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Spinal Versus General Anesthesia on Postoperative Pulmonary Complications

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06425627
Enrollment
40
Registered
2024-05-22
Start date
2024-06-12
Completion date
2026-05-20
Last updated
2025-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, Hip Fractures, Pulmonary Complication

Keywords

Hip fracture, delayed surgery, pulmonary complication, spinal anesthesia, general anesthesia

Brief summary

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

PROCEDUREspinal anesthesia

An intrathecal anesthetic technique.

PROCEDUREgeneral anesthesia

An intravenous (combined with inhalation) anesthetic technique.

Sponsors

Tongji Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Arterial partial pressure of oxygen, PaO230 minutes after surgeryPaO2 was measured by arterial blood gas analysis

Secondary

MeasureTime frameDescription
Arterial partial pressure of oxygen, PaO230 minutes before surgeryPaO2 was measured by arterial blood gas analysis
Forced vital capacity, FVC30 minutes before surgery; 30 minutes after surgery; 24 hours after surgeryFVC was measured by Spirometer (SP70B)
Forced expiratory volume in 1 second, FEV130 minutes before surgery; 30 minutes after surgery; 24 hours after surgeryFEV1 was measured by Spirometer (SP70B)
Peak expiratory flow, PEF30 minutes before surgery; 30 minutes after surgery; 24 hours after surgeryPEF was measured by Spirometer (SP70B)
Lung Ultrasound Score (LUS)30 minutes before surgery, 30 minutes after surgery, 24 hours after surgeryBedside measurements using portable ultrasound
Postoperative pulmonary complicationsup to one monthPulmonary 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).
Hip mobility (Harris hip score, HHS)up to one monthThe 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.
PEF 25, 75, and 25-7530 minutes before surgery; 30 minutes after surgery; 24 hours after surgeryPEF 25, 75, and 25-75 were measured by Spirometer (SP70B)

Other

MeasureTime frameDescription
Adverse outcomesup to one monthDocumented side effects associated with the intervention by an unwitting third party

Countries

China

Contacts

Primary ContactTianzhu Liu, M.D.
liutzh@126.com13098866448

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026