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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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.

Egypt1 site
  • Cairo University hospitals

    Cairo, Manial, 12511

Other trials in Egypt

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.

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 groups in NCT04682717
Study groupRoleWhat they receive
PI groupA 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.

  1. 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.

  1. First posted24 Dec 2020
  2. Study start1 Dec 2020
  3. Primary completion28 Feb 2021
  4. Study completion3 Mar 2021

Resources

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)
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 9066323
  • Loeb RG. A measure of intraoperative attention to monitor displays. Anesth Analg. 1993 Feb;76(2):337-41.

    PubMed 8424512
  • Reich 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 16115962
  • van 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

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.

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