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Principal Investigator:
Guide:
Review of Literature
Between 1% and 8% of TURP procedures are complicated by the TURP syndrome(3).
Significant hyponatremia has been reported following TURP in 11-41% of patients(4).
According to Hahn RG, absorption of small amount of fluid(1-2 litre) occurs in 5- 10% of
patients undergoing transurethral prostatic resection and results in an easily overlooked
mild transurethral resection syndrome(3). Even changes in serum sodium concentration
of >7 mmol/L and of >7% could predict the development of cardiovascular and
neurological manifestations (1).
The prevalence of Diabetes is increasing rapidly, and Type 2 Diabetes now accounts for
20 to 50% of cases of new-onset diabetes in young people(5). More than 62 million
people in India are diagnosed currently with Diabetes Mellitus(6). Increase in blood
glucose level significantly affect the serum sodium concentration. The null hypothesis is
that there is no significant difference between diabetic and nondiabetic group in the
incidence of hyponatremia.
Lacunae In Literature- We could not find any similar study of hyponatremia in TURP
surgery in diabetic patients.
Aim
To compare plasma sodium levels after TURP surgery in diabetic and non diabetic patients.
Objective
1) To assess the change in plasma levels of sodium after TURP surgery.
2) To compare the change in plasma levels of sodium between diabetic and nondiabetic
patients.
3) To compare the incidence of clinical manifestations of TURP syndrome in diabetic and
nondiabetic patients.
as restlessness, agitation, confusion, altered sensorium, seizure and coma, result from water
intoxication and dilutional hyponatremia, which collectively produce cerebral edema.
Cardiovascular effects reflect volume overload and hyponatremia.
Circulatory disorders
-Chest pain, bradycardia, hypertension, hypotension , poor urine output
Neurological disorders
-blurred vision, nausea , vomiting, uneasiness, confusion, tiredness, consciousness, headache.
The presence of at least one circulatory disorder and one neurological disorder is necessary for
a diagnosis of TURP syndrome(7).
Diabetes Mellitus- Diabetes Mellitus is a group of metabolic diseases characterised by
hyperglycemia, resulting from defects in insulin secretion, action or both.
Hypotension- Hypotension is defined as >20% decrease in systolic blood pressure from the
baseline.
Sample size
The sample size was calculated by nMaster sample size calculation software using the
prevalence from the study by H Krishna Moorthy, Shobha Philip. Serum Electrolytes in TURP
Syndrome- Is the Role of Potassium underestimated? Indian J. Anaesth 2002;46(6): 441-444.It
is found out that for a precision of 10% and a confidence level of 95%, the sample size of 72
can be taken. So we decided to study on a total of around 75 consecutive patients undergoing
TURP surgery in the study period from January 2016 January2017
Study procedure
Patients are assessed one day prior to surgery and data regarding comorbidities and drugs are
collected. They are kept nil orally to solids for 6 hours prior to the surgery and pre medicated
with Tab. Ranitidine 150 mg and Tab. Ondansetron 4mg one hour before call to the operation
theatre. Preoperative fasting blood sugar and serum sodium are recorded along with other
routine investigations. Patients are shifted to the operation theatre and routine monitors such
as Noninvasive blood pressure(NIBP), Electrocardiogram(ECG), Percutaneous saturation
oxymetry(SPO2) are attached. Oxygen is administered via simple face mask (6L/min).
Balanced salt solution is used as maintenance fluid intraoperatively.
Under aseptic precautions, subarachnoid block is performed with 2.2ml 0.5% Bupivacaine
(Hyperbaric) and 20g Fentanyl to obtain a sensory block upto T10 level. Maximum sensory
level attained will be checked by pin prick method. If spinal anaesthesia is ineffective patient
will be removed from the study. The surgical procedure is done with 1.5%glycine as irrigation
fluid, keeping the irrigation fluid column at a height of 60cm, measured from the level of pubic
symphysis of the patients on the operating table. Monopolar resectoscope is used by the
surgeon.
The
saturation oxymetry, respiratory rate, duration of procedure, volume of irrigating fluid used,
volume of intravenous fluid and weight of resected prostate gland will be recorded. All
patients are carefully observed for early symptoms of TURP syndrome perioperatively and
severity graded with the checklist(Table 1) recommended by Hahn RG(4). Intraoperative
hypotension will be treated with IV fluids and/or Ephedrine 3-6mg IV boluses. Bradycardia
(HR<50/min) will be treated with IV Atropine 0.6mg boluses. Respiratory depression (RR <
8/min or SpO2 < 94%) will be treated with ventilatory assistance. Random blood sugar and
serum sodium will be measured one hour after the start of surgery and 4 hours
postoperatively.
Study design- Prospective observational study
Study duration-0ne year.
