Pelvic Floor DisordersNCT06767397
Factors Influencing Hemodynamic Stability and Its Management in Patients Undergoing Pelvic Surgery Under Spinal and GA
An observational study of Pelvic Floor Disorders, run by Superior University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Pelvic Floor Disorders
- What is being tested?
- general anesthesia
- How many people
- 172 participants
- Where
- 1 sitePakistan
- Study dates
- 28 Feb 2024to 1 Mar 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Intraoperatively hemodunamic instability during spinal and general anesthesia was adressed and also evaluate its management.
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Factors Influencing the Hemodynamic Stability and Its Management in Patients Undergoing Pelvic Surgery Under Spinal and General Anesthesia
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.
Read the detailed description
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
- Pelvic Floor Disorders
- Being tested
- general anesthesia
- Medical subject headings
- Pelvic Floor Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
general anesthesiaDiagnostic test
To evaluate the factors that affect the hemodynamic stability in patients undergoing spinal anesthesia and general anesthesia during pelvic surgery.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2025
- Study start28 Feb 2024
- Primary completion1 Aug 2024
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Floor DisordersStudies of the same condition, open and under way.
- More trials run by Superior UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- Superior University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Naveed Babur, Superior University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06767397
- Sponsor's protocol ID
- MSAHS/Batch-Spring23/035
- Status last verified
- Jan 2025
- First submitted
- 18 Dec 2024
- Last updated
- 9 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Influencing the Hemodynamic Stability and Its Management in Patients Undergoing Pelvic Surgery Under Spinal and General Anesthesia
- ClinicalTrials.gov ID
- NCT06767397
- Acronym / sponsor ID
- MSAHS/Batch-Spring23/035
- Conditions
- Pelvic Floor Disorders
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 172 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 28 Feb 2024 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 9 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Intraoperatively hemodunamic instability during spinal and general anesthesia was adressed and also evaluate its management.
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| general anesthesiaTo evaluate the factors that affect the hemodynamic stability in patients undergoing spinal anesthesia and general anesthesia during pelvic surgery. | Diagnostic test | – |
Primary outcome
Hemodynamic instability
Time frame: 12 Months
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.
Self-designed questionnaire
Time frame: 12 Months
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Floor Disorders, run by Superior University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 9 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemodynamic instability (time frame: 12 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2025.