Low Fresh Gas Flow in Prone Position

Anesthesia Clinical Trial

Official title:

Low Fresh Gas Flow and Normal Gas Flow Anesthesia in Patients Undergoing Surgery in Prone Position: Impact on Hemodynamics and Regional Cerebral Oxygenation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05462327
• Other study ID #: 48670771-514.10/1477
• Status: Completed
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: March 31, 2020

Study information

• Verified date: July 2022
• Source: Prof. Dr. Cemil Tascioglu Education and Research Hospital Organization
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Low flow anesthesia in the prone position was safe in terms of systemic hemodynamics and did not reduce cerebral oxygenation compared to normal flow.

Description:

Patients were randomly allocated to either low fresh gas flow(LF, 0,5 L/min during maintenance) or normal flow (NF, 2 L/min)) general anesthesia. In both groups, participants were first administered with 100% oxygen at a 4 L/min flow rate. Propofol 2-2,5 mg/kg, rocuronium bromide 0,6 mg/kg, and fentanyl 1 mcg/kg IV were used for anesthesia induction.In the operating room, pulse rate, mean arterial pressure (MAP), peripheral hemoglobin oxygen saturation (spO2), and right and left side regional cerebral oxygen saturation (Masimo's O3 regional oximetry device) were measured before premedication and anesthesia induction, at 10 minutes after endotracheal intubation, at 10 minutes after prone positioning, at 1st, 2nd, 3rd, 4th and 5th hours of operation, before repositioning to supine, after the resumption of supine position and at 5 minutes after extubation. In conclusion, low flow anesthesia in patients undergoing surgery in the prone position did not cause a reduction in cerebral oxygenation compared to normal flow.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: March 31, 2020
• Est. primary completion date: March 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• undergoing surgery in the prone position

• having an American Society of Anesthesiologists (ASA) physical status I to III

• willingness to participate in the study

Exclusion Criteria:

• having a Glasgow coma scale (GSC) score = 12

• previous history of cranial surgery

• advanced cardiovascular and/or pulmonary disease

• mental retardation

• neurological disease

Related Conditions & MeSH terms

• Anesthesia

Intervention

Procedure:
• Low Fresh Gas Flow in Prone Position
In the low fresh gas flow group, the flow rate was reduced to 0.5 L/min
• Normal Fresh Gas Flow in Prone Position
In the normal flow rate group, the gas flow rate was reduced to 2 L/min during the maintenance phase.

Locations

Country	Name	City	State
Turkey	Prof. Dr. Cemil Tascioglu City Hospital	Istanbul	Sisli

Sponsors (1)

Lead Sponsor	Collaborator
Prof. Dr. Cemil Tascioglu Education and Research Hospital Organization

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Low and Normal Fresh Gas Flow Difference in Prone Position	Whether low flow anesthesia in the prone position is safe in terms of systemic hemodynamics and cerebral oxygenation compared to normal flow anesthesia	Systemic and cerebral oxygenation values were measured 10 minutes after induction to general anesthesia and followed up to 10 minutes were left to completion of the surgery for about 5 hours, which may vary according to the duration of the surgery.