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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05462327
Other study ID # 48670771-514.10/1477
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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.
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