Spinal Versus General Anesthesia on Postoperative Pulmonary Complications

NCT ID: NCT06425627

Last Updated: 2025-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-12

Study Completion Date

2026-05-20

Brief Summary

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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

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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

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Pulmonary Complication Anesthesia Hip Fractures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

spinal anesthesia

Intervention Type PROCEDURE

An intrathecal anesthetic technique.

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.

Group Type EXPERIMENTAL

general anesthesia

Intervention Type PROCEDURE

An intravenous (combined with inhalation) anesthetic technique.

Interventions

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spinal anesthesia

An intrathecal anesthetic technique.

Intervention Type PROCEDURE

general anesthesia

An intravenous (combined with inhalation) anesthetic technique.

Intervention Type PROCEDURE

Other Intervention Names

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lumbar anesthesia

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tongji Hospital

OTHER

Sponsor Role lead

Responsible Party

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Tianzhu Liu

M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tianzhu Liu, M.D.

Role: PRINCIPAL_INVESTIGATOR

Tongji Hospital

Locations

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Tianzhu Liu

Wuhan, Hubei, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Tianzhu Liu, M.D.

Role: CONTACT

13098866448

Facility Contacts

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Tianzhu Liu, M.D.

Role: primary

13098866448

Other Identifiers

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TongjiHospital102114

Identifier Type: -

Identifier Source: org_study_id

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