Recovery After Total Intravenous Anesthesia With Ketofol Versus Mixture of Ketofol and Lidocaine for Short Pediatric Surgery (Lidoketofol)

• ClinicalTrials.gov Identifier: NCT04467424
• Recruitment Status: Completed
• First Posted: July 13, 2020
• Results First Posted: February 4, 2021
• Last Update Posted: February 4, 2021
• Sponsor: University Hospital of Split
• Information provided by (Responsible Party): Ana N Biliškov, MD, University Hospital of Split

Tracking Information

• First Submitted Date: June 27, 2020
• First Posted Date: July 13, 2020
• Results First Submitted Date: November 11, 2020
• Results First Posted Date: February 4, 2021
• Last Update Posted Date: February 4, 2021
• Actual Study Start Date: June 20, 2020
• Actual Primary Completion Date: November 20, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 15, 2021)

• 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 ]

Original Primary Outcome Measures (submitted: July 8, 2020)

• Effect of TIVA with ketofol and ketofol plus lidocaine on extubation time in children [ Time Frame: up to 24 weeks ]
• Effect of TIVA with ketofol and ketofol plus lidocaine on length of stay in the PACU [ Time Frame: up to 24 weeks ]

• Current Secondary Outcome Measures (submitted: January 15, 2021): Effect of TIVA With Ketofol and Ketofol Plus Lidocaine on Total Opioid Consumption [ Time Frame: up to 60 minutes ]
• Original Secondary Outcome Measures (submitted: July 8, 2020): Effect of TIVA with ketofol and ketofol plus lidocaine on total opioid consumption [ Time Frame: up to 24 weeks ]
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Recovery After Total Intravenous Anesthesia With Ketofol Versus Mixture of Ketofol and Lidocaine for Short Pediatric Surgery
• Official Title: TIVA With Ketofol Versus Lidoketofol for Short-term Anesthesia on Pediatric Patients; Effects on Recovery
• 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.

• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Investigator); Primary Purpose: Other
• Condition: Surgical Procedure, Unspecified

Intervention

• Drug: ketamine, propofol
  anesthesia with ketofol in pediatric surgery
• Drug: ketamine, propofol, lidocaine
  anesthesia with ketofol plus lidocaine in pediatric surgery

Study Arms

• Experimental: Pediatric anesthesia with ketofol
  ketamine, propofol
  Intervention: Drug: ketamine, propofol
• Experimental: Pediatric anesthesia with ketofol plus lidocaine
  ketamine, propofol, lidocaine
  Intervention: Drug: ketamine, propofol, lidocaine

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 8, 2020): 200
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: December 18, 2020
• Actual Primary Completion Date: November 20, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• surgical procedures max 60 min ASA I and II

Exclusion Criteria:

• ASA > II surgical procedures longer than 60 min

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 1 Year to 12 Years (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Croatia

Administrative Information

• NCT Number: NCT04467424
• Other Study ID Numbers: Ketofol-Lidocaine
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Ana N Biliškov, MD, University Hospital of Split
• Original Responsible Party: Same as current
• Current Study Sponsor: University Hospital of Split
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: University Hospital of Split
• Verification Date: January 2021