Hypotension on InductionNCT04682717
Perfusion Index as a Predictor of Postinduction Hypotension of General Anesthesia in Geriatric Patients
An observational study of Hypotension on Induction, run by Cairo University at 1 site in Egypt.
Trial summary
The influence of hemodynamic aberrations during anesthesia on adverse outcomes is an important clinical issue. There is evidence that hypotension and hypertension during general anesthesia are independently associated with adverse outcomes in patients having both noncardiac and cardiac surgery.One of the intervals of… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypotension on Induction
- What is being tested?
- perfusion index monitoring for postinduction hypotension
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2020to 3 Mar 2021
- 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
- Healthy volunteers accepted
- Older adult
Study population: Thirty patients aged > 65 years undergoing elective surgery under general anesthesia performed in general surgery theater at Kasr Al-Ainy hospital.
Who may be able to join
- aged > 65 years
- belonging to the American Society of Anesthesiologists' Physical Status I to II
- elective surgery under general anesthesia
Who cannot join
- hypertension,
- vasoactive medications,
- difficult airway
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Perfusion Index as a Predictor of Hypotension Following Propofol Induction of General Anesthesia in Geriatric Patients - A Prospective Observational Study.
The influence of hemodynamic aberrations during anesthesia on adverse outcomes is an important clinical issue. There is evidence that hypotension and hypertension during general anesthesia are independently associated with adverse outcomes in patients having both noncardiac and cardiac surgery.One of the intervals of general anesthesia during which hypotension is prevalent is the period after the induction of anesthesia but before the onset of surgical stimulation. This period is particularly prone to decreased vigilance with regard to hemodynamic changes.
Statistically significant predictors of hypotension 0-10 min after anesthetic induction included: ASA III-V, baseline MAP <70 mm Hg, age > or =50 years, the use of propofol for induction of anesthesia, and increasing induction dosage of fentanyl.While the potential preoperative factors associated with hypotension 5-10 min after the induction of anesthesia in patients with ASA I-II included baseline MAP 70 mm Hg, age > 50 years, use of propofol during induction, and magnitude of fentanyl dose during induction.
Read more
Perfusion index (PI) is a relatively new parameter estimating the pulsatility of blood in the extremities, calculated using infrared spectrum as part of plethysmography waveform processing. It is a simple,cost-effective and non-invasive method of assessing peripheral perfusion determined by the percentage of pulsatile to non-pulsatile blood flow in the extremities. PI indicates the status of the microcirculation which is densely innervated by sympathetic nerves, and therefore, is affected by multiple factors responsible for vasoconstriction or vasodilatation of the microvasculature.It is an indicator of systemic vascular resistance (SVR).
PI is said to be useful in monitoring depth of anesthesia, hypothermia, successful epidural placement in parturients, adequate relief from ureteric obstruction, response to fluid therapy in critically ill and intraoperative patients and adequacy of circulation in newborn.The value of PI is inversely related to the vascular tone, though not in a linear fashion. Therefore, vasodilatation reflecting higher baseline PI has been associated with reductions in blood pressure (BP) following spinal anesthesia.The resting SVR can influence incidence and severity of post-spinal hypotension in parturients.
It has been established that a positive correlation between pre-anesthetic plethysmographic variability index (PVI) and reduction in BP following induction of anesthesia using propofol in healthy adults, that is, higher PVI was associated with more mean arterial pressure (MAP) reductions. Similarly, a significant proportion of hypotension after induction of anesthesia with propofol can be attributed to the baseline SVR.
Mehandale SG. and Rajasekhar P. underwent A prospective observational study on fifty adults for the use of Perfusion index as a predictor of hypotension following propofol induction and revealed that a baseline PI <1.05 predicted incidence of hypotension at 5 min with sensitivity 93%, specificity 71%, positive predictive value (PPV) 68% and negative predictive value (NPV) 98%.
the hypothesised was that it is possible to define a threshold baseline value of PI that predicts hypotension based on individual's pre-induction SVR in patients > 65 years old following anesthetic induction with propofol and fentanyl as multifactorial risk for postinduction hypotension.
Outcomes:
A cut-off value of baseline PI below which hypotension at 5 min post induction could be predicted will be the primary outcome, while positive and negative predictive values at 15 minutes will be secondary outcomes.
