NCT06636448

Brief Summary

This study was designed as a prospective observational study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2024

Shorter than P25 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 27, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 10, 2024

Completed
22 days until next milestone

Study Start

First participant enrolled

November 1, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2025

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

August 13, 2025

Status Verified

September 1, 2024

Enrollment Period

3 months

First QC Date

September 27, 2024

Last Update Submit

August 12, 2025

Conditions

Keywords

major gynecological cancer surgerylow flow aneshesiacerebral oxygenationhypoxia

Outcome Measures

Primary Outcomes (1)

  • postoperative hospital stay

    The primary aim of this study was to evaluate the duration of postoperative hospital stay

    up to 10 days postoperative

Other Outcomes (1)

  • Intraoperative cerebral oxygenation

    intraoperative process

Study Arms (1)

obese patients undergoing low-flow anaesthesia

Low-flow anaesthesia was performed in patients with a body mass index between 30-40

Procedure: the effect of body mass index during low-flow anesthesia

Interventions

The investigator planned to evaluate the effect of body mass index on patient outcomes during low-flow anesthesia in patients undergoing gynecologic cancer surgery.

obese patients undergoing low-flow anaesthesia

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

A total of 40 patients were planned for this study

You may qualify if:

  • Patients with ASA II-III
  • \>18 years
  • Patients undergoing major open surgery for endometrium, cervix or ovarian ca in gynaecological oncology clinic

You may not qualify if:

  • Patients who refused to participate in the study
  • Cerebrovascular disease
  • Those with severe pulmonary disease
  • Those with serious cardiovascular disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duygu

Istanbul, Turkey (Türkiye)

Location

Related Publications (3)

  • Mychaskiw G 2nd. Low and minimal flow anesthesia: Angels dancing on the point of a needle. J Anaesthesiol Clin Pharmacol. 2012 Oct;28(4):423-5. doi: 10.4103/0970-9185.101883. No abstract available.

    PMID: 23225917BACKGROUND
  • Oterkus M, Donmez I, Nadir AH, Rencuzogullari I, Karabag Y, Binnetoglu K. The effect of low flow anesthesia on hemodynamic and peripheral oxygenation parameters in obesity surgery. Saudi Med J. 2021 Mar;42(3):264-269. doi: 10.15537/smj.2021.42.3.20200575.

    PMID: 33632904BACKGROUND
  • Akbas S, Ozkan AS. Comparison of effects of low-flow and normal-flow anesthesia on cerebral oxygenation and bispectral index in morbidly obese patients undergoing laparoscopic sleeve gastrectomy: a prospective, randomized clinical trial. Wideochir Inne Tech Maloinwazyjne. 2019 Jan;14(1):19-26. doi: 10.5114/wiitm.2018.77265. Epub 2018 Jul 24.

    PMID: 30766625BACKGROUND

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

September 27, 2024

First Posted

October 10, 2024

Study Start

November 1, 2024

Primary Completion

February 1, 2025

Study Completion

March 1, 2025

Last Updated

August 13, 2025

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations