Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pediatric anesthesia with ketofol | Experimental | ketamine, propofol |
|
| Pediatric anesthesia with ketofol plus lidocaine | Experimental | ketamine, propofol, lidocaine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ketamine, propofol | Drug | anesthesia with ketofol in pediatric surgery |
| |
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of TIVA With Ketofol and Ketofol Plus Lidocaine on Total Opioid Consumption | up to 60 minutes |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Split | Split | 21000 | Croatia |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Pediatric Anesthesia With Ketofol | ketamine, propofol ketamine, propofol: anesthesia with ketofol in pediatric surgery |
| FG001 | Pediatric Anesthesia With Ketofol Plus Lidocaine |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 18, 2020 |
Not provided
Not provided
Not provided
Not provided
Not provided
| ketamine, propofol, lidocaine |
| Drug |
anesthesia with ketofol plus lidocaine in pediatric surgery |
|
ketamine, propofol, lidocaine
ketamine, propofol, lidocaine: anesthesia with ketofol plus lidocaine in pediatric surgery
| COMPLETED |
|
| NOT COMPLETED |
|
Age 1-12 years, male and female, for short surgery (max 60 min)
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Pediatric Anesthesia With Ketofol | ketamine, propofol ketamine, propofol: anesthesia with ketofol in pediatric surgery |
| BG001 | Pediatric Anesthesia With Ketofol Plus Lidocaine | ketamine, propofol, lidocaine ketamine, propofol, lidocaine: anesthesia with ketofol plus lidocaine in pediatric surgery |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Age 1-12 years old, male and female, for short pediatric surgery (max 60 min.) | Count of Participants | Participants |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| |||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| sevoflurane for iv cannula | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Effect of TIVA With Ketofol and Ketofol Plus Lidocaine on Extubation Time in Children | age 1-12, male and female, pediatric short surgery | Posted | Median | Inter-Quartile Range | second | up to 600 seconds |
|
|
| |||||||||||||||||||||||||||||
| Primary | Effect of TIVA With Ketofol and Ketofol Plus Lidocaine on Length of Stay in the PACU | Age 1-12 years, male and female, pediatric short surgery | Posted | Median | Inter-Quartile Range | minute | up to 40 minutes |
|
| ||||||||||||||||||||||||||||||
| Secondary | Effect of TIVA With Ketofol and Ketofol Plus Lidocaine on Total Opioid Consumption | Age 1-12 years, male and female, pediatric short surgery | Posted | Median | Inter-Quartile Range | microgram per kg | up to 60 minutes |
|
|
4 months
NO adverse event.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pediatric Anesthesia With Ketofol | ketamine, propofol ketamine, propofol: anesthesia with ketofol in pediatric surgery | 0 | 100 | 0 | 100 | 0 | 100 |
| EG001 | Pediatric Anesthesia With Ketofol Plus Lidocaine | ketamine, propofol, lidocaine ketamine, propofol, lidocaine: anesthesia with ketofol plus lidocaine in pediatric surgery | 0 | 100 | 0 | 100 | 0 | 100 |
Not provided
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ana Nevescanin Biliskov, pediatric anesthesiologist | University Hospital of Split | 00385912508001 | anevescanin@gmail.com |
| Jan 15, 2021 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D007649 | Ketamine |
| D015742 | Propofol |
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
| D000588 | Amines |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
|
|
|
|
|
|