IVC Ultrasonography Versus Plethysmographic Variability Index for Prediction of General Anesthesia Induction Hypotension

• Conditions: Hypotension on Induction
• Interventions: Device: IVC Ultrasonography; Device: Plethysmographic variability index (PVI) and perfusion index readings (PI)

• Registration Number: NCT04238234
• Lead Sponsor: Cairo University

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.

Study Timeline

• Study First Submitted: 2020-01-20
• Study First Submitted QC: 2020-01-20
• Study First Posted: 2020-01-23
• Study Start: 2021-08-05
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-04
• Last Update Posted: 2021-10-06
• Primary Completion: 2021-10-30
• Study Completion: 2021-11-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
study group	Plethysmographic variability index (PVI) and perfusion index readings (PI)	Participants will be adult patients (above 18 years), ASA I-II-III, scheduled for elective surgeries under general anesthesia.
study group	IVC Ultrasonography	Participants will be adult patients (above 18 years), ASA I-II-III, scheduled for elective surgeries under general anesthesia.

Primary Outcome Measures

Name	Time	Method
Comparison of the accuracy (Area under receiver operating characteristic curves) of PVI and IVC variation in prediction of post-induction hypotension	10 minutes before general anesthesia	Maximum and minimum IVC diameters over a single respiratory cycle will be measured using a built-in software.; The CI will be calculated as: CI = (dIVCmax - dIVCmin)/dIVCmax CI will be expressed as a percentage

Secondary Outcome Measures

Name	Time	Method
Heart rate	20 minutes	measured at 1-minute intervals starting from the baseline preoperative reading until skin incision as follows: preinduction reading - 1-minute postinduction reading - 2-minute postinduction reading - preintubation reading - one-minute postintubation reading until skin incision
Mean arterial blood pressure	20 minutes	measured at 1-minute intervals starting from the baseline preoperative reading until skin incision as follows: preinduction reading - 1-minute postinduction reading - 2-minute postinduction reading - preintubation reading - one-minute postintubation reading until skin incision
Maximum and minimum IVC diameters	10 minutes	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 (PVI) and a perfusion index readings (PI)	3 minutes	Three readings, on one-minute interval before general anesthesia induction

Trial Locations

Locations (2)

Kasr alainy; 🇪🇬 Cairo, Egypt

Almaza Militrary Hospital; 🇪🇬 Cairo, Egypt