Preoperative Ultrasound Guided Evaluation of SVC-CI and IVC -CI as Predictors of Hypotension After Induction of Anaesthesia in Major Onco-surgery

Completed

• Conditions: Total Fluid Volume Decreased
• Interventions: Other: Ultrasound guided Superior Vena Cava Collapsibility Index; Other: Inferior Vena Cava Collapsibility Index

• Registration Number: NCT05548920
• Lead Sponsor: Rajiv Gandhi Cancer Institute & Research Center, India

Brief Summary

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.

Detailed Description

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. Post induction phase: Readings will be taken at 1 min intervals from the start of induction till intubation (upto 5 minutes) and

2. Post intubation phase: Readings will be taken at 2 min intervals upto 10 min and at 5 min intervals up to 30 mins or till incision . Each hypotensive episode encountered will be treated with leg lifting first (lifting both lower extremities for 2 minutes by technical staff) , if hypotension persists then IV Ephedrine 6 mg boluses will be given . All patients will receive preloading 200ml crystalloids prior to induction of anesthesia .

Study Timeline

• Study Start: 2021-06-26
• Study First Submitted: 2022-09-14
• Study First Submitted QC: 2022-09-21
• Study First Posted: 2022-09-22
• Primary Completion: 2022-12-30
• Status Verified: 2023-01
• Study Completion: 2023-01-10
• Last Update Submitted: 2023-01-17
• Last Update Posted: 2023-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Patients belonging to ASA Grade I,II,III
• For major Oncosurgery under general anaesthesia

Exclusion Criteria

• Patient refusal
• BMI>30
• Emergency surgery
• Preoperative Hypotension MAP < 70 mmHg
• LVEF<40%
• Difficult Airway
• Nasal Intubation
• Inability to obtain good ultrasound images of SCV and IVC .

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ultrasound guided Superior Vena Cava Collapsibility Index (SVC - CI)	Ultrasound guided Superior Vena Cava Collapsibility Index	Preoperative ultrasound guided Superior Vena Cava collapsibility Index will be measured with patient breathing spontaneously and on deep inspiration.
Ultrasound Guided Inferior Vena Cava Collapsibility Index (IVC -CI)	Inferior Vena Cava Collapsibility Index	Preoperative Ultrasound guided Inferior Vena Cava collapsibility Index will be measured with patient breathing spontaneously and on deep inspiration.

Primary Outcome Measures

Name	Time	Method
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	30 minutes prior to induction of 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.

Secondary Outcome Measures

Name	Time	Method
To evaluate the sensitivity of SVC -CI and IVC -CI as a predictor of hypotension after induction of General anesthesia .	30 minutes prior to induction of anaesthesia	Preoperative US Guided SVC-CI in percentage and IVC -CI in percentage values will be obtained and statistical analysis will be done

Trial Locations

Locations (1)

Rajiv Gandhi Cancer Institute and Research Centre; 🇮🇳 New Delhi, Delhi, India