We conducted a double blind Randomised Clinical Trial to study the effect of intravenous Lidocaine on emergence agitation of Sevoflurane in children with retinoblastoma undergoing eye examination under general anesthesia. 120 children with retinoblastoma that met the inclusion criteria were randomly divided into 4 groups (using block randomization). There were 30 cases in each group. Group 1: Sodium Thiopental _Lidocaine, Group 2: Pofol_Lidocaine, Group 3: Sodium Thiopental _Saline, Group 4: Pofol_Saline After monitoring, Sevoflurane with Minimal Alveolar Concentration (MAC) of %4 was administered for induction. After inserting an iv canula Thiopental Sodium was injected (5Mg/Kg) for groups 1 and 2, and Pofol was injected for groups 3 and 4, (2Mg/Kg). Immediately after examination, Lidocaine (1.5mg/kg) was administered for groups 1 and 3, and saline was administered for groups 2 and 4 with same dose. Finally, agitation rate was determined by anesthesiologist. Patient and anesthesiologist were not aware of the type of drugs and only operating room technician was aware of prescribed drugs for patients (blindness). Anesthesiologist divided children into 5 levels based on agitation: 1. Asleep; 2. Awake and calm; 3. Irritable or consolable crying; 4. Inconsolable crying; and 5. Severe restlessness. The scores were recorded every 10 minutes after transfer of patients into recovery and compared in the four groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013072914199N1
Registration date:2013-09-23, 1392/07/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-09-23, 1392/07/01
Registrant information
Name
Leila Mounesan
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6641 9763
Email address
l-mounesan@farabi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Deputy of Tehran University of Medical Sciences
Expected recruitment start date
2012-03-22, 1391/01/03
Expected recruitment end date
2013-07-21, 1392/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of two anesthetic regimens Pofol-Lidocaine and Thiopental - Lidocaine on control of emergence agitation due to Sevoflurane in children
Public title
The effect of Lidocaine on control of emergence agitation due to Sevoflurane
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Parent willingness to participate in the study and informed consent, Age group: 12 to 36 months, Retinoblastoma eyes Exclusion criteria: A history of seizures, Liver disease, Kidney disease, Heart disease, Having a cold during the current week, Sensitivity to Lidocaine, Intense crying
Age
From 1 year old to 3 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Fourth Floor, No.23 ,16th Azar Ave., Keshavarz Blvd., Tehran
City
Tehran
Postal code
Approval date
2012-05-13, 1391/02/24
Ethics committee reference number
90/د/2799/130
Health conditions studied
1
Description of health condition studied
Agitation
ICD-10 code
R45.1
ICD-10 code description
Restlessness and agitation
Primary outcomes
1
Description
Agitation
Timepoint
The scores were recorded every 10 minutes (In the first 30 minutes after entering into recovery), since the children transferred to recovery
Method of measurement
Anesthesiologist divided children into 5 levels based on agitation: 1. Asleep; 2. Awake and calm; 3. Irritable or consolable crying; 4. Inconsolable crying; and 5. Severe restlessness
Secondary outcomes
1
Description
Nausea and vomiting
Timepoint
The symptoms were recorded every 10 minutes (In the first 30 minutes after entering into recovery), since the children transferred to recovery
Method of measurement
Observation
Intervention groups
1
Description
Group2: Pofol 2mg/kg and Lidocaine 1.5mg/kg Pofol administration: IV, Frequency of use: Once and after induction of anesthesia with sevoflurane to maintain anesthesia, Manufacturer: Germany Lidocain administration: IV, Frequency of use: Once or immediately after an eye examination Manufacturer: Rasht - Iran
Category
Treatment - Drugs
2
Description
Group1: Was administered Sodium Thiopental 5mg/kg and Lidocaine 1.5mg/kg Lidocain administration: IV, Frequency of use: Once or immediately after an eye examination Manufacturer: Rasht - Iran Sodium Thiopental administration: IV, Frequency of use: Once and after induction of anesthesia with sevoflurane to maintain anesthesia, Manufacturer: India
Category
Treatment - Drugs
3
Description
Group3: Was administered Sodium Thiopental 5mg/kg and an equivalent amount of Saline Sodium Thiopental administration: IV, Frequency of use: Once and after induction of anesthesia with sevoflurane to maintain anesthesia, Manufacturer: India
Category
Treatment - Drugs
4
Description
Group4: Pofol 2mg/kg and an equivalent amount of Saline Pofol administration: IV, Frequency of use: Once and after induction of anesthesia with sevoflurane to maintain anesthesia, Manufacturer: Germany