Effects of Passive Smoking on Children During Gastrointestinal Endoscopy

Gastro-Intestinal Disorders Clinical Trial

Official title:

Effects of Passive Smoking on Children During Gastrointestinal Endoscopy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03920046
• Other study ID #: 2018/641
• Status: Completed
• Start date: January 2, 2019
• Est. completion date: March 1, 2021

Study information

• Verified date: March 2021
• Source: TC Erciyes University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

To evaluate the effect of passive smoking in children during Gastrointestinal Endoscopy.

Description:

When the patients and their parents are arrived in the endoscopy unıt about 1 h before the procedure, the anesthetist is obtained a medical history and carried out a physical examination and clinical assesment. Then the parents smoking habits are documented about to detect the magnitude of passive smoking. Endoscopist and anesthesiologist are blinded to the patients passive smoking history. Then the sedation is applied and esophagogastroduodenoscopy procedures performed. Side effects (e.g laryngospasm, coughing) during the study are recorded.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 518
• Est. completion date: March 1, 2021
• Est. primary completion date: March 1, 2021
• Gender: All
• Age group: 1 Year to 18 Years

Eligibility

Inclusion Criteria:

• ASA ( American Society of Anesthesiologists) I- ASA II patients

• Aged 1- 18 Year old patients

Exclusion Criteria:

• Smoker patients

Related Conditions & MeSH terms

• Digestive System Diseases
• Gastro-Intestinal Disorders
• Gastrointestinal Diseases
• Intestinal Diseases

Intervention

Behavioral:
• Control Group
The prevalence of laryngospasm in sedation applied to endoscopic intervention whose parents no smoking.

Locations

Country	Name	City	State
Turkey	Sibel Seçkin Pehlivan	Kayseri	Talas

Sponsors (1)

Lead Sponsor	Collaborator
TC Erciyes University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Chung HK, Lightdale JR. Sedation and Monitoring in the Pediatric Patient during Gastrointestinal Endoscopy. Gastrointest Endosc Clin N Am. 2016 Jul;26(3):507-25. doi: 10.1016/j.giec.2016.02.004. Review. — View Citation

Rodrigo C. The effects of cigarette smoking on anesthesia. Anesth Prog. 2000 Winter;47(4):143-50. Review. — View Citation

Tosun Z, Aksu R, Guler G, Esmaoglu A, Akin A, Aslan D, Boyaci A. Propofol-ketamine vs propofol-fentanyl for sedation during pediatric upper gastrointestinal endoscopy. Paediatr Anaesth. 2007 Oct;17(10):983-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	laryngospasm ratio	The prevalence of laryngospasm in sedation applied to endoscopic intervention whose parents smoking.	an average of 2 hours
Secondary	hypoxia ratio (oxygen saturation < % 90)	The prevalence of hypoxia (oxygen saturation < % 90) in sedation applied to endoscopic intervention whose parents smoking.	an average of 2 hours