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

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.

Study Overview

• Status: Recruiting
• Conditions: Hip Fractures; Anesthesia; Pulmonary Complication
• Intervention / Treatment: Procedure: spinal anesthesia; Procedure: general anesthesia

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tianzhu Liu, M.D.; Phone Number: 13098866448; Email: liutzh@126.com

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430000
      • Recruiting
      • Tianzhu Liu
      • Contact: Tianzhu Liu, M.D.; Phone Number: 13098866448; Email: liutzh@126.com
      • Principal Investigator: Tianzhu Liu, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: spinal anesthesia; Patients underwent real-time ultrasound guided spinal anesthesia. The maximum attempts of skin piercings are 3, and the total redirections of each skin piercings should not exceed 6 times. General anesthesia was considered if three skin piercings were unsuccessful.	Procedure: spinal anesthesia; An intrathecal anesthetic technique.; Other Names: lumbar anesthesia
Experimental: general anesthesia; Rapid sequential induction was performed with sufentanil 0.5 ug /kg, etomidate 0.3 mg /kg, cisatracurium 0.15 mg /kg, and then laryngeal mask was applyed. Parameter settings: tidal volume: 6-10 mL/kg, 1.5 ~ 2.0% sevoflurane inhalation, remifentanil 0.1 ~ 0.2 ug/ kg.min-1. Mechanical driving pressure was applyed by PEEP titration method.	Procedure: general anesthesia; An intravenous (combined with inhalation) anesthetic technique.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Arterial partial pressure of oxygen, PaO2	PaO2 was measured by arterial blood gas analysis	30 minutes after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Arterial partial pressure of oxygen, PaO2	PaO2 was measured by arterial blood gas analysis	30 minutes before surgery
Forced vital capacity, FVC	FVC was measured by Spirometer (SP70B)	30 minutes before surgery; 30 minutes after surgery; 24 hours after surgery
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
Peak expiratory flow, PEF	PEF was measured by Spirometer (SP70B)	30 minutes before surgery; 30 minutes after surgery; 24 hours after surgery
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
Lung Ultrasound Score (LUS)	Bedside measurements using portable ultrasound	30 minutes before surgery, 30 minutes after surgery, 24 hours after surgery
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; 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).	up to one month
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse outcomes	Documented side effects associated with the intervention by an unwitting third party	up to one month

Collaborators and Investigators

• Sponsor: Tongji Hospital
• Investigators: Principal Investigator: Tianzhu Liu, M.D., Tongji Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): May 20, 2024
• Primary Completion (Estimated): May 20, 2025
• Study Completion (Estimated): May 20, 2026

Study Registration Dates

• First Submitted: May 9, 2024
• First Submitted That Met QC Criteria: May 17, 2024
• First Posted (Actual): May 22, 2024

Study Record Updates

• Last Update Posted (Actual): May 23, 2024
• Last Update Submitted That Met QC Criteria: May 22, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: general anesthesia; spinal anesthesia; Hip fracture; pulmonary complication; delayed surgery
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Fractures, Bone; Hip Fractures; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: TongjiHospital102114

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No