NCT06425627

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
1mo left

Started Jun 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress98%
Jun 2024May 2026

First Submitted

Initial submission to the registry

May 9, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 22, 2024

Completed
21 days until next milestone

Study Start

First participant enrolled

June 12, 2024

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2026

Last Updated

September 17, 2025

Status Verified

September 1, 2025

Enrollment Period

1.9 years

First QC Date

May 9, 2024

Last Update Submit

September 11, 2025

Conditions

Pulmonary ComplicationAnesthesiaHip Fractures

Keywords

Hip fracturedelayed surgerypulmonary complicationspinal anesthesiageneral anesthesia

Outcome Measures

Primary Outcomes (1)

  • Arterial partial pressure of oxygen, PaO2

    PaO2 was measured by arterial blood gas analysis

    30 minutes after surgery

Secondary Outcomes (8)

  • Arterial partial pressure of oxygen, PaO2

    30 minutes before surgery

  • Forced vital capacity, FVC

    30 minutes before surgery; 30 minutes after surgery; 24 hours after surgery

  • Forced expiratory volume in 1 second, FEV1

    30 minutes before surgery; 30 minutes after surgery; 24 hours after surgery

  • Peak expiratory flow, PEF

    30 minutes before surgery; 30 minutes after surgery; 24 hours after surgery

  • PEF 25, 75, and 25-75

    30 minutes before surgery; 30 minutes after surgery; 24 hours after surgery

  • +3 more secondary outcomes

Other Outcomes (1)

  • Adverse outcomes

    up to one month

Study Arms (2)

spinal anesthesia

EXPERIMENTAL

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

general anesthesia

EXPERIMENTAL

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

Interventions

spinal anesthesiaPROCEDURE

An intrathecal anesthetic technique.

Also known as: lumbar anesthesia
spinal anesthesia
general anesthesiaPROCEDURE

An intravenous (combined with inhalation) anesthetic technique.

general anesthesia

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tianzhu Liu

Wuhan, Hubei, 430000, China

RECRUITING

MeSH Terms

Conditions

Hip Fractures

Interventions

Anesthesia, SpinalAnesthesia, General

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and Analgesia

Study Officials

  • Tianzhu Liu, M.D.

    Tongji Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tianzhu Liu, M.D.

CONTACT

13098866448liutzh@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

May 9, 2024

First Posted

May 22, 2024

Study Start

June 12, 2024

Primary Completion (Estimated)

May 20, 2026

Study Completion (Estimated)

May 20, 2026

Last Updated

September 17, 2025

Record last verified: 2025-09

Locations

CN(1)