PROFORMA
Name:
Age:
Hospital No:
Diabetic:
Weight:
Non Diabetic:
Height:
Date of surgery:
Other comorbidities:
Time:
Duration of surgery:
Weight resected:
Data collection sheet
Variables
Recorded
(mins)
Pre
Op
10
15
20
25
30
35
40
45
50
55
60
70
80
90
100
HR (/min)
SBP
(mmHg)
DBP
(mmHg)
MAP
(mmHg)
RR (/min)
SP02 (%)
Midazolam:
Ondansetron:
Diuretics:
Pre operative
Plasma sodium
GRBS
Intra operative
Post operative
End
of
Sx
Severity Score
Neurological
Circulatory
Chest pain
Duration<5 min
Repeated attacks
Bradycardia
HR decrease
10-20 bpm
HR decrease
>20 bpm
Repeated decreases
Hypertension
SAP up
10-20 mm Hg
SAP up
>30 mmHg
Hypotension
SAP down
30-50 mmHg
SAP down
>50mm Hg
Repeated
drops>50mm Hg
Poor urine
output
Diuretics are
needed
Repeated use
Diuretics ineffective
Blurred vision
Transient blindness
Nausea
Duration<5 min
Vomiting
Single instance
Repeatedly, >60
min
Uneasiness
slight
moderate
Intense
Confusion
Duration<5 min
Tiredness
Patient says so
Objectively exhausted
Consciousness
Mildly depressed
Somnolent<60 min
Needs ventilator
Headache
Mild
Severe<60 min
Statistical Analysis
The categorical variables will be compared with Chi square test and the values expressed as
mean will be compared with students t test.
Ethical considerations
Approval from institutional ethics committee.
Written informed consent will be obtained from every participant.
Participant information will be kept confidential
References
1. Ishio J, NakahiraJ, Sawai T, Inamoto T, Fujiwara A, Minami T. Change in serum sodium
level predicts clinical manifestations of transurethral resection syndrome: a
retrospective review. BMC Anesthesiol. 2015 Apr 16;15(1):52.
2. Palmer BF, Clegg DJ. Electrolyte and Acid-Base Disturbances in Patients with Diabetes
Mellitus. N Engl J Med. 2015 Aug 6;373(6):548-59.
3. Hahn RG. Fluid absorption in endoscopic surgery. Br J Anaesth. 2006 Jan;96(1):8-20
4. Goel CM, Badenoch DF, Fowler CG, Blandy JP, Tiptaft RC : Transurethral resection
syndrome- a prospective study. Eur. Urol. 1992;21(1): 15-7.
5. National diabetes statistics report:estimates of diabetes and its burden in the United
States,2014. Atlanta: Centers for Disease Control and Prevention, 2014.
6. Kumar A, Goel MK, Jain RB, Khanna P, Chaudhary V. India towards diabetic control: Key
issues. Australas Med J. 2013;6(10):524-31.
7. Nakahira J, Sawai T, Fujiwara A, Minami T. Transurethral resection syndrome in elderly
patients: a retrospective observational study. BMC Anesthesiol. 2014 Apr 23;14(1):30
The study that you have been requested to be a part of is titled Plasma sodium levels after TURP
surgery in diabetic patients in comparison with non diabetic patients- a cross sectional study. The
study is aimed at improving the medical care and providing valuable informations about electrolyte
changes in patients like you undergoing Transurethral Resection of Prostate under spinal anaesthesia.
This is an observational study to compare the incidence of hyponatremia in diabetic and non diabetic
patients undergoing this surgery. In diabetic patients, increase in blood glucose level can lead to
change in the blood level of sodium. The use of irrigating fluid can lead to many neurological and
circulatory disturbances. By assessing blood level of sodium and glucose, we will be able to detect the
changes early and provide you the best possible care.
All patients enrolled in this study will be evaluated for glucometer random blood sugar and sodium
levels preoperatively, intraoperatively and postoperatively along with other routine preoperative
investigations. All patients will receive the standard care. All the data collected including your
personal information will be kept strictly confidential and may only be examined by the Principal
Investigator/Guide/Study Regulatory Authority of the institution.The cost of extra investigation shall
be borne by the primary investigator.
Your participation in this study would provide important knowledge whereby we could improve
patient care.If you still have any queries regarding this study, you may please contact us at the details
provided below.
Principal Investigator: Dr. Allwyn Thomas
Post Graduate Student
Dept. of Anaesthesiology
Ph: 9048007547
Guide:
Dr.Sara Korula
Professor
Dept. of Anaesthesiology
Ph:9446596066
INFORMED CONSENT
I hereby give consent to participate in the research study Plasma sodium levels after TURP
surgery in diabetic patients in comparison with non diabetic patients- a cross sectional study to be
conducted in MOSC Medical College Hospital, Kolenchery.
I have been briefed on the foregoing research conducted by Dr.Allwyn Thomas and Dr. Sara
Korula in my own language. I have had the opportunity to clarify my concerns to my
satisfaction regarding the research. I consent voluntarily to participate in this research,
knowing that I have the right to withdraw from it at any time without affecting my medical
care.
Name of participant:
Signature of participant:
Date (dd/mm/yy): ..