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

NCT06767397 | Active Not Recruiting DMC

• 1 other identifier: MSAHS/Batch-Spring23/035
• Study Type: observational
• Target: 172
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pelvic Floor Disorders

Outcome Measures

Primary Outcomes (2)

• Hemodynamic instability

  Hemodynamic instability determined by criteria such as fluctuations of ± 20% in the systolic or diastolic blood pressure from the baseline and measured in millimetre of mercury), fluctuations in heart rate (e.g., pulse rate ± 10% of baseline), and the lack of clinically significant hypotension or episodes of bradycardia.Oxygen saturation measured by pulse oximeter and \< 90% of SPO2 was considered desaturated.

  12 Months

• Self-designed questionnaire

  Self-designed questionnaire for the evaluation of the factors like Age in years, weight in kilograms, Physical health status by (ASA) American Society of Anesthesiologists classification where ASA I was physically fit patients having only surgical pathology and ASA II patient with mild systemic disease. scoring from (1-100)

  12 Months

Interventions

general anesthesia DIAGNOSTIC_TEST

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

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Intraoperatively hemodunamic instability during spinal and general anesthesia was adressed and also evaluate its management.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Superior University: lead

Study Sites (1)

Mardan Medical Complex

Mardan, Khyber Pakhtunkhwa, Pakistan

Location

MeSH Terms

Conditions

Pelvic Floor Disorders

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pregnancy Complications; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 18, 2024
• First Posted: January 9, 2025
• Study Start: February 28, 2024
• Primary Completion: August 1, 2024
• Study Completion: March 1, 2025
• Last Updated: January 9, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)