Recovery After Total Intravenous Anesthesia With Ketofol Versus Mixture of Ketofol and Lidocaine for Short Pediatric Surgery
Lidoketofol
TIVA With Ketofol Versus Lidoketofol for Short-term Anesthesia on Pediatric Patients; Effects on Recovery
1 other identifier
interventional
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2020
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 20, 2020
CompletedFirst Submitted
Initial submission to the registry
June 27, 2020
CompletedFirst Posted
Study publicly available on registry
July 13, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 20, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 18, 2020
CompletedResults Posted
Study results publicly available
February 4, 2021
CompletedFebruary 4, 2021
January 1, 2021
5 months
June 27, 2020
November 11, 2020
January 15, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (1)
Effect of TIVA With Ketofol and Ketofol Plus Lidocaine on Total Opioid Consumption
up to 60 minutes
Study Arms (2)
Pediatric anesthesia with ketofol
EXPERIMENTALketamine, propofol
Pediatric anesthesia with ketofol plus lidocaine
EXPERIMENTALketamine, propofol, lidocaine
Interventions
anesthesia with ketofol plus lidocaine in pediatric surgery
Eligibility Criteria
You may qualify if:
- surgical procedures max 60 min ASA I and II
You may not qualify if:
- ASA \> II surgical procedures longer than 60 min
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital of Split
Split, 21000, Croatia
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Ana Nevescanin Biliskov, pediatric anesthesiologist
- Organization
- University Hospital of Split
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Pediatric anesthesiologist
Study Record Dates
First Submitted
June 27, 2020
First Posted
July 13, 2020
Study Start
June 20, 2020
Primary Completion
November 20, 2020
Study Completion
December 18, 2020
Last Updated
February 4, 2021
Results First Posted
February 4, 2021
Record last verified: 2021-01