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

Colonoscopy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03607110
• Other study ID #: 2018/94
• Status: Completed
• Start date: March 1, 2018
• Est. completion date: June 1, 2018

Study information

• Verified date: July 2018
• Source: Develi Devlet Hastanesi
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: June 1, 2018
• Est. primary completion date: June 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Colonoscopy
• Fentanyl
• Ketamine

Intervention

Drug:
• Ketamine
sedation drugs
• fentanyl
sedation drugs

Device:
• patient control analgesia
patient control analgesia

Locations

Country	Name	City	State
Turkey	Develi Hatice Muammer Kocatürk Devlet Hastanesi	Develi	Kayseri

Sponsors (1)

Lead Sponsor	Collaborator
Selda KAYAALTI

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

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. — View Citation

Dal H., S. Izdes, E. Kesimci, et al. Kolonoskopide sedasyon için propofolün aralikli bolus veya hedef kontrollü infüzyon yöntemiyle uygulanmasinin karsilastirilmasi, Türk Anest Rean Der Dergisi, 2011; 39(3): 134-142

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. Review. — View Citation

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. — View Citation

Poincloux L, Laquière 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain level - VAS SCALE	Pain level assessed by VAS	during the operation
Primary	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	operation time	duration of operation time will be asssessed as min.	during the operation
Secondary	side effects questionnaire	Cardio pulmonary side effects (Hypotension, Bradycardia, Desaturation) and other side effects (Nausea and Vomiting, Headache)	during the operation