None listed
Conditions
Brief summary
Indocyanine green has been used in laparoscopic cholecystectomies for several years now to improve the visualization of patients’ extrahepatic biliary anatomy. Various doses and timings of indocyanine green have been used to improve visualization while reducing liver hyper fluorescence, with no optimization of either. The purpose of this study is to find an optimal dose and time to administer indocyanine green in laparoscopic cholecystectomies which are currently mostly conducted as day cases at St. Vincent’s Hospital in Melbourne, Australia. The primary hypothesis is that a lower dose of ICG administered within an hour of surgery provides better visualization of the extrahepatic biliary anatomy compared to the commonly-used higher dose.
Interventions
Dose and timing of indocyanine green (ICG) administered intravenously by the anaesthetist and noted on the study case report form.
Arm 1: 1.25mg of ICG administered 30 to 60 minutes prior to surgery
Arm 2: 1.25mg of ICG administered more than 120 minutes before surgery
Arm 3: 2.5mg of ICG administered 30 to 60 minutes prior to surgery
Arm 4: 2.5mg of ICG administered more than 120 minutes before surgery
There is no limit to the maximum amount of time before surgery. This time will be noted
Dose and timing of indocyanine green (ICG) administered intravenously by the anaesthetist and noted on the study case report form. Arm 1: 1.25mg of ICG administered 30 to 60 minutes prior to surgery Arm 2: 1.25mg of ICG administered more than 120 minutes before surgery Arm 3: 2.5mg of ICG administered 30 to 60 minutes prior to surgery Arm 4: 2.5mg of ICG administered more than 120 minutes before surgery There is no limit to the maximum amount of time before surgery. This time will be noted in the case report form.
Sponsors
Brett Knowles, St Vincent's Hospital Melbourne
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Age 18 years and above • Requiring laparoscopic cholecystectomy for benign indications including cholecystitis, symptomatic cholelithiasis and others • Able to understand English • Able to give an informed consent
Exclusion criteria
• Age below 18 years • Pregnancy or lactation • Malignancy • Requiring cholecystectomy after hours • Liver and renal derangement • Previous adverse reaction to indocyanine green or iodinated contrast
Outcome results
None listed