The Effects of Low Flow and Normal Flow Desflurane Anesthesia

NCT05414721 | Completed

• 1 other identifier: 2021/05-07
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Aging is a physiological process. In the elderly, loss of functional reserve in all organ system, regression in anabolic processes and increase in catabolic processes are observed s (1). The number of geriatric patients is also increasing in our country. Technological developments in anesthesia and surgery technics show that we will provide medical services to more elderly patients over time(2). Cystatin C is excreted only by the kidney (7, 8). Serum cystatin C level is not affected by body muscle mass, age and gender. The half-life is short. Because of all these features, it is thought to be more sensitive than creatinine in evaluating kidney functions (8,9). In this study, it was aimed to compare the effects of low flow and normal flow desflurane anesthesia applied in geriatric patients on postoperative liver and kidney functions and serum cystatin C levels.

Conditions

Anesthesia; Liver Functions; Kidney Functions; Geriatric

Keywords

Low flow desflurane anesthesia,; Liver functions; Kidney functions; Serum cystatin C levels; Geriatric patients.

Outcome Measures

Primary Outcomes (5)

• Alanin Aminotransferaz (ALT)

  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)

  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

  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

  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)

  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 Outcomes (8)

• Heart rate (HR)

  6 hours

• Systolic blood pressure (SBP)

  6 hours

• Diastolic blood pressure (DBP)

  6 hours

• Mean blood pressure (MBP)

  6 hours

• Drug allergies

  24 hours

Study Arms (2)

Low flow desflurane anesthesia (Group D)

ACTIVE COMPARATOR

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.

Drug: Low flow desflurane anesthesia (Group D)

Normal flow desflurane anesthesia (Group N)

NO INTERVENTION

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.

Interventions

Low flow desflurane anesthesia (Group D) DRUG

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.

Also known as: Normal flow desflurane anesthesia (Group N)

Low flow desflurane anesthesia (Group D)

Eligibility Criteria

• Age: 65 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Yuzuncu Yil University: lead

Study Sites (1)

Van Yüzüncü Yıl University, Faculty of Medicine

Van, Tusba, 65080, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 26198766 BACKGROUND

• 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.

  PMID: 9642331 BACKGROUND

• Baum JA, Aitkenhead AR. Low-flow anaesthesia. Anaesthesia. 1995 Oct;50 Suppl:37-44. doi: 10.1111/j.1365-2044.1995.tb06189.x.

  PMID: 7485917 BACKGROUND

Study Officials

• Hacı Yusuf YG Güneş, Assist.prof

  Van Yüzüncü Yıl University Van, Turkey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant proffesor

Model Details: Sixty patients were included in the study. The patients were randomly divided into two groups as low flow anesthesia and normal flow anesthesia. All patients were preoxygenated. Midazolam, fentanyl, propofol and rocuronium were administered iv for induction of anesthesia. After intubation all patients were mechanically ventilated with 50%O2+50% air+7% desflurane in a 4L/min fresh gas flow until the MAC value reached to 1. When the MAC value of desflurane was 1, the fresh gas flow was reduced to 0.5L/min (60%O2+40%air) in GroupD. In GroupN, the fresh gas flow was reduced to 2L/min (40%O2+60% air). The anesthesia was maintained in these fresh gas flows. HR, SBP, DBP, MBP, SpO2 and BIS values were recorded preanesthesia and during surgery. 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.

Study Record Dates

• First Submitted: May 24, 2022
• First Posted: June 10, 2022
• Study Start: May 28, 2021
• Primary Completion: January 28, 2022
• Study Completion: March 30, 2022
• Last Updated: June 10, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 6 months
• Access Criteria: The access can be provided via the e-mail addresses below hyusufgunes@hotmail.com

Locations

TU (1)