An observational study in Total Fluid Volume Decreased, sponsored by Rajiv Gandhi Cancer Institute & Research Center, India. Completed at 1 site in India. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-01-18.
Sponsored by Rajiv Gandhi Cancer Institute & Research Center, India · Observational
Patients undergoing major Oncosurgeries are fluid deficit due to preoperative fasting , inadequate intake due to disease hence prone to development of hypotension after induction of general anaesthesia owing to vasodilatory effects of anesthetic induction agents. Investigators plan study to measure ultrasound guided Superior Vena Cava and Inferior Vena Cava collapsibility Index as predictors of hypotension after induction of General anaesthesia.
Investigators plan prospective study , written informed will be taken from all included patients. In the OR 5 lead ECG, NIBP,SPO2 monitors will be attached , patients will be explained about Ultrasound imaging . Preinduction using SONOSITE EDGE II ultrasonography machine and placing high frequency linear array probe (6-13 Hz) beneath the middle of the clavicle aligned in deltopectoral groove to obtain short axis view of Subclavian/Infraclavicular axillary vein in B-Mode (2-D imaging). Doppler pulse waveform and minimum and maximum diameter measurements of SVC will be obtained in M-mode , both during spontaneous breathing and after deep inspiration, using digital calipers after freezing the image. The collapsibility index CI will be calculated using the following equation SCV AV CI = (dSCV max- dSCV min)/ dSCV max ×100.
A phased array or cardiac ultrasound probe (1-5Hz) will be placed in the subxiphoid window to view IVC at the junction of IVC with right atrium .Then the transducer will be adjusted to obtain the long axis view of IVC. Doppler pulse waveform will be obtained to ensure imaging of IVC and then in the M mode the minimum and maximum diameter measurements of IVC will be obtained both during spontaneous breathing and after deep inspiration, using digital calipers after freezing the image. The collapsibility index CI will calculated using the following equation:IVC CI = (dIVCmax- dIVCmin )/ dIVCmax ×100 . In all the patients both SVC and IVC -CI will be calculated.
All patients will receive standard General Anesthesia with IV Fentanyl 1-2 mcg/kg , Sleeping dose propofol , Atracurium 0.5mg/kg and orally placed Endotracheal tube.The heart rate (HR) and mean arterial pressure (MAP) will be recorded in two phases .Intraoperative hypotension (IOH) been defined as MAP\<60mmHg or >30%decrease in MAP from baseline.
1,003 studies on the registry are indexed under Hypotension; 173 are open to participants now.
This study's enrollment of 120 is above the median of 84 across 294 observational studies indexed under Hypotension.
Browse Hypotension studies →Rajiv Gandhi Cancer Institute & Research Center, India is the lead sponsor of 25 studies on the registry; 3 are open to participants now.
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Adult patients undergoing major Onco-surgeries.
Exclusion Criteria:
Preoperative ultrasound guided Superior Vena Cava collapsibility Index will be measured with patient breathing spontaneously and on deep inspiration.
Other: Ultrasound guided Superior Vena Cava Collapsibility Index
Preoperative Ultrasound guided Inferior Vena Cava collapsibility Index will be measured with patient breathing spontaneously and on deep inspiration.
Other: Inferior Vena Cava Collapsibility Index
Preoperative Ultrasound guided Superior Vena Cava Collapsibility Index will be measured
Preoperative Inferior Vena Cava Collapsibility Index will be measured.
To compare Subclavian Vein Collapsibility Index in percentage with Inferior Vena Cava Collapsibility Index in percentage as predictor of hypotension after induction of General anaesthesia
Preoperative Ultrasound guided Subclavian / Infraclavicular Axillary Vein Collapsibility Index and Inferior Vena Cava Collapsibility Index was measured with spontaneous breathing and on deep inspiration.
Time frame: 30 minutes prior to induction of anaesthesia
To evaluate the sensitivity of SVC -CI and IVC -CI as a predictor of hypotension after induction of General anesthesia .
Preoperative US Guided SVC-CI in percentage and IVC -CI in percentage values will be obtained and statistical analysis will be done
Time frame: 30 minutes prior to induction of anaesthesia
Plan to share: No
This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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Rajiv Gandhi Cancer Institute & Research Center, India