- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05414721
The Effects of Low Flow and Normal Flow Desflurane Anesthesia
The Effects of Low Flow and Normal Flow Desflurane Anesthesia on Postoperative Liver and Renal Functions and Serum Cystatin C Levels in Geriatric Patients: A Prospective Randomized Controlled Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This prospective, randomized-controlled, observational study was approved by the ethics committee of Van Yuzuncu Yıl University (Date: 16.04.2021, Decision no: 05-27). The study was performed according to the World Medical Association's Declaration of Helsinki. All enrolled patients provided written informed consent.
In this prospective study; the patients were randomly divided into 2 groups according to the fresh gas flow applied. 'Group D' (n=30) was given to the low flow anesthesia group; the group in which normal flow anesthesia was administered was named 'Group N' (n=30).
Before anesthesia, automatic calibration of the anesthesia device (Primus, Drager) and leak tests were performed. In addition, the leak test was repeated manually for each patient. Alarm limits of the anesthesia device; The lower limit of inspired oxygen concentration (FiO2) was set to 30%, upper limit of inspired CO2 to 3%, and upper limit of end-tidal carbon dioxide (etCO2) to 45 mmHg.
The disconnection alarm was set to be 5 cmH2O lower than the peak pressure, the occlusion alarm was set to 30 cmH2O, the lower expiratory gas volume lower limit was set to be 500 mL below the desired minute volume (MV).
Soda lime (Sorbo-lime, Berkim, Turkey) was used as carbon dioxide absorbent. Soda lime was checked frequently for color and changed at appropriate times. Disposable anesthesia circuit and bacterial filter were used for each case.
Electrocardiography (ECG), peak heart rate (CTA), peripheral oxygen saturation (SpO2), non-invasive blood pressure and bispectral index (BIS) monitorisation (A-2000 Aspect medical systems, USA) were performed on all patien.
As a standard, vascular access was established with a 20-gauge (G) intraket from the dorsal of the hand or antecubital fossa in each patient and, a balanced electrolyte solution was infused of 8-10 ml/kg/hr.
All patients were preoxygenated with 100% O₂ for three minutes. For anesthesia induction, 0.03 mg/kg midazolam, 1-1.5 mcg/kg fentanyl, 2 mg/kg propofol and 0.6 mg/kg rocuronium were administered iv. Intubation was performed after adequate muscle relaxation was achieved. During mechanical ventilation; Tidal volume, PEEP, respiratory rate, etCO₂, and inspiration:expiration ratio were adjusted to be 7-10 ml/kg, 5 cmH2O, 12-14/min, 30-40 mmHg, 1:2 respectively.
Both groups were given a mixture of 50% O2 + 50% air + 6-7% desflurane in a 4 L/min fresh gas flow (FGF) until the minimum alveolar concentration (MAC) value was 1.
When the MAC value of desflurane was 1, FGF was reduced to 0.5 L/min (60% O2+40% dry air+8% desflurane) in Group D. In Group N, anesthesia was maintained by reducing FGF to 2 liters per minute (40% O2+60% air+6% desflurane). It was aimed to keep the MAC value between 0.9-1.1 and BIS values between 40-60 by titration of desflurane in all patients. Hemodynamic data, SpO2 and BIS values of the patients were recorded. It was recorded before induction, after induction, when switching to low/normal flow anesthesia, and during extubation.
Venous blood samples were obtained before induction, after surgery, and at the postoperative 24th hour to evaluate liver and kidney functions.
The SPSS 27.0 program was used to evaluate the data obtained in this study. In the descriptive statistics of the data, mean, standard deviation, median minimum, maximum, frequency and ratio values were used. The distribution of variables was measured with the Kolmogorov-Smirnov test. The mann-whitney u test was used in the analysis of quantitative independent data. Wilcoxon test was used in the analysis of dependent quantitative data. Chi-square test was used in the analysis of qualitative independent data, and the fischer test was used when the chi-square test conditions were not met. Statistical significance value was accepted as p<0.05 in all tests.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Tusba
-
Van, Tusba, Turkey, 65080
- Van Yüzüncü Yıl University, Faculty of Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients with an American Society of Anesthesiologists (ASA) status of class I-III,
- Aged between 65 and 100 years,
- Scheduled to undergo general anesthesia and, the surgeries that will take longer than 1 hour.
Exclusion Criteria:
- ASA class ≥ III patients
- Thorasic surgery
- Neurosurgery
- Cardiorespiratory disease,
- Uncontrolled diabetes mellitus,
- Coagulation disorders,
- Preoperative liver and renal dysfunction,
- History of malignant hyperthermia,
- Using nephrotoxic or hepatotoxic drugs,
- Major bleeding (>1000 cc) is predicted in the operation,
- Chronic alcoholism,
- Patients with drug use or withdrawal symptoms
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Low flow desflurane anesthesia (Group D)
All patients were preoxygenated for three minutes.
Midazolam 0.03 mg/kg, fentanyl 1.5 mcg/kg , propofol 2 mg/kg and rocuronium 0.6 mg/kg were administered iv for induction of anesthesia.
After intubation all patients were mechanically ventilated with 50% O2+50% air + 6-7% desflurane in a 4 L/min fresh gas flow until the MAC value reached 1.
