>ketamine used | Drug: Ketamine<br>* sedation drugs<br>Device: patient control analgesia<br>* patient control analgesia<br>|
| fentanyl<br>fentanyl used | Drug: fentanyl<br>* sedation drugs<br>Device: patient control analgesia<br>* patient control analgesia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain level - VAS SCALE | Pain level assessed by VAS | during the operation | 
| patient satisfaction - Patient satisfaction Scale | patient satisfaction assessed by with satisfaction score of 4 points-scale (1 very good, 2 good, 3 not bad, 4 bad) | during the operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| operation time | duration of operation time will be asssessed as min. | during the operation | 
| side effects questionnaire | Cardio pulmonary side effects (Hypotension, Bradycardia, Desaturation) and other side effects (Nausea and Vomiting, Headache) | during the operation |