A Comparison of the Sedation During Endoscopy in Children

Kanuni Sultan Suleyman Training and Research Hospital

Status and phase

Completed

Phase 4

Conditions

Failed Moderate Sedation During Procedure

Treatments

Drug: Propofol and Fentanyl

Drug: Ketamine and Midazolam

Study type

Interventional

Funder types

Other

Identifiers

NCT02732132

2015/18

Details and patient eligibility

About

The primary aim of this study was to investigate the efficiency and safety of midazolam plus ketamine versus fentanyl plus propofol administered to children undergoing UGE and to determine the most appropriate sedation protocol.

Full description

The patients were given a spray of lidocaine 10% as a topical pharyngeal anaesthesia before sedation. Intravenous midazolam bolus dose 0.1 mg/kg (maximum 4 mg) was administered to Group A. Two minutes later, ketamine bolus dose 1 mg/kg was given intravenously. Patient responses to verbal and tactile stimuli were evaluated two minutes after ketamine application. Ketamine 0.5 mg/kg (maximum of 2 mg/kg) was added in two minute intervals if adequate sedation was not achieved initially. The endoscopy process was initiated by the endoscopist if there was no response. If the patients were agitated after the procedure started, a ketamine 0.5 mg/kg single dose was applied. Intravenous fentanyl bolus dose 1µg/kg was administered to Group B. Two minutes later, propofol bolus dose 1 mg/kg was given intravenously. Patient responses to verbal and tactile stimuli were evaluated two minutes after propofol application. Propofol 0.5 mg/kg was added in two minute intervals if adequate sedation was not achieved. The endoscopy process was initiated by the endoscopist if there was no response. If the patients were agitated after the procedure started, a propofol 0.5 mg/kg single dose was applied. None of the patients were given an antidote after the process during recovery.

All patients were monitored for peripheral oxygen saturation, heart rate (HR), respiratory rate, and RSS during the procedure. Oxygen (2L/min) by nasal cannula was given to all patients during the procedure. Hypoxia (peripheral oxygen saturation <90% during 60 seconds), apnea, laryngospasm, tachycardia (defined as 30% more than the average heart rate by age), bradycardia (30% less than the average heart rate by age), increase in oral secretions (more than enough to warrant aspiration), flushing, coughing and vomiting were assessed as complications and recorded.

Enrollment

238 patients

Sex

All

Ages

4 to 17 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

All the patients were in ASA (American Society of Anesthesiologists) physical status I or II.

Exclusion criteria

Patients with respiratory tract infections, glaucoma, psychosis, porphyria, hypertension, metabolic or neurologic diseases, increased intracranial pressure and intracranial mass, and patients known to be allergic to the drugs used were excluded from the study.