NCT05462327

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2020

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

July 6, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 18, 2022

Completed
Last Updated

July 18, 2022

Status Verified

July 1, 2022

Enrollment Period

6 months

First QC Date

July 6, 2022

Last Update Submit

July 14, 2022

Conditions

Keywords

HemodynamicsLow Flow AnesthesiaNear Infrared SpectroscopyProne PositioningRegional Cerebral Oxygenation

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (2)

Low Fresh Gas Flow in Prone Position

EXPERIMENTAL

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

Procedure: Low Fresh Gas Flow in Prone Position

Normal Fresh Gas Flow in Prone Position

ACTIVE COMPARATOR

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

Procedure: Normal Fresh Gas Flow in Prone Position

Interventions

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

Low 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.

Normal Fresh Gas Flow in Prone Position

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • undergoing surgery in the prone position
  • having an American Society of Anesthesiologists (ASA) physical status I to III
  • willingness to participate in the study

You may not qualify if:

  • having a Glasgow coma scale (GSC) score ≤ 12
  • previous history of cranial surgery
  • advanced cardiovascular and/or pulmonary disease
  • mental retardation
  • neurological disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prof. Dr. Cemil Tascioglu City Hospital

Istanbul, Sisli, 34384, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Prone Position

Intervention Hierarchy (Ancestors)

PostureMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

July 6, 2022

First Posted

July 18, 2022

Study Start

October 1, 2019

Primary Completion

March 31, 2020

Study Completion

March 31, 2020

Last Updated

July 18, 2022

Record last verified: 2022-07

Locations