Low Fresh Gas Flow in Prone Position

Not Applicable

Completed

• Conditions: Anesthesia
• Interventions: Procedure: Low Fresh Gas Flow in Prone Position; Procedure: Normal Fresh Gas Flow in Prone Position

• Registration Number: NCT05462327
• Lead Sponsor: Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

Brief 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.

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 Timeline

• Study Start: 2019-10-01
• Primary Completion: 2020-03-31
• Study Completion: 2020-03-31
• Status Verified: 2022-07
• Study First Submitted: 2022-07-06
• Study First Submitted QC: 2022-07-14
• Last Update Submitted: 2022-07-14
• Study First Posted: 2022-07-18
• Last Update Posted: 2022-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low Fresh Gas Flow in Prone Position	Low Fresh Gas Flow in Prone Position	Low fresh gas flow (0,5 L/min during maintenance)
Normal Fresh Gas Flow in Prone Position	Normal Fresh Gas Flow in Prone Position	Normal flow (2 L/min) in general anesthesia.

Primary Outcome Measures

Name	Time	Method
Low and Normal Fresh Gas Flow Difference in Prone Position	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.	Whether low flow anesthesia in the prone position is safe in terms of systemic hemodynamics and cerebral oxygenation compared to normal flow anesthesia

Trial Locations

Locations (1)

Prof. Dr. Cemil Tascioglu City Hospital; 🇹🇷 Istanbul, Sisli, Turkey