AIM:

Aim of study is to compare hemodynamics parameters in patients undergoing percutaneous nephrolithotomy (PNCL) under combined Spinal epidural and General anaesthesia (GA) in a tertiary referral hospital.

   PRIMARY OBJECTIVE:

       Primary objective is to compare Pulse rate, Mean arterial pressure, ABG in patients undergoing percutaneous nephrolithotomy.

 SECONDARY OBJECTIVES:

Secondary aim is to compare blood loss, duration of postoperative analgesia in patients undergoing percutaneous nephrolithotomy.

MATERIALS & METHODS:

 Location:

 Urology Operation theatre in SRM MCH.

 Study duration:

             1 1/2 years (2021-22)

Study design:

              Prospective, Randomized controlled trial

 Method of randomization:

               Random number generation by computer in sealed envelope technique.

 SAMPLE SIZE:

Sample size is calculated based on primary outcome of the study done by  Gholamreza Movasseghi.

Study sample size – Z(Zα+Z 1-β)² ( S1²+S2²) ÷(m₁-m₂)²

^{S1= 151.1                                                          m}₁₌^331.7   

^{S2= 89.6                                                            m}₂₌^211.03

^{20.99 ( 22831+8028) ÷14561 =44.4              sample size = 45}

STUDY POPULATION:

All patients undergoing ASA(I/II) who are undergoing PCNL under general anesthesia or combined spinal epidural anesthesia.

 INCLUSION CRITERIA:

Patients between 18-65 years with physical status I or II of American Society of Anesthesiologists (ASA) undergoing PCNL.

 EXCLUSION CRITERIA:

·       All patients with spinal deformity

·       Local infection at injection site

·        History of any neuromuscular or psychiatric disorder or chronic pain Hypertension, diabetes and coagulation disorders

·       Patients with hypersensitivity to local anaesthetics, substance abusers.

·       Patients with solitary kidney

·       Patients posted for bilateral PCNL

METHODOLOGY:

CONSENT

·       After obtaining the institutional ethics committee approval, this study will be conducted on patients undergoing surgeries of PCNL. The written, informed consent will be obtained from all the patients.

GA group:

·       Patients will be premedicated with Inj.Fentanyl 2mcg/kg and Inj.Midazolam 0.01-0.02 mg/kg. Oxygen with an inspired fraction of 1.0 will be administered for 3 min before intubation.

·       Then, GA will be induced with Inj.Propofol 2mg/kg, and trachea was intubated with Inj.Atracurium 0.5mg/kg. All patients were changed to prone position after ensuring stable MAP.

 GA was maintained with 50% O2 and 50% N2O and 2% sevoflurane.

·       The ventilation protocol consisted of an inspired   oxygen fraction of 0.5, inspiratory to expiratory ratio of 1:2, and a respiratory rate adjusted to normocapnia .

·       Mechanical ventilation has been set with a tidal volume of 8 ml/kg ideal body weight (IBW) and ZEEP (zero-positive end expiratory pressure). Atracurium and fentanyl re-administration is based on train-of-four (TOF) and every 45 minutes, respectively.

·       Patient will be monitored for hemodynamic changes every 5 minutes. Arterial blood gas analysis will be done preoperative and postoperatively

·       Mean arterial pressure below 80 mmHg or 20% from the baseline is corrected by 6 mg ephedrine and crystalloids, and all PR descents less than 60/min will be treated by intravenous Atropine.

·       At the end of the procedure, patient will be changed back to supine position and then neuromuscular blockade will be reversed. Once the patient met the extubation criteria ,patient will be extubated and observed in the recovery room.

 CSE GROUP:

·       Premedication of 0.01-0.02 mg/kg from midazolam will be administered. The patients are placed in a sitting position.

·       Epidural anesthesia will be performed with patient in sitting position in  T11-T12 interspace. Epidural space will be confirmed by LOR to air. Catheter tip will be secured at T8 and test dose will be administered.

·       Spinal anesthesia will be administered with patient in sitting position using 25-gauge Quincke needle in L3-L4 or L4-L5 level with intra-thecal 15-20 mg of 0.5% hyperbaric  bupivacaine.

·       Sensory blockade is evaluated by a cotton (for temperature perception) or a needle (for pain) every 15-20 seconds; then, motor blockade is assessed by Bromage scale with following score: 0 = no paralysis; 1 = inability to raise extended leg; 2 = inability to flex knee; 3 = inability to move leg joints.

·       Patient is monitored for 15-20 mins for any hemodynamic change and changed to prone position.

·       Mean arterial pressure below 80 mmHg or 20% from the baseline is corrected by 6 mg ephedrine and crystalloids, and all PR descents (less than 60/min) will be treated by intravenous Atropine.

·       If sensory level regresses below T10, epidural topup will be done with 5ml of 0.25% bupivacaine every 40 minutes.

·       At the end of the procedure , patient will be changed to the supine position and the level of blockade is reassessed. Patient will be observed in the recovery room until sensory level regresses below L1.

·       In both the groups , blood loss will assessed by calculating blood volume of suction devices, and estimated volume of blood in sponges and drapes that were already weighted before operation.

·       Post operative pain was monitored with visual analogue score and patients were administered Inj.Paracetemol 1gm IV and Inj.Tramadol 100mg IV if VAS >4 .

STATISTICAL ANALYSIS

Descriptive statics (mean, standard deviation, and frequency) will be included. To compare quantitive data, chi-square test will be used. The results will be expressed    in 95% confidence interval .A value of p<0.05 will be considered to be statistically significant. Statistical analysis will be done using SPSS software.