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

NCT ID: NCT05131854

Last Updated: 2022-03-10

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

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-25

Study Completion Date

2022-12-31

Brief Summary

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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

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Conditions

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Spine Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zagazig University

OTHER_GOV

Sponsor Role lead

Responsible Party

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Essamedin Mamdouh Negm

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Zagazig university

Zagazig, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Essamedin Negm, MD

Role: CONTACT

0021098123058

Essam youssef

Role: CONTACT

0021002815325

Facility Contacts

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zagazig university

Role: primary

Other Identifiers

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8078-13-10-2021

Identifier Type: -

Identifier Source: org_study_id

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