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NCT Number: NCT07309575

Regional Versus General Anesthesia for Hip Fracture and Postoperative Oxygenation

With this study, the investigators intend to measure oxygen saturation before and after hip surgery in the context of proximal femur fracture, comparing two types of anesthesia (general or spinal). The investigators also intend to study the effects of the two anesthetic techniques on sleep apnea, delirium, respiratory complications, and length of hospital stay.

This is an observational study, in which oxygen is measured at the fingertip with a sensor and a bracelet, without any intervention, inconvenience, or discomfort for the participant. Data will be collected on: respiratory complications, sleep apnea, delirium, length of hospital stay, and survival.

Data will be collected in the operating room and wards of Santa Maria Hospital, Lisbon, Portugal over a period of approximately 24 hours after the participant's operation. Information about participant's health and co-morbidities will be recorded.

There will be no implication for the participants' clinical care, since the study measurements will not be sent to the health professionals in charge. The operation, recovery, and treatments will not be influenced at any time by participation in the study.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Northern Lisbon Hospital Center

Lisbon, Lisbon District, 1635, Portugal

Location status: Recruiting

Location contact

Andre dos Santos Rocha, MD, PhD

CONTACT

[email protected]

+351 969 345 052

About this study

Frailty, comorbidities, medication (anticoagulants and anti-platellet agents) as well as acute and chronic illnesses have an impact on the choice of anesthesia strategy for hip fracture surgery. The choice between general anesthesia (GA) and loco-regional, spinal anesthesia (SA) may have impact on the postoperative period. Despite previous retrospective studies on this topic, it remains uncertain that either is superior in terms of post-operative outcomes, including mortality, delirium and respiratory complications, with conflicting results in the literature.

Postoperative pulmonary complications (PPC) are amongst the commonest complications in geriatric hip fractures, reported to be around 12%. The elder population at Hospital de Santa Maria (Tertiary University Hospital Center) receives the most challenging cases, with pilot data from the past 3 years (2022-2024, n=927) revealing an average risk score for PPC of 32,1%.

Considering that low oxygen saturation is an independent risk factor and a strong predictor for PPC, the investigators seek to compare the oxygenation during the perioperative period between the different anesthesia regimens.

The study hypothesis is that the anesthesia regimen (GA vs SA) has an impact on the oxygenation index during the first 24 postoperative hours.

The secondary objectives are to compare the sleep apnea index between GA and SA, the incidence of PPC, delirium, mortality and the length of stay (LOS) in the PACU and until discharge from the hospital.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • hospital admission for hip fracture;
  • scheduled for hip fracture surgery;
  • age above 65 years, both genders;
  • capable of consent or consent by responsible person;

Exclusion criteria

  • hip fracture during hospitalization (not present upon admission)
  • patient refusal to participate

Treatment and study plan

Primary outcomes

  1. Oxygenation index (SpO2/FiO2 ratio)

    Time frame: first postoperative day

    Oxygenation index (SpO2/FiO2 ratio) measured as the difference between oxygenation index on admission to the operating room and the mean SpO2 during the next 24 postoperative hours, compared between groups.

    Peripheral oxygen saturation measured continuously during the first postoperative day with the Konica Minolta PULSOX-DS5® device.

Secondary outcomes

  1. Sleep Apnea index

    Time frame: first postoperative day

    average dips of SpO2 per hour, (>= 4%)

  2. Length of stay in the Post-anestesia Care Unit

    Time frame: after the surgery, at discharge from the Post-anestesia Care Unit

    Length of stay in the Post-anestesia Care Unit

  3. Hospital Length of Stay (Days)

    Time frame: from hospital admission to hospital discharge, approximatelly 5 days

    Length of stay in the hospital from admission until discharge, in days

  4. postoperative pulmonary complications

    Time frame: during the first postoperative day

    postoperative pulmonary complications defined as hypoxemia, respiratory failure, atelectasis, pneumothorax, respiratory infection.

  5. Delirium

    Time frame: during the first postoperative day

    Presence of delirium in the first postoperative day

  6. in-Hospital mortality

    Time frame: From hospital admission to hospital discharge (or death), up to 3 months

    death from any cause during hospital stay, from hospital admission to discharge

Sponsors and collaborators

Lead sponsor

University of Lisbon

Other

Collaborators

  • Northern Lisbon Hospital Center

Registry information

Acronym: REGENERATION

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 30, 2025
Registry last updated
Dec 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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