Comparison of the Effect of Caffeine Citrate with Placebo on the Wake-Up Rate of Children 12-36 months After Outpatient Surgery under General Anesthesia with Inhaled Anesthetics

Phase 2

• Conditions: Emergence.; Sedative, hypnotic, or anxiolytic related disorders

• Registration Number: IRCT20190511043550N1
• Lead Sponsor: Shiraz University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 21 May 2019

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

Age 12 to 36 months
(ASA I)
Duration of surgery less than one hour

Exclusion Criteria

History of seizure
Heart rate > 150
Asthma
Airway irritability
Heart disease
Hyperactivity
Cerebrovascular accidents
Obstructive sleep apnea
Emergency surgeries
Unsuccessful ventilation with laryngeal mask.
Rising ETco2> 40 mmHg,
Common cold

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Emergence. Timepoint: During induction of anesthesia until the removal of the laryngeal mask airway after surgery. Method of measurement: The laryngeal mask removal and when the baby opens his/her eyes and moves the four limbs purposefully.;Systolic blood pressure. Timepoint: At the time of initiation of the induction, onset of surgery, injection of the drug, 5 minutes after the injection, removal of the laryngeal mask, arrival to the recovery, 30 minutes after the injection, recovery discharge. Method of measurement: Monitoring.;Diastolic blood pressure. Timepoint: At the time of initiation of the induction, onset of surgery, injection of the drug, 5 minutes after the injection, removal of the laryngeal mask, arrival to the recovery, 30 minutes after the injection, recovery discharge. Method of measurement: Monitoring.

Secondary Outcome Measures

Name	Time	Method
Dysrhythmia. Timepoint: The onset of anesthesia induction, the onset of surgery, the injection time of caffeine citrate or placebo, removal of the laryngeal mask ,When the child leaves the operating room to enter the recovery room. Method of measurement: Monitoring.;Nausea and Vomiting. Timepoint: The onset of anesthesia induction, the onset of surgery, the injection time of caffeine citrate or placebo, removal of the laryngeal mask ,When the child leaves the operating room to enter the recovery room. Method of measurement: Observation.;Cyanosis. Timepoint: The onset of anesthesia induction, the onset of surgery, the injection time of caffeine citrate or placebo, removal of the laryngeal mask ,When the child leaves the operating room to enter the recovery room. Method of measurement: Observation.