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Completed

NCT Number: NCT03607110

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

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

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Develi Hatice Muammer Kocatürk Devlet Hastanesi

Develi, Kayseri, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

ketamine

Drug

sedation drugs

Fentanyl

Drug

sedation drugs

patient control analgesia

Device

patient control analgesia

Primary outcomes

  1. pain level - VAS SCALE

    Time frame: during the operation

    Pain level assessed by VAS

  2. patient satisfaction - Patient satisfaction Scale

    Time frame: during the operation

    patient satisfaction assessed by with satisfaction score of 4 points-scale (1 very good, 2 good, 3 not bad, 4 bad)

Secondary outcomes

  1. operation time

    Time frame: during the operation

    duration of operation time will be asssessed as min.

  2. side effects questionnaire

    Time frame: during the operation

    Cardio pulmonary side effects (Hypotension, Bradycardia, Desaturation) and other side effects (Nausea and Vomiting, Headache)

Sponsors and collaborators

Lead sponsor

Selda KAYAALTI

Other Gov

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jul 31, 2018
Registry last updated
Jul 31, 2018

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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