Surgical Procedure, UnspecifiedPhase 2LidoketofolNCT04467424
Recovery After Total Intravenous Anesthesia With Ketofol Versus Mixture of Ketofol and Lidocaine for Short Pediatric Surgery
A Phase 2 study testing ketamine, propofol and ketamine, propofol, lidocaine in people with Surgical Procedure, Unspecified, run by University Hospital of Split at 1 site in Croatia.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 12 years
- Conditions the study is for
- Surgical Procedure, Unspecified
- What is being tested?
- ketamine, propofol and ketamine, propofol, lidocaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteCroatia
- Study dates
- 20 Jun 2020to 18 Dec 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- surgical procedures max 60 min ASA I and II
Who cannot join
- ASA > II surgical procedures longer than 60 min
Trial locations and contacts
1 site in 1 country.
About this study
Official title: TIVA With Ketofol Versus Lidoketofol for Short-term Anesthesia on Pediatric Patients; Effects on Recovery
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.
Read the 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.
- Conditions
- Surgical Procedure, Unspecified
- Being tested
- ketamine, propofol, ketamine, propofol, lidocaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ketamine, propofolDrug
anesthesia with ketofol in pediatric surgery
ketamine, propofol, lidocaineDrug
anesthesia with ketofol plus lidocaine in pediatric surgery
| Study group | Role | What they receive |
|---|---|---|
| Pediatric anesthesia with ketofol | Experimental | ketamine, propofol Receives: Drug: ketamine, propofol |
| Pediatric anesthesia with ketofol plus lidocaine | Experimental | ketamine, propofol, lidocaine Receives: Drug: ketamine, propofol, lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of TIVA With Ketofol and Ketofol Plus Lidocaine on Extubation Time in Children
Measured: up to 600 seconds
Effect of TIVA With Ketofol and Ketofol Plus Lidocaine on Length of Stay in the PACU
Measured: up to 40 minutes
Secondary outcomes (1)
Effect of TIVA With Ketofol and Ketofol Plus Lidocaine on Total Opioid Consumption
Measured: up to 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2020
- Study start20 Jun 2020
- Primary completion20 Nov 2020
- Study completion18 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Surgical Procedure, UnspecifiedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of Split
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana N Biliškov, MD, University Hospital of Split
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04467424
- Sponsor's protocol ID
- Ketofol-Lidocaine
- Acronym
- Lidoketofol
- Status last verified
- Jan 2021
- First submitted
- 27 Jun 2020
- Last updated
- 4 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TIVA With Ketofol Versus Lidoketofol for Short-term Anesthesia on Pediatric Patients; Effects on Recovery
- ClinicalTrials.gov ID
- NCT04467424
- Acronym / sponsor ID
- Lidoketofol / Ketofol-Lidocaine
- Conditions
- Surgical Procedure, Unspecified
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University Hospital of SplitUniversity, hospital or other
- Study start
- 20 Jun 2020 (actual)
- Primary completion
- 20 Nov 2020 (actual)
- Study completion
- 18 Dec 2020 (actual)
- First posted
- 13 Jul 2020 (actual)
- Results
- Posted 4 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pediatric anesthesia with ketofol | Experimental | Drug: ketamine, propofolketamine, propofol |
| Pediatric anesthesia with ketofol plus lidocaine | Experimental | Drug: ketamine, propofol, lidocaineketamine, propofol, lidocaine |
Who may qualify
- Ages
- 1 year to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- surgical procedures max 60 min ASA I and II
Key exclusion criteria (1 listed)
- ASA > II surgical procedures longer than 60 min
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ketamine, propofolanesthesia with ketofol in pediatric surgery | Drug | Pediatric anesthesia with ketofol |
| ketamine, propofol, lidocaineanesthesia with ketofol plus lidocaine in pediatric surgery | Drug | Pediatric anesthesia with ketofol plus lidocaine |
Primary outcome
Effect of TIVA With Ketofol and Ketofol Plus Lidocaine on Extubation Time in Children
Time frame: up to 600 seconds
Effect of TIVA With Ketofol and Ketofol Plus Lidocaine on Length of Stay in the PACU
Time frame: up to 40 minutes
1 secondary outcome
Effect of TIVA With Ketofol and Ketofol Plus Lidocaine on Total Opioid Consumption
Time frame: up to 60 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ketamine, propofol and ketamine, propofol, lidocaine in people with Surgical Procedure, Unspecified, run by University Hospital of Split at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of TIVA With Ketofol and Ketofol Plus Lidocaine on Extubation Time in Children (time frame: up to 600 seconds). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2021.