The prevalence of respiratory complications in two methods of anesthesia with endotracheal intubation and without endotracheal intubation

Comparison of the prevalence of respiratory complications in two methods of anesthesia with endotracheal intubation and without endotracheal intubation in children under two years old candidate for endoscopy

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200518047491N1

Enrollment

120

Registered

2020-08-26

Start date

2020-07-22

Completion date

Unknown

Last updated

2020-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Children under two years of age who present with gastrointestinal symptoms and are candidates for endoscopy under the diagnosis of a pediatric gastroenterologist.

Interventions

Intervention 1: Control group: sedation without tracheal intubation, after confirming adequate fasting (6 hours for foods and milk, 4 hours for breast milk, 2 hours for clear liquids) if they are over

Eligibility

Sex/Gender

All

Age

1 Days to 2 Years

Inclusion criteria

Inclusion criteria: Being in ASA Class I & II Admitted outpatient or inpatient

Exclusion criteria

Exclusion criteria: Emergent patients ASA Class III and higher

Design outcomes

Primary

Measure	Time frame
O2 saturation. Timepoint: Duration of endoscopy until the end of recovery and discharge from the endoscopy unit. Method of measurement: questionnaire.;Respiratory rate. Timepoint: Duration of endoscopy until the end of recovery and discharge from the endoscopy unit. Method of measurement: questionnaire.;Heart rate. Timepoint: Duration of endoscopy until the end of recovery and discharge from the endoscopy unit. Method of measurement: questionnaire.;Blood pressure. Timepoint: Duration of endoscopy until the end of recovery and discharge from the endoscopy unit. Method of measurement: questionnaire.;ECG changes. Timepoint: Duration of endoscopy until the end of recovery and discharge from the endoscopy unit. Method of measurement: questionnaire.;Duration of anesthesia. Timepoint: time from starting the anesthesia to patient awakening. Method of measurement: questionnaire.;Duration of endoscopy. Timepoint: From the beginning of the endoscopy to the exit of the endoscope from the patient's mouth. Method of measurement: questionnaire.;Laryngospasm complication during anesthesia. Timepoint: From the beginning of anesthesia to the end of anesthesia. Method of measurement: questionnaire.;Bronchospasm complication during anesthesia. Timepoint: From the beginning of anesthesia to the end of anesthesia. Method of measurement: questionnaire.;Patient movement during anesthesia. Timepoint: From the beginning of anesthesia to the end of anesthesia. Method of measurement: questionnaire.;Bucking and coughing during anesthesia. Timepoint: From the beginning of anesthesia to the end of anesthesia. Method of measurement: questionnaire.;Nausea and vomiting. Timepoint: From the start of anesthesia to discharge from recovery. Method of measurement: questionnaire.;Seizure. Timepoint: From the start of anesthesia to discharge from recovery. Method of measurement: questionnaire.;Apnea. Timepoint: From the start of anesthesia to discharge from recovery. Method of measurement: questionnaire.;S	—

Measure

Time frame

O2 saturation. Timepoint: Duration of endoscopy until the end of recovery and discharge from the endoscopy unit. Method of measurement: questionnaire.;Respiratory rate. Timepoint: Duration of endoscopy until the end of recovery and discharge from the endoscopy unit. Method of measurement: questionnaire.;Heart rate. Timepoint: Duration of endoscopy until the end of recovery and discharge from the endoscopy unit. Method of measurement: questionnaire.;Blood pressure. Timepoint: Duration of endoscopy until the end of recovery and discharge from the endoscopy unit. Method of measurement: questionnaire.;ECG changes. Timepoint: Duration of endoscopy until the end of recovery and discharge from the endoscopy unit. Method of measurement: questionnaire.;Duration of anesthesia. Timepoint: time from starting the anesthesia to patient awakening. Method of measurement: questionnaire.;Duration of endoscopy. Timepoint: From the beginning of the endoscopy to the exit of the endoscope from the patient's mouth. Method of measurement: questionnaire.;Laryngospasm complication during anesthesia. Timepoint: From the beginning of anesthesia to the end of anesthesia. Method of measurement: questionnaire.;Bronchospasm complication during anesthesia. Timepoint: From the beginning of anesthesia to the end of anesthesia. Method of measurement: questionnaire.;Patient movement during anesthesia. Timepoint: From the beginning of anesthesia to the end of anesthesia. Method of measurement: questionnaire.;Bucking and coughing during anesthesia. Timepoint: From the beginning of anesthesia to the end of anesthesia. Method of measurement: questionnaire.;Nausea and vomiting. Timepoint: From the start of anesthesia to discharge from recovery. Method of measurement: questionnaire.;Seizure. Timepoint: From the start of anesthesia to discharge from recovery. Method of measurement: questionnaire.;Apnea. Timepoint: From the start of anesthesia to discharge from recovery. Method of measurement: questionnaire.;S

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactNastaransadat Mahdavi

Shahid Beheshti University of Medical Sciences

nasimahdavi@gmail.com+98 21 2225 0680

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026