Surgical Procedure, Unspecified
Conditions
Brief summary
Two hundred children aged 1-12 years undergoing short surgery will be randomized into two groups. Ketofol will be used for induction and maintenance of anesthesia in group l. .Ketofol with lidocaine will be prepared for group ll. A reducted McFarlan infusion dose will be used. Extubating time, duration of anesthesia, length of stay in post-anesthesia care unit (PACU) will be recorded.
Detailed description
Aim of the research: In this study investigators want to examine the effectiveness of the use of ketofol and a mixture of ketofol and lidocaine on the total consumption of opioids and on the postoperative recovery of pediatric patients. Investigators will evaluate the safety, efficacy, and outcomes of the anesthesia procedure with respect to the administration of different anesthetics, specific pharmakocinetic profiles and compare the length of recovery between patients in two groups. Including criteria: children aged 1 to 12 years who underwent short surgery (up to 60 min). Primary and secondary outcome measures: The primary outcome of this study will be extubation time and the secondary outcome will be time spend in PACU. Description of the study: Each subject included in the study will be given general anesthesia with ketofol or ketofol and lidocaine, with the addition of fentanyl. After 20 s the LMA will be placed. Maintenance of anesthesia will be performed using an air / oxygen mixture (50% / 50%) and an infusion of ketofol or ketofol and lidocaine. Ketofol will be prepare in a ratio of 1: 4 for induction and 1: 7 for maintenance. The same mixtures of ketofol will be added 1 ml of 2% lidocaine for the second group of patients. After extubation, patients will be transferred to the PACU.
Interventions
DRUGketamine, propofol
anesthesia with ketofol in pediatric surgery
DRUGketamine, propofol, lidocaine
anesthesia with ketofol plus lidocaine in pediatric surgery
Sponsors
University Hospital of Split
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
1 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
* surgical procedures max 60 min ASA I and II
Exclusion criteria
* ASA \> II surgical procedures longer than 60 min
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effect of TIVA With Ketofol and Ketofol Plus Lidocaine on Extubation Time in Children | up to 600 seconds |
| Effect of TIVA With Ketofol and Ketofol Plus Lidocaine on Length of Stay in the PACU | up to 40 minutes |
Secondary
| Measure | Time frame |
|---|---|
| Effect of TIVA With Ketofol and Ketofol Plus Lidocaine on Total Opioid Consumption | up to 60 minutes |
Countries
Croatia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pediatric Anesthesia With Ketofol ketamine, propofol
ketamine, propofol: anesthesia with ketofol in pediatric surgery | 100 |
| Pediatric Anesthesia With Ketofol Plus Lidocaine ketamine, propofol, lidocaine
ketamine, propofol, lidocaine: anesthesia with ketofol plus lidocaine in pediatric surgery | 100 |
| Total | 200 |
Baseline characteristics
| Characteristic | Pediatric Anesthesia With Ketofol | Pediatric Anesthesia With Ketofol Plus Lidocaine | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 100 Participants | 100 Participants | 200 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment Croatia | 100 participants | 100 participants | 200 participants |
| sevoflurane for iv cannula | 64 Participants | 54 Participants | 118 Participants |
| Sex: Female, Male Female | 22 Participants | 19 Participants | 41 Participants |
| Sex: Female, Male Male | 78 Participants | 81 Participants | 159 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 100 | 0 / 100 |
| other Total, other adverse events | 0 / 100 | 0 / 100 |
| serious Total, serious adverse events | 0 / 100 | 0 / 100 |
Outcome results
Primary
Effect of TIVA With Ketofol and Ketofol Plus Lidocaine on Extubation Time in Children
Time frame: up to 600 seconds
Population: age 1-12, male and female, pediatric short surgery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pediatric Anesthesia With Ketofol | Effect of TIVA With Ketofol and Ketofol Plus Lidocaine on Extubation Time in Children | 240 second |
| Pediatric Anesthesia With Ketofol Plus Lidocaine | Effect of TIVA With Ketofol and Ketofol Plus Lidocaine on Extubation Time in Children | 120 second |
Primary
Effect of TIVA With Ketofol and Ketofol Plus Lidocaine on Length of Stay in the PACU
Time frame: up to 40 minutes
Population: Age 1-12 years, male and female, pediatric short surgery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pediatric Anesthesia With Ketofol | Effect of TIVA With Ketofol and Ketofol Plus Lidocaine on Length of Stay in the PACU | 35 minute |
| Pediatric Anesthesia With Ketofol Plus Lidocaine | Effect of TIVA With Ketofol and Ketofol Plus Lidocaine on Length of Stay in the PACU | 20 minute |
Secondary
Effect of TIVA With Ketofol and Ketofol Plus Lidocaine on Total Opioid Consumption
Time frame: up to 60 minutes
Population: Age 1-12 years, male and female, pediatric short surgery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pediatric Anesthesia With Ketofol | Effect of TIVA With Ketofol and Ketofol Plus Lidocaine on Total Opioid Consumption | 2.3 microgram per kg |
| Pediatric Anesthesia With Ketofol Plus Lidocaine | Effect of TIVA With Ketofol and Ketofol Plus Lidocaine on Total Opioid Consumption | 2.1 microgram per kg |