Skip to content

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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20190511043550N1
Enrollment
18
Registered
2019-05-13
Start date
2019-06-12
Completion date
Unknown
Last updated
2019-05-21

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

Conditions

Emergence. Sedative, hypnotic, or anxiolytic related disorders

Interventions

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 t

Sponsors

Shiraz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
12 Months to 36 Months

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSudabeh Emami

Shiraz University of Medical Sciences

emami_s@sums.ac.ir+98 71 3235 7282

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 12, 2026