When the MAC value of desflurane was 1, fresh gas flow was decreased to 0.5 L/min (60% O2+40% air) in Group D. Hemodynamic parameters, SpO2 and BIS values were recorded after induction, at the beginning of low flow/normal flow anesthesia and every 5 minutes during surgery.
The patients were observed in terms of side effects and complications during the operation and in the postoperative period.
To research the liver and the kidney functions, blood samples were taken pre-induction, post-surgery, and at the postoperative 24th hour by venous route.
|
When the MAC value of desflurane was 1, fresh gas flow was decreased to 0.5 L/min (60% O2+40% air).
Hemodynamic parameters, SpO2 and BIS values were recorded after induction, at the beginning of low flow/normal flow anesthesia and every 5 minutes during surgery.
The patients were observed in terms of side effects and complications during the operation and in the postoperative period.
To research the liver and the kidney functions, blood samples were taken pre-induction, post-surgery, and at the postoperative 24th hour by venous route.
Other Names:
|
No Intervention: Normal flow desflurane anesthesia (Group N)
All patients were preoxygenated for three minutes.
Midazolam 0.03 mg/kg, fentanyl 1.5 mcg/kg , propofol 2 mg/kg and rocuronium 0.6 mg/kg were administered iv for induction of anesthesia.
After intubation all patients were mechanically ventilated with 50% O2+50% air + 6-7% desflurane in a 4 L/min fresh gas flow until the MAC value reached 1.
When the MAC value of desflurane was 1, fresh gas flow was decreased to 2 L/min (40% O2+60% air) in Group N. Hemodynamic parameters, SpO2 and BIS values were recorded after induction, at the beginning of low flow/normal flow anesthesia and every 5 minutes during surgery.
The patients were observed in terms of side effects and complications during the operation and in the postoperative period.
To research the liver and the kidney functions, blood samples were taken pre-induction, post-surgery, and at the postoperative 24th hour by venous route.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Alanin Aminotransferaz (ALT)
Time Frame: 24 hours
|
To research the serum alanin Aminotransferaz (ALT) , blood samples were taken pre-induction, post-surgery, and at the postoperative 24th hour by venous route.
|
24 hours
|
Aspartat Aminotransferaz (AST)
Time Frame: 24 hours
|
To research the serum Aspartat Aminotransferaz (AST) , blood samples were taken pre-induction, post-surgery, and at the postoperative 24th hour by venous route.
|
24 hours
|
Serum creatinine
Time Frame: 24 hours
|
To research the serum creatinine , blood samples were taken pre-induction, post-surgery, and at the postoperative 24th hour by venous route.
|
24 hours
|
Serum cystatin C
Time Frame: 24 hours
|
To research the Serum cystatin C , blood samples were taken pre-induction, post-surgery, and at the postoperative 24th hour by venous route.
|
24 hours
|
Blood urea nitrogen (BUN)
Time Frame: 24 hours
|
To research the Blood urea nitrogen (BUN) , blood samples were taken pre-induction, post-surgery, and at the postoperative 24th hour by venous route.
|
24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Heart rate (HR)
Time Frame: 6 hours
|
HR were recorded before anesthesia induction and during surgery.
|
6 hours
|
Systolic blood pressure (SBP)
Time Frame: 6 hours
|
SBP were recorded before anesthesia induction and during surgery.
|
6 hours
|
Diastolic blood pressure (DBP)
Time Frame: 6 hours
|
DBP were recorded before anesthesia induction and during surgery.
|
6 hours
|
Mean blood pressure (MBP)
Time Frame: 6 hours
|
MBP were recorded before anesthesia induction and during surgery.
|
6 hours
|
Drug allergies
Time Frame: 24 hours
|
The patients were observed in terms of drug allergies, during the operation and in the postoperative period.
|
24 hours
|
Nausea-vomiting
Time Frame: 24 hours
|
The patients were observed in terms of nausea-vomiting during the operation and in the postoperative period.
|
24 hours
|
Shivering and agitation
Time Frame: 24 hours
|
The patients were observed in terms of shivering and agitation during the operation and in the postoperative period.
|
24 hours
|
İnsufficient depth of anesthesia
Time Frame: During surgery
|
The patients were monitored with BİS monitorization for complications such as nsufficient depth of anesthesia
|
During surgery
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Hacı Yusuf YG Güneş, Assist.prof, Van Yüzüncü Yıl University Van, Turkey
Publications and helpful links
General Publications
- Horwitz M, Jakobsson JG. Desflurane and sevoflurane use during low- and minimal-flow anesthesia at fixed vaporizer settings. Minerva Anestesiol. 2016 Feb;82(2):180-5. Epub 2015 Jul 22.
- Xie G, Jiang H. Clinical study of desflurane on low flow anesthesia compared with sevoflurane and enflurane. Chin Med J (Engl). 1997 Sep;110(9):707-10.
- Baum JA, Aitkenhead AR. Low-flow anaesthesia. Anaesthesia. 1995 Oct;50 Suppl:37-44. doi: 10.1111/j.1365-2044.1995.tb06189.x.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021/05-07
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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