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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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

Condition or disease Intervention/treatment
Colonoscopy Ketamine Fentanyl Drug: Ketamine Drug: fentanyl Device: patient control analgesia

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.

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Study Type : Observational
Actual Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparison of Ketamine-propofol Sedation Protocols With Fentanyl-propofol Administered by Endoscopist or Anesthesiologist at Colonoscopy
Actual Study Start Date : March 1, 2018
Actual Primary Completion Date : June 1, 2018
Actual Study Completion Date : June 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

Group/Cohort Intervention/treatment
ketamine
ketamine used
Drug: Ketamine
sedation drugs

Device: patient control analgesia
patient control analgesia

fentanyl
fentanyl used
Drug: fentanyl
sedation drugs

Device: patient control analgesia
patient control analgesia




Primary Outcome Measures :
  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 Outcome Measures :
  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)



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
colonoscopy patients with ASA I-II group
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03607110


Locations
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Turkey
Develi Hatice Muammer Kocatürk Devlet Hastanesi
Develi, Kayseri, Turkey
Sponsors and Collaborators
Selda KAYAALTI
Publications:
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Responsible Party: Selda KAYAALTI, Anesthesia and Reanimation Specialist, Develi Devlet Hastanesi
ClinicalTrials.gov Identifier: NCT03607110    
Other Study ID Numbers: 2018/94
First Posted: July 31, 2018    Key Record Dates
Last Update Posted: July 31, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Fentanyl
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics
Adjuvants, Anesthesia