## Protocol Section
### Identification Module
**NCT ID:** NCT06425627

**Brief Title:** 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

#### Organization Study ID Info
**ID:** TongjiHospital102114
#### Organization
**Class:** OTHER
**Full Name:** Tongji Hospital
### Status Module
#### Completion Date
**Date:** 2026-05-20

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-23

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-22

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-05-20

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-20

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-09
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Tongji Hospital

#### Responsible Party

**Investigator Affiliation:** Tongji Hospital

**Investigator Full Name:** Tianzhu Liu

**Investigator Title:** M.D.

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Pulmonary Complication

- Anesthesia

- Hip Fractures

**Keywords:**

- Hip fracture

- delayed surgery

- pulmonary complication

- spinal anesthesia

- general anesthesia

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- OUTCOMES_ASSESSOR

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 40

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Procedure: spinal anesthesia

**Label:** spinal anesthesia

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** 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.

**Intervention Names:**

- Procedure: general anesthesia

**Label:** general anesthesia

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- spinal anesthesia

**Description:** An intrathecal anesthetic technique.

**Name:** spinal anesthesia

**Other Names:**

- lumbar anesthesia

**Type:** PROCEDURE

#### Intervention 2

**Arm Group Labels:**

- general anesthesia

**Description:** An intravenous (combined with inhalation) anesthetic technique.

**Name:** general anesthesia

**Type:** PROCEDURE

### Outcomes Module

#### Other Outcomes

**Description:** Documented side effects associated with the intervention by an unwitting third party

**Measure:** Adverse outcomes

**Time Frame:** up to one month

#### Primary Outcomes

**Description:** PaO2 was measured by arterial blood gas analysis

**Measure:** Arterial partial pressure of oxygen, PaO2

**Time Frame:** 30 minutes after surgery

#### Secondary Outcomes

**Description:** PaO2 was measured by arterial blood gas analysis

**Measure:** Arterial partial pressure of oxygen, PaO2

**Time Frame:** 30 minutes before surgery

**Description:** FVC was measured by Spirometer (SP70B)

**Measure:** Forced vital capacity, FVC

**Time Frame:** 30 minutes before surgery; 30 minutes after surgery; 24 hours after surgery

**Description:** FEV1 was measured by Spirometer (SP70B)

**Measure:** Forced expiratory volume in 1 second, FEV1

**Time Frame:** 30 minutes before surgery; 30 minutes after surgery; 24 hours after surgery

**Description:** PEF was measured by Spirometer (SP70B)

**Measure:** Peak expiratory flow, PEF

**Time Frame:** 30 minutes before surgery; 30 minutes after surgery; 24 hours after surgery

**Description:** PEF 25, 75, and 25-75 were measured by Spirometer (SP70B)

**Measure:** PEF 25, 75, and 25-75

**Time Frame:** 30 minutes before surgery; 30 minutes after surgery; 24 hours after surgery

**Description:** Bedside measurements using portable ultrasound

**Measure:** Lung Ultrasound Score (LUS)

**Time Frame:** 30 minutes before surgery, 30 minutes after surgery, 24 hours after surgery

**Description:** 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).

**Measure:** Postoperative pulmonary complications

**Time Frame:** up to one month

**Description:** 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.

**Measure:** Hip mobility (Harris hip score, HHS)

**Time Frame:** up to one month

### Eligibility Module

**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
* 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

**Minimum Age:** 65 Years

**Sex:** ALL

**Standard Ages:**

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** liutzh@126.com

**Name:** Tianzhu Liu, M.D.

**Phone:** 13098866448

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Wuhan

**Contacts:**

***Contact 1:***

- **Email:** liutzh@126.com

- **Name:** Tianzhu Liu, M.D.

- **Phone:** 13098866448

- **Role:** CONTACT

***Contact 2:***

- **Name:** Tianzhu Liu, M.D.

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** China

**Facility:** Tianzhu Liu

**State:** Hubei

**Status:** RECRUITING

**Zip:** 430000

#### Overall Officials

**Official 1:**

**Affiliation:** Tongji Hospital

**Name:** Tianzhu Liu, M.D.

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000014947

- Term: Wounds and Injuries

- ID: D000005264

- Term: Femoral Fractures

- ID: D000025981

- Term: Hip Injuries

- ID: D000007869

- Term: Leg Injuries

### Condition Browse Module - Browse Branches

- Abbrev: BC26

- Name: Wounds and Injuries

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M26370

- Name: Fractures, Bone

- Relevance: HIGH

- As Found: Fracture

- ID: M9696

- Name: Hip Fractures

- Relevance: HIGH

- As Found: Hip Fracture

- ID: M17685

- Name: Wounds and Injuries

- Relevance: LOW

- As Found: Unknown

- ID: M8402

- Name: Femoral Fractures

- Relevance: LOW

- As Found: Unknown

- ID: M23105

- Name: Hip Injuries

- Relevance: LOW

- As Found: Unknown

- ID: M10881

- Name: Leg Injuries

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000050723

- Term: Fractures, Bone

- ID: D000006620

- Term: Hip Fractures

### Intervention Browse Module - Ancestors

- ID: D000002492

- Term: Central Nervous System Depressants

- ID: D000045505

- Term: Physiological Effects of Drugs

### Intervention Browse Module - Browse Branches

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: PlAggInh

- Name: Platelet Aggregation Inhibitors

- Abbrev: AdjAn

- Name: Adjuvants, Anesthesia

- Abbrev: Analg

- Name: Analgesics

### Intervention Browse Module - Browse Leaves

- ID: M4107

- Name: Anesthetics

- Relevance: HIGH

- As Found: Imaging

- ID: M1673

- Name: Sevoflurane

- Relevance: LOW

- As Found: Unknown

- ID: M19684

- Name: Sufentanil

- Relevance: LOW

- As Found: Unknown

- ID: M1696

- Name: Remifentanil

- Relevance: LOW

- As Found: Unknown

- ID: M237638

- Name: Cisatracurium

- Relevance: LOW

- As Found: Unknown

- ID: M8190

- Name: Etomidate

- Relevance: LOW

- As Found: Unknown

- ID: M117729

- Name: Dsuvia

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000000777

- Term: Anesthetics

### Misc Info Module

- Version Holder: 2024-05-31
