Spinal Versus General Anesthesia on Postoperative Pulmonary Complications

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06425627
• Other study ID #: TongjiHospital102114
• Status: Recruiting
• Phase: N/A
• Start date: May 20, 2024
• Est. completion date: May 20, 2026

Study information

• Verified date: May 2024
• Source: Tongji Hospital
• Contact: Tianzhu Liu, M.D.
• Phone: 13098866448
• Email: liutzh[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: May 20, 2026
• Est. primary completion date: May 20, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

• Chronic obstructive pulmonary disease (COPD), 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

Related Conditions & MeSH terms

• Anesthesia
• Fractures, Bone
• Hip Fractures
• Pulmonary Complication

Intervention

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

Locations

Country	Name	City	State
China	Tianzhu Liu	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Tongji Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse outcomes	Documented side effects associated with the intervention by an unwitting third party	up to one month
Primary	Arterial partial pressure of oxygen, PaO2	PaO2 was measured by arterial blood gas analysis	30 minutes after surgery
Secondary	Arterial partial pressure of oxygen, PaO2	PaO2 was measured by arterial blood gas analysis	30 minutes before surgery
Secondary	Forced vital capacity, FVC	FVC was measured by Spirometer (SP70B)	30 minutes before surgery; 30 minutes after surgery; 24 hours after surgery
Secondary	Forced expiratory volume in 1 second, FEV1	FEV1 was measured by Spirometer (SP70B)	30 minutes before surgery; 30 minutes after surgery; 24 hours after surgery
Secondary	Peak expiratory flow, PEF	PEF was measured by Spirometer (SP70B)	30 minutes before surgery; 30 minutes after surgery; 24 hours after surgery
Secondary	PEF 25, 75, and 25-75	PEF 25, 75, and 25-75 were measured by Spirometer (SP70B)	30 minutes before surgery; 30 minutes after surgery; 24 hours after surgery
Secondary	Lung Ultrasound Score (LUS)	Bedside measurements using portable ultrasound	30 minutes before surgery, 30 minutes after surgery, 24 hours after surgery
Secondary	Postoperative pulmonary complications	Pulmonary complications (PPCs) include: (1) Evidence of pneumonia, pneumothorax, atelectasis and pleural effusion indicated by postoperative pulmonary ultrasound, chest film or chest CT; ? 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; ? 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-1ß, TNF-a).	up to one month
Secondary	Hip mobility (Harris hip score, HHS)	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.	up to one month