Clinical trial NCT06425627: Spinal Versus General Anesthesia on Postoperative Pulmonary Complications
Official title: Spinal Versus General Anesthesia on Postoperative Pulmonary Complications in Elderly Patients With Delayed Operation of Hip Fracture
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pulmonary Complication
Anesthesia
Hip Fractures
Keywords: Hip fracture
delayed surgery
pulmonary complication
spinal anesthesia
general anesthesia
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2024-05-22
Enrollment: 40
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Arterial partial pressure of oxygen, PaO2
timeFrame: 30 minutes after surgery
Secondary outcomes:
measure: Arterial partial pressure of oxygen, PaO2
timeFrame: 30 minutes before surgery
measure: Forced vital capacity, FVC
timeFrame: 30 minutes before surgery; 30 minutes after surgery; 24 hours after surgery
measure: Forced expiratory volume in 1 second, FEV1
timeFrame: 30 minutes before surgery; 30 minutes after surgery; 24 hours after surgery
measure: Peak expiratory flow, PEF
timeFrame: 30 minutes before surgery; 30 minutes after surgery; 24 hours after surgery
measure: PEF 25, 75, and 25-75
timeFrame: 30 minutes before surgery; 30 minutes after surgery; 24 hours after surgery
measure: Lung Ultrasound Score (LUS)
timeFrame: 30 minutes before surgery, 30 minutes after surgery, 24 hours after surgery
measure: Postoperative pulmonary complications
timeFrame: up to one month
measure: Hip mobility (Harris hip score, HHS)
timeFrame: up to one month
Other outcomes:
measure: Adverse outcomes
timeFrame: up to one month
Locations:
city: Wuhan
country: China
facility: Tianzhu Liu
state: Hubei
Study officials:
affiliation: Tongji Hospital
name: Tianzhu Liu, M.D.
role: PRINCIPAL_INVESTIGATOR
References: