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

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

Study Overview

• Status: Completed
• Conditions: Colonoscopy; Ketamine; Fentanyl
• Intervention / Treatment: Drug: Ketamine; Device: patient control analgesia; Drug: fentanyl

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
• Enrollment (Actual): 120

Contacts and Locations

Study Locations

• Turkey
  • Kayseri
    • Develi, Kayseri, Turkey
      • Develi Hatice Muammer Kocatürk Devlet Hastanesi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

colonoscopy patients with ASA I-II group

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ketamine; ketamine used	Drug: Ketamine; sedation drugs; Device: patient control analgesia; patient control analgesia
fentanyl; fentanyl used	Device: patient control analgesia; patient control analgesia; Drug: fentanyl; sedation drugs

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Selda KAYAALTI

Publications and helpful links

General Publications

• Ferreira AO, Cravo M. Sedation in gastrointestinal endoscopy: Where are we at in 2014? World J Gastrointest Endosc. 2015 Feb 16;7(2):102-9. doi: 10.4253/wjge.v7.i2.102.
• Dal H., S. İzdeş, E. Kesimci, et al. Kolonoskopide sedasyon için propofolün aralıklı bolus veya hedef kontrollü infüzyon yöntemiyle uygulanmasının karşılaştırılması, Türk Anest Rean Der Dergisi, 2011; 39(3): 134-142
• Lee DW, Chan AC, Sze TS, Ko CW, Poon CM, Chan KC, Sin KS, Chung SC. Patient-controlled sedation versus intravenous sedation for colonoscopy in elderly patients: a prospective randomized controlled trial. Gastrointest Endosc. 2002 Nov;56(5):629-32. doi: 10.1067/mge.2002.128919.
• Poincloux L, Laquiere A, Bazin JE, Monzy F, Artigues F, Bonny C, Abergel A, Dapoigny M, Bommelaer G. A randomized controlled trial of endoscopist vs. anaesthetist-administered sedation for colonoscopy. Dig Liver Dis. 2011 Jul;43(7):553-8. doi: 10.1016/j.dld.2011.02.007. Epub 2011 Mar 29.
• Crepeau T, Poincloux L, Bonny C, Lighetto S, Jaffeux P, Artigue F, Walleckx P, Bazin JE, Dapoigny M, Bommelaer G. Significance of patient-controlled sedation during colonoscopy. Results from a prospective randomized controlled study. Gastroenterol Clin Biol. 2005 Nov;29(11):1090-6. doi: 10.1016/s0399-8320(05)82172-4.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2018
• Primary Completion (ACTUAL): June 1, 2018
• Study Completion (ACTUAL): June 1, 2018

Study Registration Dates

• First Submitted: July 13, 2018
• First Submitted That Met QC Criteria: July 23, 2018
• First Posted (ACTUAL): July 31, 2018

Study Record Updates

• Last Update Posted (ACTUAL): July 31, 2018
• Last Update Submitted That Met QC Criteria: July 23, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Ketamine; Fentanyl
• Other Study ID Numbers: 2018/94

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes