Main
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
|
ANZCTR |
Last refreshed on:
|
11 June 2018 |
Main ID: |
ACTRN12618000943246 |
Date of registration:
|
04/06/2018 |
Prospective Registration:
|
Yes |
Primary sponsor: |
|
Public title:
|
Comparison of general anesthesia effects in normal weight and fat patients undergoing laparoscopic surgery
|
Scientific title:
|
Comparison of general anesthesia effects in normal weight and obese patients undergoing laparoscopic surgery
|
Date of first enrolment:
|
18/06/2018 |
Target sample size:
|
100 |
Recruitment status: |
Not yet recruiting |
URL:
|
http://www.anzctr.org.au/ACTRN12618000943246.aspx |
Study type:
|
Interventional |
Study design:
|
Randomised controlled trial
Parallel |
Phase:
|
Not Applicable
|
|
Key inclusion & exclusion criteria
|
Health Condition(s) or Problem(s) studied
|
laparoscopic cholecystectomy
|
obesity
|
Intervention(s)
|
All patients will be using the same brand anesthesia device (dräger perseus A500) and the same brand sodalime.
We will perform monitorization (Electrocardiography, SpO2, noninvasive systolic diastolic blood pressure) in our normal routine protocol before the surgery.
2-3 mg / kg propofol, 1-2 µg / kg fentanyl, 0.6 mg / kg rocuronium , 1 mg/kg lidocaine will be administered intravenously during induction of anesthesia. After 2 minutes the patient will be intubated. We will use desflurane as inhaler anesthetic; nitrogen protoxide will not be used.
ARM1: NORMAL WEIGHT, LOW FLOW GROUP. The fresh gas flow will be adjusted to 2 lt/ min (FiO2: 80%), desflurane 12% until the minimum alveolar concentration (MAC) reached to 1 after intubation in normal weight patients (body mass index greater than or equal to 18 and less than 25) . After reaching MAC 1, fresh gas flow will be decreased to 0,5 lt/min and desflurane will be adjusted as MAC 1. FiO2 will continue as 80%. 15 minutes ago before the surgery has finished, we will close desflurane.
ARM2: OBESE, LOW FLOW GROUP. The fresh gas flow will be adjusted to 2 lt/ min (FiO2: 80%), desflurane 12% until the minimum alveolar concentration (MAC) reached to 1 after intubation in obese patients (body mass index greater than or equal to 30) . After reaching MAC 1, fresh gas flow will be decreased to 0,5 lt/min and desflurane will be adjusted as MAC 1. FiO2 will continue as 80%. 15 minutes ago before the surgery has finished, we will close desflurane.
ARM3: NORMAL WEIGHT, HIGH FLOW GROUP. The fresh gas flow will be adjusted to 2 lt/ min (FiO2: 50%), desflurane 12% until the minimum alveolar concentration (MAC) reached to 1 after intubation in normal weight patients. After reaching MAC 1, the fresh gas flow will continue at 2 lt/min (FiO2:50%) and desflurane will be adjusted as MAC 1.
ARM4: OBESE, HIGH FLOW GROUP. The fresh gas flow will be adjusted to 2 lt/ min (FiO2: 50%), desflurane 12% until the minimum alveolar concentration (MAC) reached to 1 after intubation in obese patients. After reaching MAC 1, the fresh gas flow will continue at 2 lt/min (FiO2:50%) and desflurane will be adjusted as MAC 1.
All patients will be followed by an experienced anesthesiologist for at least 4 years.
The mean duration of surgery is 60 minutes.
|
Source(s) of Monetary Support
|
Results
|
Results available:
|
|
Date Posted:
|
|
Date Completed:
|
|
URL:
|
|
|
|