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

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ClinicalTrials.gov Identifier: NCT03607110
Recruitment Status : Completed
First Posted : July 31, 2018
Last Update Posted : July 31, 2018
Sponsor:
Information provided by (Responsible Party):
Selda KAYAALTI, Develi Devlet Hastanesi

Tracking Information
First Submitted Date July 13, 2018
First Posted Date July 31, 2018
Last Update Posted Date July 31, 2018
Actual Study Start Date March 1, 2018
Actual Primary Completion Date June 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 23, 2018)
  • pain level - VAS SCALE [ Time Frame: during the operation ]
    Pain level assessed by VAS
  • 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)
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: July 23, 2018)
  • operation time [ Time Frame: during the operation ]
    duration of operation time will be asssessed as min.
  • side effects questionnaire [ Time Frame: during the operation ]
    Cardio pulmonary side effects (Hypotension, Bradycardia, Desaturation) and other side effects (Nausea and Vomiting, Headache)
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Comparison of Efficacy of Anesthesia Administered by Endoscopist or Anesthesiologist on Colonoscopy
Official Title Comparison of Ketamine-propofol Sedation Protocols With Fentanyl-propofol Administered by Endoscopist or Anesthesiologist at 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
Detailed Description 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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population colonoscopy patients with ASA I-II group
Condition
  • Colonoscopy
  • Ketamine
  • Fentanyl
Intervention
  • Drug: Ketamine
    sedation drugs
  • Drug: fentanyl
    sedation drugs
  • Device: patient control analgesia
    patient control analgesia
Study Groups/Cohorts
  • ketamine
    ketamine used
    Interventions:
    • Drug: Ketamine
    • Device: patient control analgesia
  • fentanyl
    fentanyl used
    Interventions:
    • Drug: fentanyl
    • Device: patient control analgesia
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 23, 2018)
120
Original Actual Enrollment Same as current
Actual Study Completion Date June 1, 2018
Actual Primary Completion Date June 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Turkey
Removed Location Countries  
 
Administrative Information
NCT Number NCT03607110
Other Study ID Numbers 2018/94
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement Not Provided
Responsible Party Selda KAYAALTI, Develi Devlet Hastanesi
Study Sponsor Selda KAYAALTI
Collaborators Not Provided
Investigators Not Provided
PRS Account Develi Devlet Hastanesi
Verification Date July 2018