Clinical trial NCT04467424
Conditions: Surgical Procedure, Unspecified
Sponsor: University Hospital of Split
Start date: 2020-06-20; Completion date: 2020-12-18
Enrollment: 200 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

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.

Arms: arm 1: ketamine, propofol arm 2: ketamine, propofol, lidocaine
Interventions: intervention 1: ketamine, propofol intervention 2: ketamine, propofol, lidocaine
Intervention descriptions: intervention 1: anesthesia with ketofol in pediatric surgery intervention 2: anesthesia with ketofol plus lidocaine in pediatric surgery

Protocol documents:
Prot_SAP_000.pdf: 
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TIVA With Ketofol Versus Lidoketofol for Short-term Anesthesia on  
Pediatric Patients; Effects on Recovery  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  


[upišite ovdje]  
18. December 2020.  
  
  
METHODS  
  
Patients  
Randomized, prospective study will be performed between July  2020 and November 2020.  
Two hundred pediatric patients aged 1–12 years with an American Society of  
Anesthesiologists status of I to II, schedule for elective short-term surgery, will be recruited. 
Hundred will be in the ketofol group and hundred in lidoketofol group. Demographic data 
including age and sex and also the duration of anesthesia in the two groups will be similar. The 
children will not be premedicated. If an intravenous (IV) cannula will not be inserted 
preoperatively, anesthesia will be induced with 4–5% sevoflurane via a face mask. After that, 
the sevoflurane will be stopped and induction drugs will be administered intravenously.  
  
Intraoperative monitoring  
Electrocardiogram (ECG), non-invasive arterial blood pressure, and peripheral oxygen 
saturation (Draeger-Perseus A500 Anesthesia Device Monitor, Draeger Medical Systems, Inc., 
Denver, MA) will be used for standard monitoring. A bispectral indeks monitoring system (BIS;  
BIS™ Brain Monitoring System, Covidien, San Jose, CA) will be used to measure depth of 
anesthesia. Systolic blood pressure (SBP), mean arterial blood pressure (MAP), diastolic blood 
pressure (DAP), heart rate (HR), and BIS values will be recorded at 5-min intervals during 
anesthesia.  
  
Study design  
The patients will be randomly allocated into two groups, via a computer-generated 
randomization list. Ketofol and lidoketofol will be prepared in one syringe. A Draeger™ Module 
DPS syringe pump (Draeger Medical Systems, Inc., Denver, MA) will be used for infusion of 
the ketofol and lidiketofol mixture. On arrival at the operating room, standard anesthetic 
monitoring including non-invasive blood pressure, electrocardiogram and pulse oximeter will 
be applied. General anesthesia will be induced by ketofol or lidoketofol and fentanyl, and after 
20 s, the LMA will be inserted [13]. Mechanical ventilation will be performed to maintain the ET-
CO2 between 35-45 mmHg. Maintenance of anesthesia will be done using air/oxygen 
(50%/50%) and infusion of ketofol or lidoketofol. Randomization will be performed by random 
blocks (n=4). Ketofol will be prepared at  ratio of 1:4 for induction and 1:7 for maintenance.  


[upišite ovdje]  
Lidoketofol group will be prepared with ketofol at same ratio plus lidocaine. Extubating time 
waill be defined as the time between discontinuation of the infusion and extubation. The LMA 
will be removed when spontaneous regular breathing was confirmed. Children will be 
transferred to the PACU, where respiratory, heart rate and peripheral oxygen saturation (SpO2) 
will be recorded. The length of staying in PACU will be defined as time between arrival and 
discharge time. All patients will be observed for 24 h postoperatively, and will be closely 
followed for propofol infusion syndrome (PRIS).  
  
Primary and secondary outcomes  
The primary outcome of this study will be extubating time. Secondary outcomes will be time 
spent in the PACU and total opioid consuption.  
  
Statistical analysis  
The data weill be analyzed using Statistical Package for the Social Sciences software, version 
24.0 (SPSS Statistics for Windows IBM Corp, Armonk, NY). Distributions of quantitative data 
will be described by medians and interquartile ranges, whereas absolute rates and percentages 
will be used to describe categorical data. Differences in median values of quantitative variables 
between the groups of patients will be tested with Mann–Whitney U test. The chi-square test 
will be used for the statistical analysis of the categorical data. All values of P<0.05 will be  
considered to indicate statistical significance.  
  
Results   
Extubating time was significantly lower in lidoketofol group than in ketofol group (120 s versus 
240 s; p < 0.00001). Length of stay in the PACU was lower in lidoketofol  group  than in ketofol 
group (20 min vs. 35 min; p<0.00001). Fentanyl (2,1 µg per kg  vs. 2,3 µg per kg  P<0.0056) 
and propofol (6,6 mg per kg vs. 7,6 mg per kg ; P<0.032) consumption per kg were significantly 
lower in lidoketofol group.  
  
  
  
  
  


[upišite ovdje]  
Human Subjects 
Review:  
  
University Hospital of Split            
Split, Croatia, 21000        
Contact: Ana Nevešćanin  
Biliškov,Mr.sc.MD    00385912508001    anevescanin@gmail.com  
Board Status: Approved     Approval Number: 2181-147- 
01/06/M.S.-20-12  
Board Name: Etičko povjerenstvo  
Board Affiliation: Klinički bolnički centar 
Split Phone: +38521556200   Email: 
eticko.povjerenstvo@kbsplit.hr Address:  
KBCSplit  
Spinčićeva 1  
Split  
Hrvatska