Incidence , Risk Factors and Outcomes of Haemodynamic Instability and Cardiac Arrest During Spine Surgery

• Conditions: Spine Surgery

• Registration Number: NCT05131854
• Lead Sponsor: Zagazig University

Brief Summary

Risk factors for cardiac arrest during spine surgery have been well defined, including lumbar fusion, age over 65 years, obesity, cardiovascular disease, ethnicity and ASA status. Bradycardia and asystole have been described under general anaesthesia in combined surgical cohorts: Proposed mechanisms include unopposed parasympathetic activation, enhanced vasovagal response to decreased venous return, and psychiatric stressors. The investigators prospectively will review patients candidates for spine surgery to explore potential incidence, contributory factors and outcomes to unexpected transient intraoperative haemodynamic instability, arrhythmia, and cardiac arrest during spine surgery as these data are needed to aid risk stratification and improve decision making for spine care teams.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-15
• Study First Submitted QC: 2021-11-11
• Study First Posted: 2021-11-23
• Study Start: 2021-11-25
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-22
• Last Update Posted: 2022-03-10
• Primary Completion: 2022-10-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Aged more than 18
2. Gender: both.
3. ASA grade I-II (American society of anesthiologists).
4. Prepared to spine surgery under general anesthesia

Exclusion Criteria

1. Ischemic heart patients
2. Hypertensive patients
3. Patients with atrial fibrillation or any previous history of attack of arrhythmias
4. Patients on B.B ( beta-blockers)
5. Chronic use of neuropsychiatric medications
6. Renal Impairment
7. Liver Dysfunction.
8. Any complications during the procedure as massive hemorrhage
9. Surgery for traumatic spinal cord

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of cardiac arrest during Spine Surgery	allover one year	To calculate Incidence of cardiac arrest during Spine Surgery
Incidence of Haemodynamic Instability during Spine Surgery	allover one year	To calculate Incidence of Haemodynamic Instability during Spine Surgery
outcomes of Haemodynamic Instability during Spine Surgery	allover one year	To calculate the rate of mortality of Haemodynamic Instability during Spine Surgery
Risk factors of cardiac arrest during Spine Surgery	allover one year	To analyze risk factors of cardiac arrest during Spine Surgery
outcomes of Cardiac Arrest during Spine Surgery	allover one year	To calculate the rate of mortality of cardiac arrest during Spine Surgery
Risk factors of Haemodynamic Instability during Spine Surgery	allover one year	To analyze risk factors of Haemodynamic Instability during Spine Surgery

Trial Locations

Locations (1)

Zagazig university; 🇪🇬 Zagazig, Egypt