Clinical trial NCT05285189: Effects of Isotonic Saline As Irrigation Fluid In Transurethral Resection of Prostate (TUR-P) Operations
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hyperchloremic Acidosis
Transurethral Resection of Prostate
Normal Anion Gap Metabolic Acidosis
Anesthesia
Keywords: Blood gas analysis
TUR-P
Irrigation Fluid
Hyperchloremia
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2022-03-17
Enrollment: 75
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * Male gender who being prostate hyperplasia
* Having had a TUR-P operation
* Using of bipolar technic
* American Society of Anesthesiology (ASA) grade I-III
* Receiving patients consent

Brief 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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Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Serum Chlorid level
timeFrame: Up to 4 hours
Secondary outcomes:
measure: Serum anion gap level
timeFrame: Up to 4 hours
measure: Serum lactate level
timeFrame: Up to 4 hours
measure: Presence&absence of capsule perforation during the operation
timeFrame: Up to 4 hours
measure: Amount of prostate tissue resected during the operation
timeFrame: Up to 4 hours
measure: Amount of used normal saline for irrigation during the operation
timeFrame: Up to 4 hours
measure: Duration of operation
timeFrame: Up to 4 hours
measure: Incidence of postoperative acute kidney injury
timeFrame: Up to 48 hours
measure: Incidence of mortality rate
timeFrame: Up to 6 months
measure: Length of hospital stay
timeFrame: Up to 1 week
measure: Number of participants with urethral stricture
timeFrame: Up to 6 months
measure: Number of participants with urinary bladder hematoma
timeFrame: Up to 1 week
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University
Study officials:
affiliation: Istanbul University
name: Meltem Savran Karadeniz, Assoc.Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Barker ME. 0.9% saline induced hyperchloremic acidosis. J Trauma Nurs. 2015 Mar-Apr;22(2):111-6. doi: 10.1097/JTN.0000000000000115.
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.