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Spinal Versus General Anesthesia on Postoperative Pulmonary Complications

T

Tongji Hospital

Status

Enrolling

Conditions

Hip Fractures
Pulmonary Complication
Anesthesia

Treatments

Procedure: general anesthesia
Procedure: spinal anesthesia

Study type

Interventional

Funder types

Other

Identifiers

NCT06425627
TongjiHospital102114

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 estimated patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

40 participants in 2 patient groups

spinal anesthesia
Experimental group
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.
Treatment:
Procedure: spinal anesthesia
general anesthesia
Experimental group
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.
Treatment:
Procedure: general anesthesia

Trial contacts and locations

1

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Central trial contact

Tianzhu Liu, M.D.

Data sourced from clinicaltrials.gov

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