Basic Hemodynamic Monitoring Reliability During Percutaneous Nephrolithotomy.

NCT03828175 | Completed

• 1 other identifier: • MFM-IR.18.03.103 on 5/5/201
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective pre and post-quasi-descriptive single group interventional study will be done at urology and nephrology center -Mansoura University during the year 2019, for a 3-month duration, starting 1-2-2019 till 1-4-2019 after approval of IRB (Institutional Review Board) code no R/18.03.103 on 5/5/2018, Mansoura Faculty of Medicine. correlating Basic hemodynamics with noninvasive cardiac output for diagnostic reliability during percutaneous nephrolithotomy hidden bleeding under spinal anesthesia

Conditions

Renal Stone

Keywords

Cardiac output, Hemodynamic, Monitoring, Percutaneous.

Outcome Measures

Primary Outcomes (1)

• Stroke volume index (SVI)

  continuous stroke volume index (stroke volume divided by the body weight) during prone position spinal anesthesia

  up to 120 minutes.

Study Arms (1)

cop variables

OTHER

non invasive cop vsriables correlation to basic monitoring variables during prone position spinal anesthesia intervention pcnl operation at basic ,1hour and 2hours .

Procedure: spinal anesthesia monitoring

Interventions

spinal anesthesia monitoring PROCEDURE

After attaching all standard monitors (ECG, NIBP, pulse oximeter) and the COP bio-impedance monitor recording basal data (COP, CI, SV, CPI, Do2, DO2I, SVR, SVV. During sitting position intrathecal anesthesia was conducted in the sitting position under complete aseptic condition using heavy bupivacaine 15mg (3ml) plus 10 mic dexamedatomedine 25G needle after 2 ml Lidocaine skin infiltration. lithotomy position till anesthesia level documented T4 and fixed and lower urinary tract endoscopy then shifting the patient to prone position and after adjustment of the prone position precautions 2 bellows one under the chest and one under the pelvis with pliable free moving abdomen jell ring under the patient head knees and in front of heels, then the basal data recording and after that data recording every 10 minutes till end of the operative procedure. Blood sampling at basal, postoperative

cop variables

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled for percutaneous nephrolithotomy endoscopic operation
• ASA I-III.
• Both sexes,
• Age 18 - 70 years.
• PCNL operation time ≥120 minutes.

You may not qualify if:

• Patient refusal.
• PCNL operation time \<120 minutes.
• Hypersensitivity to amide local anesthetics.
• General contraindications to spinal anesthesia, coagulopathy.
• Cardiac, hepatic, renal or respiratory failure.
• Difficult communication.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University, Faculty of Medicine

Al Mansurah, DK, 050, Egypt

Location

MeSH Terms

Conditions

Nephrolithiasis

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor os anesthesia ICU & Pain medicine.

Study Record Dates

• First Submitted: January 29, 2019
• First Posted: February 4, 2019
• Study Start: February 1, 2019
• Primary Completion: April 1, 2019
• Study Completion: April 5, 2019
• Last Updated: April 29, 2019

Record last verified: 2019-04

Locations

EG (1)