]>
IRCT20190511043550N1 IRCT 2019-05-13 Shiraz University of Medical Sciences 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 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 2019-06-12 anticipated 18 Complete https://irct.ir/trial/39437 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be based on the randomization table, which is derived from www.randomization.org, Blinding description: In the intervention group: 20 cc syringe containing caffeine citrate with a dose of 10 mg per kg diluted with distilled water is prepared and supplied to the researcher by a person who is unaware of the study phases and will be administered to the patients in the intervention group. In the control group, a syringe of the same size as the intervention group (containing 20 cc distilled water) is provided by a person who is unaware of the study groups and provided to the researcher. 2-3 Emergence. Intervention 1: Intervention group: sevfluorine is discontinued in the suturing process and 20 cc syringes containing 10 mg / kg of caffeine citrate diluted with distilled water will be administered to the patients in the intervention group.ge. Intervention 2: Control group: : In the control group,patients received 20 cc of distilled water in 20cc syrin. No - There is not a plan to make this available Justification or reason for not sharing IPD is It is against our policies.
public Sudabeh Emami
Anesthesiology Department, Shahid Faghihi Hospital, Zand street
Shiraz Iran (Islamic Republic of) 7134844119 +98 71 3235 7282 emami_s@sums.ac.ir Shiraz University of Medical Sciences scientific Ashkan Panah
Anesthesiology Department, Faghihi Hospital, Zand Street
Shiraz Iran (Islamic Republic of) 7134844119 +98 71 3647 4270 panah@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Age 12 to 36 months (ASA I) Duration of surgery less than one hour 12 months 36 months Both 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 F13 Sedative, hypnotic, or anxiolytic related disorders Treatment - Drugs Placebo Intervention group: sevfluorine is discontinued in the suturing process and 20 cc syringes containing 10 mg / kg of caffeine citrate diluted with distilled water will be administered to the patients in the intervention group.ge Control group: : In the control group,patients received 20 cc of distilled water in 20cc syrin 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. 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. Shiraz University of Medical Sciences Approved 2019-04-09 Ethics committee of Shiraz University of Medical Sciences Vice Chancellor of research, Shiraz University of Medical Sciences, 7th floor, central building of Shiraz University of Medical Sciences, Zand street Shiraz Fars Iran (Islamic Republic of)