Ahmed Helmy1, Ahmed Mukhtar1, Abeer Ahmed2, Nazmy Edward Sief1, Amr Hussein1. 1. Anesthesia & SICU Department, Faculty of Medicine, Cairo University, Cairo, Egypt. 2. Anesthesia & SICU Department, Faculty of Medicine, Cairo University, Cairo, Egypt. Electronic address: abeer_ahmed@kasralainy.edu.eg.
Abstract
STUDY OBJECTIVE: This study was designed to evaluate the therapeutic equivalence of balanced 6% hydroxyethyl starch (HES) 130/0.4 (Tetraspan) vs saline-based 6% HES 130/0.4 (Voluven) regarding the volume effect and the effect on acid-base status and renal functions in patients undergoing major urologic procedures. DESIGN: Randomized comparative trial. SETTING: Operating room and ward. PATIENTS: Forty patients, American Society of Anesthesiologists statuses 1 and 2. INTERVENTION: Patients were randomly allocated to receive either Voluven (n = 20) or Tetraspan (n = 20). MEASUREMENTS: Hemodynamic variables. Laboratory variables in the form of arterial blood gases, serum chloride and sodium levels, hemoglobin level, international normalized ratio, and kidney and liver functions were measured after induction of anesthesia (T1), at the end of surgery (T2), and on the first postoperative day (T3). MAIN RESULTS: Both groups were comparable regarding the total amount of study drugs and crystalloid consumption. No significant difference in hemoglobin levels between both groups, but there were significant differences between T1 and T2 hemoglobin within both groups and T3 hemoglobin in the Tetraspan group. Both groups were comparable regarding the renal functions, but there was a significant difference between T1 and T2 creatinine within both groups. No significant differences between both groups in liver functions and coagulation profile, but there were significant differences between values at T1, T2 and T3 within each group. Relative to baseline, both pH and bicarbonate decrease significantly in both groups. In the Voluven group, bicarbonate decreased significantly at the end of surgery relative to the Tetraspan group. Serum electrolytes did not vary between both groups. CONCLUSION: Both balanced 6% HES 130/0.4 (Tetraspan) and saline-based 6% HES 130/0.4 (Voluven) were equally effective for hemodynamic stabilization of patients undergoing major urologic procedures without any significant impact on acid-base status or renal functions.
RCT Entities:
STUDY OBJECTIVE: This study was designed to evaluate the therapeutic equivalence of balanced 6% hydroxyethyl starch (HES) 130/0.4 (Tetraspan) vs saline-based 6% HES 130/0.4 (Voluven) regarding the volume effect and the effect on acid-base status and renal functions in patients undergoing major urologic procedures. DESIGN: Randomized comparative trial. SETTING: Operating room and ward. PATIENTS: Forty patients, American Society of Anesthesiologists statuses 1 and 2. INTERVENTION: Patients were randomly allocated to receive either Voluven (n = 20) or Tetraspan (n = 20). MEASUREMENTS: Hemodynamic variables. Laboratory variables in the form of arterial blood gases, serum chloride and sodium levels, hemoglobin level, international normalized ratio, and kidney and liver functions were measured after induction of anesthesia (T1), at the end of surgery (T2), and on the first postoperative day (T3). MAIN RESULTS: Both groups were comparable regarding the total amount of study drugs and crystalloid consumption. No significant difference in hemoglobin levels between both groups, but there were significant differences between T1 and T2 hemoglobin within both groups and T3 hemoglobin in the Tetraspan group. Both groups were comparable regarding the renal functions, but there was a significant difference between T1 and T2 creatinine within both groups. No significant differences between both groups in liver functions and coagulation profile, but there were significant differences between values at T1, T2 and T3 within each group. Relative to baseline, both pH and bicarbonate decrease significantly in both groups. In the Voluven group, bicarbonate decreased significantly at the end of surgery relative to the Tetraspan group. Serum electrolytes did not vary between both groups. CONCLUSION: Both balanced 6% HES 130/0.4 (Tetraspan) and saline-based 6% HES 130/0.4 (Voluven) were equally effective for hemodynamic stabilization of patients undergoing major urologic procedures without any significant impact on acid-base status or renal functions.
Authors: Nur Dyana Md Nizar; Shamsul Kamalrujan Hassan; Rhendra Hardy Mohamad Zaini; Mohamad Hasyizan Hassan; Wan Mohd Nazaruddin Wan Hassan; Mohd Zulfakar Mazlan Journal: Malays J Med Sci Date: 2020-12-29