Hypotension During SurgeryNCT06679933
Relationship Between Grip Strength and Intraoperative Hemodynamic Parameters
An observational study of Hypotension During Surgery and Geriatric Patient, run by Kirsehir Ahi Evran Universitesi at 1 site in Turkey (Türkiye).
Trial summary
In geriatric anesthesia, hand grip strength is used as an important biomarker to evaluate the general health status of elderly patients. Hand grip strength is considered an indicator of various factors, such as muscle function, physical endurance, nutritional status, and frailty, and can be helpful in geriatric… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hypotension During Surgery, Geriatric Patient, Hand Grip Strength
- What is being tested?
- Hand grip strength measurament
- How many people
- 105 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2022to 1 Mar 2023
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Male and female patients over the age of 65 with an ASA score of 1-3 who underwent elective surgery in our hospital (Kırşehir Research and Education Hospital) were included in the study. Patients were selected and included in the study during preoperative evaluation at the anesthesia clinic.
Who may be able to join
- Patients who are 65 years and older
- Patients undergoing elective surgery
- Patients suitable for spinal anesthesia
Who cannot join
- Presence of anatomical or neurological dysfunction of the upper extremity
- Failed spinal anesthesia
- Failure to measure hand grip strength accurately
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kırşehir Ahi Evran University Research and Education Hospital
Kırşehir, Kırşehir, 40100
About this study
Official title: Relationship Between Grip Strength and Intraoperative Hemodynamic Parameters in Geriatric Patients Undergoing Spinal Anesthesia
In geriatric anesthesia, hand grip strength is used as an important biomarker to evaluate the general health status of elderly patients. Hand grip strength is considered an indicator of various factors, such as muscle function, physical endurance, nutritional status, and frailty, and can be helpful in geriatric anesthesia practice to predict patients' response to anesthesia and determine their risk.
Hand grip strength is used as an important parameter in the pre-anesthesia evaluation of elderly patients. Low grip strength has been associated with postoperative complications (e.g., infection, pulmonary complications, prolonged hospitalization) and worse outcomes.Weak hand grip strength is related to the patient's degree of frailty. Frail patients may be less resistant to stress and respond more negatively to anesthesia.
One of the most important of these responses is intraoperative hypotension, and it is especially common in elderly patients. Since hypotension has possible adverse effects in the postoperative period, it is necessary to evaluate elderly patients in more detail during the preoperative evaluation in order to predict this and take the necessary precautions. Hand grip strength has been found to be associated with cardiovascular system health. With this study, the investigators wanted to evaluate whether measuring hand grip strength during preoperative evaluation would help evaluate the risk of intraoperative hypotension.
Read the detailed description
One of the most common intraoperative complications following spinal anesthesia is hypotension, which can occur in 16-33% of patients. In non-cardiac surgeries, there is a significant increase in postoperative major cardiac and cerebrovascular events within 30 days, parallel to the decrease in intraoperative mean arterial pressure within hypotensive limits. While there are different threshold values related to mean arterial pressure that can lead to organ damage in the literature, high-quality studies have found this value to be approximately 65 mmHg. However, in elderly patient groups, hypertension is frequently seen due to age-related arterial degeneration, which raises the perfusion thresholds of vital organs. In this context, rather than using a fixed threshold value, the variation of mean arterial pressure may provide a healthier perspective.
The risk of hypotension increases with physiological changes in the elderly, and the more widespread use of spinal anesthesia compared to general anesthesia in older adults underscores the need for better identification of risk factors.
Hand grip strength is a frequently used muscle strength measurement method in sports medicine and geriatric patient groups. It is usually measured in kg or lb with the help of a dynamometer. It provides valuable information in both rehabilitation studies and sarcopenia evaluation. Sarcopenia, or muscle wasting, is associated with frailty in geriatric patients and is one of the important indicators of cardiovascular health. For this reason, the deterioration of cardiovascular health with aging and the increase in the risk of hypotension, one of the side effects of anesthesia, can be predicted by muscle strength evaluation. The aim of our study is to examine whether muscle strength assessment is associated with intraoperative hypotension.
- Being tested
- Hand grip strength measurament
- Keywords
- Geriatric Anesthesia, Hang Grip Strength, Intraoperative Hypotension, Spinal Anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hand grip strength measuramentOther
That intervention includes making the patient sit down and rest for 5 minutes on a comfortable chair. Then make them handle a hand dynamometer with their dominant hand and ask them to squeeze it with all of their effort. Repeat that squeeze three times with 2-minute intervals. The highest number recorded on the dynamometer is the hand grip strength of the patient.
What is being measured
The primary outcome is the main question the study is designed to answer.
Is low grip strength related with more hypotension?
We examined whether low hand grip strength was associated with the frequency of intraoperative hypotension.
Measured: During the surgery
Secondary outcomes (1)
Is there any difference in blood pressure changes between patients with low hand grip strength and patients with high hand grip strength.
Male and female participants were evaluated in two separate groups, and a threshold value was determined for hand grip strength in accordance with the literature. The temporal change in blood pressures of patients below and above this threshold value was examined and whether there was a difference.
Measured: During the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2024
- Study start1 Jan 2022
- Primary completion1 Jan 2023
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hypotension During SurgeryStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 105 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Kirsehir Ahi Evran Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Nur Arslan, Kirsehir Ahi Evran Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06679933
- Sponsor's protocol ID
- 2021-19/192
- Status last verified
- Nov 2024
- First submitted
- 4 Nov 2024
- Last updated
- 8 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available.
Publications
Gregory A, Stapelfeldt WH, Khanna AK, Smischney NJ, Boero IJ, Chen Q, Stevens M, Shaw AD. Intraoperative Hypotension Is Associated With Adverse Clinical Outcomes After Noncardiac Surgery. Anesth Analg. 2021 Jun 1;132(6):1654-1665. doi: 10.1213/ANE.0000000000005250.
