Low Fresh Gas Flow in Prone Position

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

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

Study Overview

• Status: Completed
• Conditions: Anesthesia
• Intervention / Treatment: Procedure: Low Fresh Gas Flow in Prone Position; Procedure: Normal Fresh Gas Flow in Prone Position

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Sisli
    • Istanbul, Sisli, Turkey, 34384
      • Prof. Dr. Cemil Tascioglu City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low Fresh Gas Flow in Prone Position; Low fresh gas flow (0,5 L/min during maintenance)	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
Active Comparator: Normal Fresh Gas Flow in Prone Position; Normal flow (2 L/min) in general anesthesia.	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Actual): March 31, 2020
• Study Completion (Actual): March 31, 2020

Study Registration Dates

• First Submitted: July 6, 2022
• First Submitted That Met QC Criteria: July 14, 2022
• First Posted (Actual): July 18, 2022

Study Record Updates

• Last Update Posted (Actual): July 18, 2022
• Last Update Submitted That Met QC Criteria: July 14, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Hemodynamics; Near Infrared Spectroscopy; Low Flow Anesthesia; Prone Positioning; Regional Cerebral Oxygenation
• Other Study ID Numbers: 48670771-514.10/1477

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Patient's sex, ages and additional conditions

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No