Phase 2
N=200
Recovery After Total Intravenous Anesthesia With Ketofol Versus Mixture of Ketofol and Lidocaine for Short Pediatric Surgery
Surgical Procedure, Unspecified
Bottom Line
View on ClinicalTrials.gov: NCT04467424 ↗Enrolled (actual)
200
Serious AEs
0.0%
Results posted
Feb 2021
Primary outcome: Primary: Effect of TIVA With Ketofol and Ketofol Plus Lidocaine on Extubation Time in Children — 240; 120 second
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- ketamine, propofol (Drug); ketamine, propofol, lidocaine (Drug)
- Age
- Pediatric · 1+ yrs
- Sex
- All
- Sponsor
- University Hospital of Split
- Primary completion
- Nov 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Effect of TIVA With Ketofol and Ketofol Plus Lidocaine on Extubation Time in Children |
240; 120 | — |
| PRIMARY Effect of TIVA With Ketofol and Ketofol Plus Lidocaine on Length of Stay in the PACU |
35; 20 | — |
| SECONDARY Effect of TIVA With Ketofol and Ketofol Plus Lidocaine on Total Opioid Consumption |
2.3; 2.1 | — |
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.
Eligibility Criteria
Inclusion Criteria
- surgical procedures max 60 min ASA I and II
Exclusion Criteria
- ASA > II surgical procedures longer than 60 min
Data sourced from ClinicalTrials.gov (NCT04467424). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.