Factors Influencing Hemodynamic Stability and Its Management in Patients Undergoing Pelvic Surgery Under Spinal and GA

NCT ID: NCT06767397

Last Updated: 2025-01-09

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

ACTIVE_NOT_RECRUITING

Total Enrollment

172 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-02-28

Study Completion Date

2025-03-01

Brief Summary

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Patients are at risk for hemodynamic instability both during and after surgery, as it is an independent predictor of long-term patient morbidity and length of hospital stay. The development of hemodynamic instability is caused by a number of factors. When these risk factors are prevented or treated, patients may experience less hemodynamic instability during pelvic surgery, as well as the morbidity and mortality that come with it in both spinal and general anesthesia.

Detailed Description

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The objective of this study was to evaluate the factors that affect the hemodynamic stability and evaluate the effectiveness of different management strategies employed to maintain hemodynamic stability during spinal and general anesthesia.

Conditions

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Pelvic Floor Disorders

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Interventions

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general anesthesia

To evaluate the factors that affect the hemodynamic stability in patients undergoing spinal anesthesia and general anesthesia during pelvic surgery.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Adult patients aged 18 years and older.
* ASA (American Society of Anesthesiologists) physical status classification I and II.
* Patients scheduled for elective pelvic surgery.
* Can give informed consent or has a legal representative to give consent.
* There are no contraindications to spinal or general anesthesia based on preoperative assessment (e.g, severe cardiovascular disease, no previous history of adverse anesthetic reactions).

Exclusion Criteria

* Age below 18 years.
* Emergency procedures or that require immediate intervention.
* Pregnancy or breastfeeding status.
* Conditions such as spinal cord disease and severe coagulopathy that are recognized contraindications to spinal or general anesthesia.
* ASA physical status classification III and above.
* History of severe adverse reactions to anesthesia or known allergy to anesthetic agents.
* Concurrent involvement in additional clinical trials that could have an impact on the treatment of anesthesia or hemodynamic results.
* Individuals with substantial comorbidities (such as uncontrolled hypertension or heart failure) that might complicate hemodynamic responses.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Superior University

OTHER

Sponsor Role lead

Responsible Party

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Muhammad Naveed Babur

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Mardan Medical Complex

Mardan, Khyber Pakhtunkhwa, Pakistan

Site Status

Countries

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Pakistan

Other Identifiers

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MSAHS/Batch-Spring23/035

Identifier Type: -

Identifier Source: org_study_id

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