Clinical trial NCT04238234: IVC Ultrasonography Versus Plethysmographic Variability Index for Prediction of General Anesthesia Induction Hypotension
Official title: Comparison of Ultrasound-based Measures of Inferior Vena Cava and Plethysmographic Variability Index for Prediction of Hypotension During Induction of General Anesthesia; Prospective Cohort Study.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypotension on Induction
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-01-23
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants will be adult patients (above 18 years), ASA I-II-III, scheduled for elective surgeries under general anaesthesia.

Brief summary: This thesis aims to evaluate the ability of preoperative plethysmographic variability index to predict post-induction hypotension in comparison with ultrasound measurements of inferior vena cava (IVC) diameter.

Detailed description: Prospective cohort study. Upon arrival to the operating room, routine monitors (ECG, pulse oximetry, and non-invasive blood pressure monitor) will be applied, intravenous line will be secured and routine premedications (ranitidine 50 mg and ondansteron 4mg) will be administrated.

Then inferior vena cava ultrasonography will be performed. Maximum and minimum IVC diameters over a single respiratory cycle will be measured using built-in software. The CI will be calculated as: CI = (dIVCmax - dIVCmin)/dIVCmax , it will be expressed as a percentage.

Plethysmographic variability index and a perfusion index readings will be taken preinduction in the form of three readings on one-minute interval.

Induction of anaesthesia will be achieved using propofol (2 mg/Kg) and atracurium (0.5 mg/Kg). Endotracheal tube will be inserted after 3 minutes of mask ventilation.

Anaesthesia will be maintained by isoflurane (1-1.5%) and atracurium 10 mg increments every 20 minutes. Ringer lactate solution will be infused at a rate of 2 mL/Kg/hour.

Any episode of hypotension (defined as mean arterial pressure \< 80% of the baseline reading) will be managed by 5mcg norepinephrine.

Eligibility criteria: Inclusion Criteria:

* Adult patients (\>18years)
* ASA I-II-III
* Patients scheduled for elective surgeries under general anaesthesia.

Exclusion Criteria:

* Operations which will last for less than 15 minutes.
* Patients with cardiac morbidities (impaired contractility with ejection fraction \< 40% and tight valvular lesions, unstable angina).
* Patients with heart block and arrhythmia (atrial fibrillation and frequent ventricular or supraventricular premature beat).
* Patient with decompansted respiratory disease (poor functional capacity, generalized wheezes, peripheral O2 saturation \< 90% on room air).
* Patients with increased intraabdominal pressure (intrabdominal mass compressing IVC).
* Patients with peripheral vascular disease or long standing DM affecting PVI readings.
* Pregnancy

Primary outcomes:
measure: Comparison of the accuracy (Area under receiver operating characteristic curves) of PVI and IVC variation in prediction of post-induction hypotension
timeFrame: 10 minutes before general anesthesia
Secondary outcomes:
measure: Plethysmographic variability index (PVI) and a perfusion index readings (PI)
timeFrame: 3 minutes
measure: Maximum and minimum IVC diameters
timeFrame: 10 minutes
measure: Mean arterial blood pressure
timeFrame: 20 minutes
measure: Heart rate
timeFrame: 20 minutes
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr alainy
city: Cairo
country: Egypt
facility: Almaza Militrary Hospital
Study officials:
affiliation: Cairo University
name: Bassant abdelhamid, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wesselink EM, Kappen TH, Torn HM, Slooter AJC, van Klei WA. Intraoperative hypotension and the risk of postoperative adverse outcomes: a systematic review. Br J Anaesth. 2018 Oct;121(4):706-721. doi: 10.1016/j.bja.2018.04.036. Epub 2018 Jun 20.
citation: Zhang J, Critchley LA. Inferior Vena Cava Ultrasonography before General Anesthesia Can Predict Hypotension after Induction. Anesthesiology. 2016 Mar;124(3):580-9. doi: 10.1097/ALN.0000000000001002.
citation: Tsuchiya M, Yamada T, Asada A. Pleth variability index predicts hypotension during anesthesia induction. Acta Anaesthesiol Scand. 2010 May;54(5):596-602. doi: 10.1111/j.1399-6576.2010.02225.x. Epub 2010 Mar 10.