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

Brief Summary

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

Intervention / Treatment

  • Ketamine (DRUG)
    sedation drugs
  • Fentanyl (DRUG)
    sedation drugs
  • patient control analgesia (DEVICE)

Condition or Disease

  • Colonoscopy
  • Ketamine
  • Fentanyl

Phase

Study Design

Study type: OBSERVATIONAL
Status: Completed
Study results: No Results Available
Age: 18 Years to 75 Years
Enrollment: 120 (ACTUAL)
Funded by: Other
Time Perspective: Prospective
Observational Model: Cohort

Masking

Clinical Trial Dates

Start date: Mar 01, 2018 ACTUAL
Primary Completion: Jun 01, 2018 ACTUAL
Completion Date: Jun 01, 2018 ACTUAL
Study First Posted: Jul 31, 2018 ACTUAL
Results First Posted: Aug 31, 2020
Last Updated: Jul 23, 2018

Sponsors / Collaborators

Lead Sponsor: N/A
Responsible Party: N/A

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.

Participant Groups

  • ketamine used

  • fentanyl used

Eligibility Criteria

Sex: All
Minimum Age: 18
Maximum Age: 75
Age Groups: Adult / Older Adult
Healthy Volunteers: Yes

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

Primary Outcomes
  • Pain level assessed by VAS

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

Secondary Outcomes
  • duration of operation time will be asssessed as min.

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

More Details

NCT Number: NCT03607110
Other IDs: 2018/94
Study URL: https://clinicaltrials.gov/study/NCT03607110
Last updated: Sep 29, 2023