Clinical Trials Logo
  1. Home
  2. Surgical Procedure, Unspecified
  3. NCT04467424
  4. Details
NCT04467424 Clinical Trial

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

Surgical Procedure, Unspecified Clinical Trial

— Lidoketofol  

Official title:
TIVA With Ketofol Versus Lidoketofol for Short-term Anesthesia on Pediatric Patients; Effects on Recovery

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04467424
Other study ID # Ketofol-Lidocaine
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date June 20, 2020
Est. completion date December 18, 2020

Study information
Verified date January 2021
Source University Hospital of Split
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. Extubating time, duration of anesthesia, length of stay in post-anesthesia care unit (PACU) will be recorded.

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.

Recruitment information / eligibility
Status Completed
Enrollment 200
Est. completion date December 18, 2020
Est. primary completion date November 20, 2020
Accepts healthy volunteers No
Gender All
Age group 1 Year to 12 Years
Eligibility Inclusion Criteria: - surgical procedures max 60 min ASA I and II Exclusion Criteria: - ASA > II surgical procedures longer than 60 min

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Croatia University Hospital of Split Split

Sponsors (1)
Lead Sponsor Collaborator
University Hospital of Split

Country where clinical trial is conducted

Croatia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Effect of TIVA With Ketofol and Ketofol Plus Lidocaine on Extubation Time in Children up to 600 seconds
Primary Effect of TIVA With Ketofol and Ketofol Plus Lidocaine on Length of Stay in the PACU up to 40 minutes
Secondary Effect of TIVA With Ketofol and Ketofol Plus Lidocaine on Total Opioid Consumption up to 60 minutes
See also
  Status Clinical Trial Phase
Completed NCT03299920 - Opioid Consumption After Knee Arthroscopy N/A
Completed NCT04061629 - Minimal Occlusive Pressure With Cuffed ETTs: The Effect of 3 Different Sizes of cETT on Intracuff Pressure in Children
Not yet recruiting NCT03213548 - Aesthetic and Functional Results of Alar Base Modifications in Rhinoplasty N/A
Completed NCT06164158 - Role of Procedural Videos in Teaching the Surgery Residents N/A
Recruiting NCT03854669 - Experimental Pain Reporting Accuracy and Clinical Post-operative Pain N/A
Active, not recruiting NCT03776591 - Open D3 Right Hemicolectomy Compared to Laparoscopic CME for Right Sided Colon Cancer N/A
Completed NCT04332679 - Non-resorbable Membranes Versus Titanium Meshes and Resorbable Membranes N/A
Completed NCT03305666 - Trial of Injected Liposomal Bupivacaine vs Bupivacaine Infusion After Surgical Stabilization of Rib Fractures Phase 4
Completed NCT05008107 - Virtual Reality as a Perioperative Teaching Tool for Families N/A
Terminated NCT02399111 - A Trial to Evaluate Negative Pressure Incision Management System for Groin Wounds in Vascular Surgery Patients N/A
Terminated NCT00753766 - Multifactorial Pre-operative Intervention in Diabetes Mellitus N/A
Active, not recruiting NCT03684720 - Using 'Guided-Discovery-Learning' to Optimize and Maximize Transfer of Surgical Simulation N/A
Recruiting NCT04134975 - Evaluation of the Contribution of Intraoperative Scans Coupled With the Navigation for the Precision of the Positioning of the Pedicle Screws During a Lumbar Spine Surgery: a Prospective Randomised Study N/A
Completed NCT06148701 - Preoperative Anesthesia Automatic System:a Retrospective Cohort Study
Active, not recruiting NCT04202874 - A Trial Comparing Surgeon-administered TAP Block With Placebo After Midline Laparotomy in Gynecologic Oncology Phase 3
Completed NCT05428579 - Status of Surgical Resection and Histologic Subtype as Predictors of Local Recurrence in Retroperitoneal Liposarcoma
Completed NCT02626546 - Predictors, Risk Factors and Outcome Following Major Surgery
Recruiting NCT06278610 - Pelvic Exenteration and Laterally Extended Pelvic Resection
Recruiting NCT05044832 - Decreasing Emergence Agitation With Personalized Music N/A
Completed NCT04327895 - Surgery in Context of Terrorist Attack : a Survey of French Surgeons