Low Fresh Gas Flow in Prone Position

NCT ID: NCT05462327

Last Updated: 2022-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-01

Study Completion Date

2020-03-31

Brief Summary

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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

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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.

Conditions

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Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Low Fresh Gas Flow in Prone Position

Low fresh gas flow (0,5 L/min during maintenance)

Group Type EXPERIMENTAL

Low Fresh Gas Flow in Prone Position

Intervention Type PROCEDURE

In the low fresh gas flow group, the flow rate was reduced to 0.5 L/min

Normal Fresh Gas Flow in Prone Position

Normal flow (2 L/min) in general anesthesia.

Group Type ACTIVE_COMPARATOR

Normal Fresh Gas Flow in Prone Position

Intervention Type PROCEDURE

In the normal flow rate group, the gas flow rate was reduced to 2 L/min during the maintenance phase.

Interventions

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Low Fresh Gas Flow in Prone Position

In the low fresh gas flow group, the flow rate was reduced to 0.5 L/min

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

OTHER

Sponsor Role lead

Responsible Party

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Esra Akdaş Tekin

Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Prof. Dr. Cemil Tascioglu City Hospital

Istanbul, Sisli, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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48670771-514.10/1477

Identifier Type: -

Identifier Source: org_study_id

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