- Conditions
- Hypotension on Induction
- Being tested
- perfusion index monitoring for postinduction hypotension
- Keywords
- geriatris, postinduction hypotension, perfusion index
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
perfusion index monitoring for postinduction hypotensionDevice
Hemodynamic parameters will be recorded at 1-min intervals till 10 min after intubation. Hypotension will be defined as a drop in SBP to <30% of baseline or absolute MAP <60 mmHg. MAP <55 mmHg (severe hypotension) will be treated immediately by rapid intravenous fluid administration (10 ml/kg) and ephedrine sulphate 6 mg IV boluses. Bradycardia will be defined as HR <50 bpm or decrease by more than 30% below baseline value, whichever will be lower and will be treated with atropine 0.6 mg IV boluses. The incidence of hypotension will be calculated in 2 sets - 5 min after induction of anesthesia (effect of induction agent) and first 15 min after induction (effect of induction process and endotracheal intubation).
| Study group | Role | What they receive |
|---|---|---|
| PI group | A cut-off value of baseline PI below which hypotension at 5 min post induction could be predicted will be the primary outcome, while positive and negative predictive values at 15 minutes will be secondary outcomes. Receives: Device: perfusion index monitoring for postinduction hypotension |
What is being measured
The primary outcome is the main question the study is designed to answer.
perfusion index
A cut-off value of baseline PI below which hypotension post induction could be predicted
Measured: 5 minutes postinduction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2020
- Study start1 Dec 2020
- Primary completion28 Feb 2021
- Study completion3 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Hypotension on InductionStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sherif Abdullah Mohamed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04682717
- Sponsor's protocol ID
- N-12/2020
- Status last verified
- May 2021
- First submitted
- 19 Dec 2020
- Last updated
- 4 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: not to share
Publications
Jain U, Laflamme CJ, Aggarwal A, Ramsay JG, Comunale ME, Ghoshal S, Ngo L, Ziola K, Hollenberg M, Mangano DT. Electrocardiographic and hemodynamic changes and their association with myocardial infarction during coronary artery bypass surgery. A multicenter study. Multicenter Study of Perioperative Ischemia (McSPI) Research Group. Anesthesiology. 1997 Mar;86(3):576-91. doi: 10.1097/00000542-199703000-00009.
PubMed 9066323Loeb RG. A measure of intraoperative attention to monitor displays. Anesth Analg. 1993 Feb;76(2):337-41.
PubMed 8424512Reich DL, Hossain S, Krol M, Baez B, Patel P, Bernstein A, Bodian CA. Predictors of hypotension after induction of general anesthesia. Anesth Analg. 2005 Sep;101(3):622-628. doi: 10.1213/01.ANE.0000175214.38450.91.
PubMed 16115962van Genderen ME, Bartels SA, Lima A, Bezemer R, Ince C, Bakker J, van Bommel J. Peripheral perfusion index as an early predictor for central hypovolemia in awake healthy volunteers. Anesth Analg. 2013 Feb;116(2):351-6. doi: 10.1213/ANE.0b013e318274e151. Epub 2013 Jan 9.
PubMed 23302972
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perfusion Index as a Predictor of Hypotension Following Propofol Induction of General Anesthesia in Geriatric Patients - A Prospective Observational Study.
- ClinicalTrials.gov ID
- NCT04682717
- Acronym / sponsor ID
- N-12/2020
- Conditions
- Hypotension on Induction
- Keywords
- geriatris, postinduction hypotension, perfusion index
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 3 Mar 2021 (actual)
- First posted
- 24 Dec 2020 (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.
The influence of hemodynamic aberrations during anesthesia on adverse outcomes is an important clinical issue. There is evidence that hypotension and hypertension during general anesthesia are independently associated with adverse outcomes in patients having both noncardiac and cardiac surgery.One of the intervals of general anesthesia during which hypotension is prevalent is the period after the induction of anesthesia but before the onset of surgical stimulation. This period is particularly prone to decreased vigilance with regard to hemodynamic changes.
Statistically significant predictors of hypotension 0-10 min after anesthetic induction included: ASA III-V, baseline MAP <70 mm Hg, age > or =50 years, the use of propofol for induction of anesthesia, and increasing induction dosage of fentanyl.While the potential preoperative factors associated with hypotension 5-10 min after the induction of anesthesia in patients with ASA I-II included baseline MAP 70 mm Hg, age > 50 years, use of propofol during induction, and magnitude of fentanyl dose during induction.
Perfusion index (PI) is a relatively new parameter estimating the pulsatility of blood in the extremities, calculated using infrared spectrum as part of plethysmography waveform processing. It is a simple,cost-effective and non-invasive method of assessing peripheral perfusion determined by the percentage of pulsatile to non-pulsatile blood flow in the extremities. PI indicates the status of the microcirculation which is densely innervated by sympathetic nerves, and therefore, is affected by multiple factors responsible for vasoconstriction or vasodilatation of the microvasculature.It is an indicator of systemic vascular resistance (SVR).
PI is said to be useful in monitoring depth of anesthesia, hypothermia, successful epidural placement in parturients, adequate relief from ureteric obstruction, response to fluid therapy in critically ill and intraoperative patients and adequacy of circulation in newborn.The value of PI is inversely related to the vascular tone, though not in a linear fashion. Therefore, vasodilatation reflecting higher baseline PI has been associated with reductions in blood pressure (BP) following spinal anesthesia.The resting SVR can influence incidence and severity of post-spinal hypotension in parturients.
It has been established that a positive correlation between pre-anesthetic plethysmographic variability index (PVI) and reduction in BP following induction of anesthesia using propofol in healthy adults, that is, higher PVI was associated with more mean arterial pressure (MAP) reductions. Similarly, a significant proportion of hypotension after induction of anesthesia with propofol can be attributed to the baseline SVR.
Mehandale SG. and Rajasekhar P. underwent A prospective observational study on fifty adults for the use of Perfusion index as a predictor of hypotension following propofol induction and revealed that a baseline PI <1.05 predicted incidence of hypotension at 5 min with sensitivity 93%, specificity 71%, positive predictive value (PPV) 68% and negative predictive value (NPV) 98%.
the hypothesised was that it is possible to define a threshold baseline value of PI that predicts hypotension based on individual's pre-induction SVR in patients > 65 years old following anesthetic induction with propofol and fentanyl as multifactorial risk for postinduction hypotension.
Outcomes:
A cut-off value of baseline PI below which hypotension at 5 min post induction could be predicted will be the primary outcome, while positive and negative predictive values at 15 minutes will be secondary outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PI group | – | Device: perfusion index monitoring for postinduction hypotensionA cut-off value of baseline PI below which hypotension at 5 min post induction could be predicted will be the primary outcome, while positive and negative predictive values at 15 minutes will be secondary outcomes. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Thirty patients aged > 65 years undergoing elective surgery under general anesthesia performed in general surgery theater at Kasr Al-Ainy hospital.
Key inclusion criteria (3 listed)
- aged > 65 years
- belonging to the American Society of Anesthesiologists' Physical Status I to II
- elective surgery under general anesthesia
Key exclusion criteria (3 listed)
- hypertension,
- vasoactive medications,
- difficult airway
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 |
|---|---|---|
| perfusion index monitoring for postinduction hypotensionHemodynamic parameters will be recorded at 1-min intervals till 10 min after intubation. Hypotension will be defined as a drop in SBP to <30% of baseline or absolute MAP <60 mmHg. MAP <55 mmHg (severe hypotension) will be treated immediately by rapid intravenous fluid administration (10 ml/kg) and ephedrine sulphate 6 mg IV boluses. Bradycardia will be defined as HR <50 bpm or decrease by more than 30% below baseline value, whichever will be lower and will be treated with atropine 0.6 mg IV boluses. The incidence of hypotension will be calculated in 2 sets - 5 min after induction of anesthesia (effect of induction agent) and first 15 min after induction (effect of induction process and endotracheal intubation). | Device | PI group |
Primary outcome
perfusion index
Time frame: 5 minutes postinduction
A cut-off value of baseline PI below which hypotension post induction could be predicted
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 4 May 2021.
- Background: PubMed 9066323Jain U, Laflamme CJ, Aggarwal A, Ramsay JG, Comunale ME, Ghoshal S, Ngo L, Ziola K, Hollenberg M, Mangano DT. Electrocardiographic and hemodynamic changes and their association with myocardial infarction during coronary artery bypass surgery. A multicenter study. Multicenter Study of Perioperative Ischemia (McSPI) Research Group. Anesthesiology. 1997 Mar;86(3):576-91. doi: 10.1097/00000542-199703000-00009.
- Background: PubMed 8424512Loeb RG. A measure of intraoperative attention to monitor displays. Anesth Analg. 1993 Feb;76(2):337-41.
- Background: PubMed 16115962Reich DL, Hossain S, Krol M, Baez B, Patel P, Bernstein A, Bodian CA. Predictors of hypotension after induction of general anesthesia. Anesth Analg. 2005 Sep;101(3):622-628. doi: 10.1213/01.ANE.0000175214.38450.91.
- Background: PubMed 23302972van Genderen ME, Bartels SA, Lima A, Bezemer R, Ince C, Bakker J, van Bommel J. Peripheral perfusion index as an early predictor for central hypovolemia in awake healthy volunteers. Anesth Analg. 2013 Feb;116(2):351-6. doi: 10.1213/ANE.0b013e318274e151. Epub 2013 Jan 9.
- Individual participant dataSharing planned: No. not to share
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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 on Induction, run by Cairo University at 1 site in Egypt.
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 4 May 2021. 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 Egypt. 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?
perfusion index (time frame: 5 minutes postinduction). 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 NCT04682717, which also lists 4 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 4 May 2021.