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Recruiting NCT06425627

Spinal Versus General Anesthesia on Postoperative Pulmonary Complications

No phase Interventional Pulmonary Complication Anesthesia Hip Fractures

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: spinal anesthesia, general anesthesia.
Who it may be relevant to
Registry conditions: Pulmonary Complication, Anesthesia, Hip Fractures. Basic parameters: from 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Detailed description

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.

Interventions

  • Procedure spinal anesthesia
    An intrathecal anesthetic technique.
  • Procedure general anesthesia
    An intravenous (combined with inhalation) anesthetic technique.

Primary outcome measures

  • Arterial partial pressure of oxygen, PaO2 [Time frame: 30 minutes after surgery]
Secondary outcome measures (8)
  • Arterial partial pressure of oxygen, PaO2 [Time frame: 30 minutes before surgery]
  • Forced vital capacity, FVC [Time frame: 30 minutes before surgery; 30 minutes after surgery; 24 hours after surgery]
  • Forced expiratory volume in 1 second, FEV1 [Time frame: 30 minutes before surgery; 30 minutes after surgery; 24 hours after surgery]
  • Peak expiratory flow, PEF [Time frame: 30 minutes before surgery; 30 minutes after surgery; 24 hours after surgery]
  • PEF 25, 75, and 25-75 [Time frame: 30 minutes before surgery; 30 minutes after surgery; 24 hours after surgery]
  • Lung Ultrasound Score (LUS) [Time frame: 30 minutes before surgery, 30 minutes after surgery, 24 hours after surgery]
  • Postoperative pulmonary complications [Time frame: up to one month]
  • Hip mobility (Harris hip score, HHS) [Time frame: up to one month]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Prevention

Study locations

China · 1 center
  • Tianzhu Liu — Wuhan

Identifiers

NCT: NCT06425627 · TongjiHospital102114

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