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NCT Number: NCT06425627

Spinal Versus General Anesthesia on Postoperative Pulmonary Complications

The objective of this study was to investigate the difference in postoperative pulmonary complications (PPCs) between spinal anesthesia and general anesthesia in patients undergoing delayed hip surgery.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tianzhu Liu

Wuhan, Hubei, 430000, China

Location status: Recruiting

Location contact

Tianzhu Liu, M.D.

CONTACT

[email protected]

13098866448

Tianzhu Liu, M.D.

PRINCIPAL_INVESTIGATOR

About this study

In this study, the difference of 30 min arterial partial pressure of oxygen after operation was used as the main outcome index. By means of pulmonary ultrasound, pulmonary function monitoring and other physical and biochemical examinations, the difference of postoperative pulmonary complications between spinal anesthesia and general anesthesia in patients with delayed operation of hip fracture longer than 48 hours was compared.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients ≥ 65 years old
  • ASA Class I ~ III
  • Surgical repair of femoral neck, intertrochanteric or subtrochanteric fractures
  • The time from diagnosis to surgery is more than 48 hours

Exclusion criteria

  • Unable to walk about 3 meters or across a room without assistance before the fracture
  • Emergency surgery
  • Congestive heart failure, asthma, anemia (Hb < 90 g/L), hypoalbuminemia (ALB < 35g/L)
  • Abnormal coagulation function
  • Severe aortic stenosis
  • Injection site infection or increased intracranial pressure
  • Patients have participated in previous trials or have been determined by a surgeon or anesthesiologist to be unsuitable for randomization
  • The written informed consent of the patient or his/her representative cannot be obtained

Treatment and study plan

Spinal anesthesia

Procedure

An intrathecal anesthetic technique.

Other names: lumbar anesthesia

General Anesthesia

Procedure

An intravenous (combined with inhalation) anesthetic technique.

Primary outcomes

  1. Arterial partial pressure of oxygen, PaO2

    Time frame: 30 minutes after surgery

    PaO2 was measured by arterial blood gas analysis

Secondary outcomes

  1. Arterial partial pressure of oxygen, PaO2

    Time frame: 30 minutes before surgery

    PaO2 was measured by arterial blood gas analysis

  2. Forced vital capacity, FVC

    Time frame: 30 minutes before surgery; 30 minutes after surgery; 24 hours after surgery

    FVC was measured by Spirometer (SP70B)

  3. Forced expiratory volume in 1 second, FEV1

    Time frame: 30 minutes before surgery; 30 minutes after surgery; 24 hours after surgery

    FEV1 was measured by Spirometer (SP70B)

  4. Peak expiratory flow, PEF

    Time frame: 30 minutes before surgery; 30 minutes after surgery; 24 hours after surgery

    PEF was measured by Spirometer (SP70B)

  5. PEF 25, 75, and 25-75

    Time frame: 30 minutes before surgery; 30 minutes after surgery; 24 hours after surgery

    PEF 25, 75, and 25-75 were measured by Spirometer (SP70B)

  6. Lung Ultrasound Score (LUS)

    Time frame: 30 minutes before surgery, 30 minutes after surgery, 24 hours after surgery

    Bedside measurements using portable ultrasound

  7. Postoperative pulmonary complications

    Time frame: up to one month

    Pulmonary complications (PPCs) include: (1) Evidence of pneumonia, pneumothorax, atelectasis and pleural effusion indicated by postoperative pulmonary ultrasound, chest film or chest CT; ② After surgery, the patient developed bronchospasm, ARDS, O2 requirement (nasal catheter or mask), non-invasive ventilation requirement, or unplanned endotracheal intubation/mechanical ventilation for more than 1 day; ③ The increase of inflammatory biochemical indexes 24 h after surgery suggested systemic inflammatory response (blood routine, C-reactive protein CRP, procalcitonin PCT and IL-6, IL-1β, TNF-α).

  8. Hip mobility (Harris hip score, HHS)

    Time frame: up to one month

    The Harris scale was used to score. Range:0-100. A total Harris hip score below 70 points was considered a poor result, 70 to 80 fair, 80 to 90 good, and 90 to 100 excellent.

Other outcomes

  1. Adverse outcomes

    Time frame: up to one month

    Documented side effects associated with the intervention by an unwitting third party

Study contacts

Contact information is provided by the study sponsor or research team.

Tianzhu Liu, M.D.

CONTACT

[email protected]

13098866448

Sponsors and collaborators

Lead sponsor

Tongji Hospital

Other

Registry information

Official study title

Spinal Versus General Anesthesia on Postoperative Pulmonary Complications in Elderly Patients With Delayed Operation of Hip Fracture

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 22, 2024
Registry last updated
Sep 17, 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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