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A clinical trial to compare two methods of giving intravenous fluid therapy during the operation, conventional and goal directed, in major surgeries being carried out under general anaesthesia.

A comparative evaluation of goal directed and conventional intraoperative fluid therapy in major surgeries under general anaesthesia.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/02/023133
Enrollment
60
Registered
2020-02-05
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Goal Directed intraoperative fluid therapy: Intraoperative intravenous fluid administration guided by stroke volume variation obtained from minimally invasive cardiac output monitoring

Sponsors

Department of Anesthesiology and Intensive care Maulana Azad Medical college
Lead Sponsor

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

MeasureTime 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

MeasureTime 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

Public ContactDr Karthik K Raman

Maulana Azad Medical college

dramitkohli@yahoo.com9818073402

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026