Effects of Isotonic Saline As Irrigation Fluid In Transurethral Resection of Prostate (TUR-P) Operations

Anesthesia Clinical Trial

Official title:

The Effects of Isotonic Saline as Irrigation Fluid on Serum Electrolytes and Blood Gases in Bipolar Transurethral Resection of Prostate (TUR-P) : A Prospective Observational Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05285189
• Other study ID #: 2018/1378
• Status: Recruiting
• Start date: January 1, 2019
• Est. completion date: July 31, 2022

Study information

• Verified date: March 2022
• Source: Istanbul University
• Contact: Sabiha Basari, MD
• Phone: +905446616686
• Email: sabihabasari0[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Benign hypertrophy of the prostate (BPH) is a disease seen in 20% of men over the age of 50 and in 40% of those over the age of 70. The gold standard in the treatment of BPH is transurethral resection of the prostate using high-frequency diathermy. Today, this process is done with the bipolar technique, in which isotonic saline (isotonic sodium chloride %0.9) is used as the irrigation fluid. This irrigation fluid, which is used after long operation and deep tissue resection, can enter the systemic circulation through the opened venous sinuses.

It has been shown in clinical studies that postoperative acute hyperchloremia (serum Cl level > 110 mmol/L) develops after the use of intravenous normal saline solution in large amounts in the perioperative period.

Our aim is to detect hyperchloremia and associated metabolic acidosis without anion gap in the follow-up of these patients. Our primary hypothesis in this study is that hyperchloremic metabolic acidosis will develop due to the high amount of normal saline used in TUR-P.

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Description:

Benign hypertrophy of the prostate (BPH) is a disease seen in 20% of men over the age of 50 and in 40% of those over the age of 70. The gold standard in the treatment of BPH is transurethral resection of the prostate using high-frequency diathermy. Today, this process is done with the bipolar technique, in which normal saline (isotonic sodium chloride %0.9) is used as the irrigation fluid. In bipolar TUR-P, resection is performed using 25000 - 30000 ml normal saline for irrigation. This irrigation fluid, which is used after long operation and deep tissue resection, can enter the systemic circulation through the opened venous sinuses.

It has been shown in clinical studies that postoperative acute hyperchloremia (serum Cl level > 110 mmol/L) develops after the use of intravenous normal saline solution in large amounts in the perioperative period. McCluskey et al. found that 30-day mortality, prolonged hospital stay, and postoperative renal dysfunction developed in patients who received perioperative intravenous normal saline and subsequently developed acute hyperchloremia. Megan E. et al. Scheingraber et al. reported that the use of normal saline increases the risk of acidosis and kidney damage, also compared Ringer's lactate and normal saline infusion in patients who underwent gynecological surgery and showed that hyperchloremic metabolic acidosis developed in normal saline group. Excessive and rapid administration of normal saline solution by parenteral route causes hyperchloremic metabolic acidosis, which adversely affects the organism. According to recent studies, the development of hyperchloremic metabolic acidosis increases the cost and mortality, prolongs the hospitalization period, and causes renal dysfunction.

Our aim is to detect hyperchloremia and associated metabolic acidosis without anion gap in the follow-up of these patients. Our primary hypothesis in this study is that hyperchloremic metabolic acidosis will develop due to the high amount of normal saline used in TUR-P.

The investigators expect that an increase in the amount of fluid, prolongation of the operation time, and capsule perforation will increase hyperchloremia and deepen metabolic acidosis. If it causes hyperchloremic metabolic acidosis, the contribution of the amount of irrigation fluid or the duration of the operation can be determined, and the maximum amount of fluid that does not adversely affect the organism and the duration of the operation can be predicted.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: July 31, 2022
• Est. primary completion date: July 29, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male gender

• Having had a TUR-P operation

• Using of bipolar technic

• American Society of Anesthesiology (ASA) grade I-III

• Receiving patients consent

Exclusion Criteria:

• Failure to record preoperative and postoperative blood gas data

• Patient refusal

Related Conditions & MeSH terms

• Acidosis
• Anesthesia
• Normal Anion Gap Metabolic Acidosis
• Transurethral Resection of Prostate

Locations

Country	Name	City	State
Turkey	Istanbul University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Barker ME. 0.9% saline induced hyperchloremic acidosis. J Trauma Nurs. 2015 Mar-Apr;22(2):111-6. doi: 10.1097/JTN.0000000000000115. Review. — View Citation

Dombre V, De Seigneux S, Schiffer E. [Sodium chloride 0.9%: nephrotoxic crystalloid?]. Rev Med Suisse. 2016 Feb 3;12(504):270-2, 274. French. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum Chlorid level	Chlorid level is evaluated with blood gas analysis 3 times in total, at the beginning of the operation, at the 40th minute of the operation and 1st hour of arrival in post-anesthesia care unit.	Up to 4 hours
Secondary	Serum anion gap level	It is evaluated with blood gas analysis 3 times in total, at the beginning of the operation, at the 40th minute of the operation and 1st hour of arrival in post-anesthesia care unit.	Up to 4 hours
Secondary	Serum lactate level	It is evaluated with blood gas analysis 3 times in total, at the beginning of the operation, at the 40th minute of the operation and 1st hour of arrival in post-anesthesia care unit.	Up to 4 hours
Secondary	Presence&absence of capsule perforation during the operation	Effect of capsule perforation on hyperchloremia	Up to 4 hours
Secondary	Amount of prostate tissue resected during the operation	The effect of the amount of prostate tissue resected during the operation on hyperchloremia.	Up to 4 hours
Secondary	Amount of used normal saline for irrigation during the operation	The effect of the amount of used normal saline for irrigation during the operation on hyperchloremia.	Up to 4 hours
Secondary	Duration of operation	The effect of operation time on hyperchloremia.	Up to 4 hours
Secondary	Incidence of postoperative acute kidney injury	AKI was diagnosed by an increase in serum creatinine concentration >50% from a baseline creatinine concentration measured within 48 hours prior to enrollment	Up to 48 hours
Secondary	Incidence of mortality rate	Mortality of the patients was screened retrospectively at 6 months postoperatively.	Up to 6 months
Secondary	Length of hospital stay	Length of patients hospital stay was screened retrospectively at 1 week postoperatively.	Up to 1 week
Secondary	Number of participants with urethral stricture	Diagnosis will be made by urethroscopy in patients with voiding complaints.	Up to 6 months
Secondary	Number of participants with urinary bladder hematoma	Urinary system ultrasound in patients with severe hematuria	Up to 1 week