Comparison of Conventional Fluid Management Protocol With Targeted Pleth Variability Index (PVI) Monitoring Protocol During Total Abdominal Hysterectomy and Bilateral Salpingooferectomy Operation

NCT04775576 | Completed DMC

• 1 other identifier: 2020/514/172/4
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to compare the volume management methods performed by using conventional method and PVI monitoring in intraoperative fluid treatment during bilateral salpingo-oophorectomy and total hysterectomy operation.

Conditions

Intraoperative Hypotension; Intraoperative Complications; Hypervolemia; Acute Renal Failure; Perioperative/Postoperative Complications; Volume Overload

Outcome Measures

Primary Outcomes (1)

• compare the control group (conventional fluid management) with the PVI group (Pleth Variability Index and SpHb guided targeted fluid management) protocol.

  compare the amount of crystalloids,colloids and blood products, blood lactate, serum creatinine and electrolyte levels applied in the intraoperative period as a result of both protocols.

  0-180 minute

Secondary Outcomes (3)

• Postoperative length of stay in hospital

  24 hours

• Postoperative kidney injury

  24 hours

• Postoperative Lung complications

  24 hours

Study Arms (2)

Group 1

ACTIVE COMPARATOR

This group will have fluid theraphy due to conventional methods. The participants in this group will have 8-10 ml/kg/hour cristalloid infusion. If the mean arterial pressure (MAP) is \<65 mmHg or the decrease in MAP is more than 20%, 250 ml iv colloid will be applied. If the decrease in MAP continues despite the colloid bolus or if the MAP is below 65 mmHg, noradrenaline infusion will be started.

Other: Conventional fluid theraphy; Other: Anesthesia method

Group 2

ACTIVE COMPARATOR

Patients in the PVI group will be started on maintenance fluid therapy at 2-3 ml / kg / hour. In addition to standard monitoring, if PVI is \<13% and OAB≥65mmHg in measurements made with PVI, current fluid therapy will continue. If PVI is \<13% and MAP \<65 mmHg, noradrenaline infusion will be started. If PVI is\> 13% and OAB≥65 mmHg, 250 ml iv colloid bolus will be administered, and iv colloid bolus will be continued until the PVI is \<13% in the 5-minute follow-ups. If PVI\> 13% and MAP \<65 mmHg, patients should receive 250 ml i.v. colloid infusion will be given, if MAP \<65mmHg continues in 5 minutes follow-up, 250 ml i.v. Colloid and noradrenaline infusion will be started and repeated until the OAB≥65 mmHg and PVI \<13%.

Other: Pleth Variability Index; Other: Anesthesia method

Interventions

Pleth Variability Index OTHER

Conventional fluid management is widely used in clinical practice. In this method, the fluid need of the patient is decided according to pulse, arterial blood pressure, central venous pressure, urine output and clinical condition. In the targeted fluid therapy method, besides static parameters such as pulse, arterial blood pressure, central venous pressure; Dynamic parameters such as Stroke volume variability (SVV), pulse pressure variability (PPV), pleth variability index (PVI), continuous hemoglobin (SpHb) are also used noninvasively.

Group 2

Conventional fluid theraphy OTHER

8-10 ml / kg / hour iv fluid maintenance will be started for the control group. If the mean arterial pressure (MAP) is \<65 mmHg or the decrease in MAP is more than 20%, 250 ml iv colloid will be applied. If the decrease in MAP continues despite the colloid bolus or if the MAP is below 65 mmHg, noradrenaline infusion will be started.

Group 1

Anesthesia method OTHER

All patients included in the study will be premedicated with 1mg of midazolam after monitoring with pulse, non-invasive blood pressure, oxygen saturation. Then, invasive arterial cannulation will be applied and continuous blood pressure monitoring will be done. In the PVI group, non-invasive PVI and SpHb monitoring will also be performed from the other upper extremity without arterial cannulation. After two minutes of preoxygenation, anesthesia induction will be started. Anesthesia induction doses used routinely in our clinic include iv 2 mg / kg propofol, 0.6 mg / kg rocuronium and 2 μg / kg fentanyl. Sevoflurane will be administered by inhalation during anesthesia maintenance after tracheal intubation.

Group 1; Group 2

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: total abdominal hysterectomy and bilateral salpingooferectomy operation
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Total abdominal hysterectomy and bilateral salpingooferectomy operation is planned Patients in the ASA 1-2-3 group

You may not qualify if:

• Under 18 years old Severe cardiac arrhythmia Ejection fraction ≤ 30% Acute and / or chronic renal failure Patients who need more than 8ml / kg tidal volume due to advanced stage COPD

Sponsors & Collaborators

• Dr. Lutfi Kirdar Kartal Training and Research Hospital: lead

Study Sites (1)

Kartal Dr. Lutfi Kırdar City Hospital

Istanbul, 34865, Turkey (Türkiye)

Location

Related Publications (6)

• Holte K, Sharrock NE, Kehlet H. Pathophysiology and clinical implications of perioperative fluid excess. Br J Anaesth. 2002 Oct;89(4):622-32. doi: 10.1093/bja/aef220. No abstract available.

  PMID: 12393365 BACKGROUND

• Nisanevich V, Felsenstein I, Almogy G, Weissman C, Einav S, Matot I. Effect of intraoperative fluid management on outcome after intraabdominal surgery. Anesthesiology. 2005 Jul;103(1):25-32. doi: 10.1097/00000542-200507000-00008.

  PMID: 15983453 BACKGROUND

• Raikhel M. Accuracy of noninvasive and invasive point-of-care total blood hemoglobin measurement in an outpatient setting. Postgrad Med. 2012 Jul;124(4):250-5. doi: 10.3810/pgm.2012.07.2584.

  PMID: 22913913 BACKGROUND

• Miller RD, Ward TA, Shiboski SC, Cohen NH. A comparison of three methods of hemoglobin monitoring in patients undergoing spine surgery. Anesth Analg. 2011 Apr;112(4):858-63. doi: 10.1213/ANE.0b013e31820eecd1. Epub 2011 Mar 8.

  PMID: 21385985 BACKGROUND

• Doherty M, Buggy DJ. Intraoperative fluids: how much is too much? Br J Anaesth. 2012 Jul;109(1):69-79. doi: 10.1093/bja/aes171. Epub 2012 Jun 1.

  PMID: 22661747 RESULT

• Arieff AI. Fatal postoperative pulmonary edema: pathogenesis and literature review. Chest. 1999 May;115(5):1371-7. doi: 10.1378/chest.115.5.1371.

  PMID: 10334155 RESULT

MeSH Terms

Conditions

Intraoperative Complications; Edema; Acute Kidney Injury; Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiology and Reanimation Specialist

Study Record Dates

• First Submitted: February 25, 2021
• First Posted: March 1, 2021
• Study Start: February 25, 2021
• Primary Completion: July 12, 2021
• Study Completion: July 12, 2021
• Last Updated: July 13, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR

Locations

TU (1)