Health Condition 1: O- Medical and Surgical
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Patients falling under the American society of anesthesiologists (ASA) physical status classes I and II scheduled to undergo elective major surgery under general anesthesia. Major surgery defined as per the National institute for health and care excellence (NICE) 2016 guidelines with estimated blood loss greater than 500 ml
Exclusion criteria
Exclusion criteria: 1. Pregnant females 2. Patients undergoing laparoscopic surgery 3. Patients with coagulopathy 4. Patients who are known cases of heart disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total intraoperative blood loss (ml) estimated from the intraoperative change in haematocrit.Timepoint: 1. Baseline haematocrit - Preoperatively before induction of anesthesia 2. Postoperative haematocrit - 1 hour after the end of surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| Intraoperative hemodynamic trends measured by 1. Mean arterial pressure trend during the intraoperative period 2. Number of hypotensive episodes 3. Vasopressor requirement and consumption: Whether vasopressor required and if yes, the total consumption in the intraoperative period in micrograms.Timepoint: Mean arterial pressure recorded at baseline (before induction of anesthesia) and then at 15 min intervals during the intraoperative period. Total number of hypotensive episodes and vasopressor requirement/consumption during the intraoperative period at the end of surgery;Postoperative pulmonary, renal, hepatic and coagulation functions: 1. Pulmonary function : Change in PaO2:FiO2 ratio measured from arterial blood gas analysis 2. Renal function: Intraoperative urine output(ml), postoperative serum creatinine(mg/dl)compared to preoperative baseline, post operative fractional excretion of sodium (%) 3. Hepatic function: Postoperative transaminase levels (SGPT and SGOT in IU) compared to preoperative baseline 4. Coagulation function: Postoperative INR Timepoint: PaO2:FiO2 ratio: 1. Baseline 2. 1 hr postoperatively Intraoperative urine output: Hourly during the intraoperative period Serum creatinine: 1. Baseline 2. 48 hrs postoperatively Fractional excretion of sodium: 48 hours postoperatively Transaminase levels: 1. Baseline 2. 48 hours postoperatively Postoperative INR: 1 hour postoperatively ;Tissue perfusion in the intraoperative period measured by plasma lactate levels (mmol/L).Timepoint: Baseline - Before induction of anesthesia Hourly measurements during the intraoperative period. 1 hour postoperatively.;Total intraoperative IV fluid requirement (ml)Timepoint: At the end of the surgery;Total perioperative blood product transfusion requirement measured as the total number of blood units transfused.Timepoint: 24 hours postoperatively | — |
Countries
India
Contacts
Maulana Azad Medical college