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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

Protocol summary

Study aim
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
Design
Double blind randomized clinical trial.
Settings and conduct
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. Control group: In the control group, 20 cc of distilled water were received in 20cc syringe.
Participants/Inclusion and exclusion criteria
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, surgery, rising ETco2> 40 mmHg, Unsuccessful ventilation with laryngeal mask.
Intervention groups
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. Control group: In the control group, 20 cc of distilled water were received in 20cc syringe.
Main outcome variables
Emergence, Systolic blood pressure, diastolic blood pressure

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190511043550N1
Registration date: 2019-05-13, 1398/02/23
Registration timing: prospective

Last update: 2019-05-13, 1398/02/23
Update count: 0
Registration date
2019-05-13, 1398/02/23
Registrant information
Name
Ashkan Panah
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4270
Email address
panah@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-12, 1398/03/22
Expected recruitment end date
2019-09-13, 1398/06/22
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
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
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
From 12 months old to 36 months old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
Sample size
Target sample size: 18
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be based on the randomization table, which is derived from www.randomization.org.
Blinding (investigator's opinion)
Double blinded
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.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Vice Chancellor of research, Shiraz University of Medical Sciences, 7th floor, central building of Shiraz University of Medical Sciences, Zand street
City
Shiraz
Province
Fars
Postal code
7134844119
Approval date
2019-04-09, 1398/01/20
Ethics committee reference number
IR.SUMS.MED.REC.1398.080

Health conditions studied

1

Description of health condition studied
Emergence
ICD-10 code
F13
ICD-10 code description
Sedative, hypnotic, or anxiolytic related disorders

Primary outcomes

1

Description
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.

2

Description
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

3

Description
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 outcomes

1

Description
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

2

Description
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

3

Description
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

Intervention groups

1

Description
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
Category
Treatment - Drugs

2

Description
Control group: : In the control group,patients received 20 cc of distilled water in 20cc syrin
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Namazi Hospital
Full name of responsible person
Sudabeh Emami
Street address
Namazi Hospital, Namazi Square
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3647 4270
Email
namazi@sums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Younes Ghasemi
Street address
Vice chancellor of research,7th floor of central building of Shiraz University of Medical Sciences, Zand street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3647 4270
Email
sacrc@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Sudabeh Emami
Position
Physician/pediatric anesthesia fellowship
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology Department, Shahid Faghihi Hospital, Zand street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3235 7282
Email
emami_s@sums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Ashkan Panah
Position
Pediatric Anesthesiologist
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3647 4270
Email
panah@sums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Ashkan Panah
Position
Pediatric Anesthesiologist
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3647 4270
Email
panah@sums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
It is against our policies.
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
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