PubMed 33177322Carpenter RL, Caplan RA, Brown DL, Stephenson C, Wu R. Incidence and risk factors for side effects of spinal anesthesia. Anesthesiology. 1992 Jun;76(6):906-16. doi: 10.1097/00000542-199206000-00006.
PubMed 1599111
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Grip Strength and Intraoperative Hemodynamic Parameters in Geriatric Patients Undergoing Spinal Anesthesia
- ClinicalTrials.gov ID
- NCT06679933
- Acronym / sponsor ID
- 2021-19/192
- Keywords
- Geriatric Anesthesia, Hang Grip Strength, Intraoperative Hypotension, Spinal Anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Kirsehir Ahi Evran UniversitesiUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 8 Nov 2024 (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.
In geriatric anesthesia, hand grip strength is used as an important biomarker to evaluate the general health status of elderly patients. Hand grip strength is considered an indicator of various factors, such as muscle function, physical endurance, nutritional status, and frailty, and can be helpful in geriatric anesthesia practice to predict patients' response to anesthesia and determine their risk.
Hand grip strength is used as an important parameter in the pre-anesthesia evaluation of elderly patients. Low grip strength has been associated with postoperative complications (e.g., infection, pulmonary complications, prolonged hospitalization) and worse outcomes.Weak hand grip strength is related to the patient's degree of frailty. Frail patients may be less resistant to stress and respond more negatively to anesthesia.
One of the most important of these responses is intraoperative hypotension, and it is especially common in elderly patients. Since hypotension has possible adverse effects in the postoperative period, it is necessary to evaluate elderly patients in more detail during the preoperative evaluation in order to predict this and take the necessary precautions. Hand grip strength has been found to be associated with cardiovascular system health. With this study, the investigators wanted to evaluate whether measuring hand grip strength during preoperative evaluation would help evaluate the risk of intraoperative hypotension.
Detailed description
One of the most common intraoperative complications following spinal anesthesia is hypotension, which can occur in 16-33% of patients. In non-cardiac surgeries, there is a significant increase in postoperative major cardiac and cerebrovascular events within 30 days, parallel to the decrease in intraoperative mean arterial pressure within hypotensive limits. While there are different threshold values related to mean arterial pressure that can lead to organ damage in the literature, high-quality studies have found this value to be approximately 65 mmHg. However, in elderly patient groups, hypertension is frequently seen due to age-related arterial degeneration, which raises the perfusion thresholds of vital organs. In this context, rather than using a fixed threshold value, the variation of mean arterial pressure may provide a healthier perspective.
The risk of hypotension increases with physiological changes in the elderly, and the more widespread use of spinal anesthesia compared to general anesthesia in older adults underscores the need for better identification of risk factors.
Hand grip strength is a frequently used muscle strength measurement method in sports medicine and geriatric patient groups. It is usually measured in kg or lb with the help of a dynamometer. It provides valuable information in both rehabilitation studies and sarcopenia evaluation. Sarcopenia, or muscle wasting, is associated with frailty in geriatric patients and is one of the important indicators of cardiovascular health. For this reason, the deterioration of cardiovascular health with aging and the increase in the risk of hypotension, one of the side effects of anesthesia, can be predicted by muscle strength evaluation. The aim of our study is to examine whether muscle strength assessment is associated with intraoperative hypotension.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Male and female patients over the age of 65 with an ASA score of 1-3 who underwent elective surgery in our hospital (Kırşehir Research and Education Hospital) were included in the study. Patients were selected and included in the study during preoperative evaluation at the anesthesia clinic.
Key inclusion criteria (3 listed)
- Patients who are 65 years and older
- Patients undergoing elective surgery
- Patients suitable for spinal anesthesia
Key exclusion criteria (3 listed)
- Presence of anatomical or neurological dysfunction of the upper extremity
- Failed spinal anesthesia
- Failure to measure hand grip strength accurately
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 |
|---|---|---|
| Hand grip strength measuramentThat intervention includes making the patient sit down and rest for 5 minutes on a comfortable chair. Then make them handle a hand dynamometer with their dominant hand and ask them to squeeze it with all of their effort. Repeat that squeeze three times with 2-minute intervals. The highest number recorded on the dynamometer is the hand grip strength of the patient. | Other | – |
Primary outcome
Is low grip strength related with more hypotension?
Time frame: During the surgery
We examined whether low hand grip strength was associated with the frequency of intraoperative hypotension.
1 secondary outcome
Is there any difference in blood pressure changes between patients with low hand grip strength and patients with high hand grip strength.
Time frame: During the surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2024.
- Results publication: PubMed 33177322Gregory A, Stapelfeldt WH, Khanna AK, Smischney NJ, Boero IJ, Chen Q, Stevens M, Shaw AD. Intraoperative Hypotension Is Associated With Adverse Clinical Outcomes After Noncardiac Surgery. Anesth Analg. 2021 Jun 1;132(6):1654-1665. doi: 10.1213/ANE.0000000000005250.
- Results publication: PubMed 1599111Carpenter RL, Caplan RA, Brown DL, Stephenson C, Wu R. Incidence and risk factors for side effects of spinal anesthesia. Anesthesiology. 1992 Jun;76(6):906-16. doi: 10.1097/00000542-199206000-00006.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available.
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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 Hypotension During Surgery and Geriatric Patient, run by Kirsehir Ahi Evran Universitesi at 1 site in Turkey (Türkiye).
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 8 Nov 2024. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Is low grip strength related with more hypotension? (time frame: During the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06679933, which also lists 2 linked publications.
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 8 Nov 2024.