Pulse Pressure Variation Based Intraoperative Fluid Management Versus Traditional Fluid Management for Colonic Cancer Patients Undergoing Mass Resection and Anastomosis

Not Applicable

Completed

• Conditions: Hemodynamics; First Time to Gastrointestinal Motion; Intraoperative Fluid Volume; Serum Lactate; Length of the Hospital Stay; Postoperative Complications; Intestinal Edema
• Interventions: Device: pulse pressure variation; Other: conventional fluid management

• Registration Number: NCT05502835
• Lead Sponsor: Ain Shams University

Brief Summary

pulse pressure variation based intraoperative fluid therapy versus traditional fluid therapy for colonic cancer patients undergoing mass resection and anastomosis for maintaining adequate hydration without complications.

Detailed Description

All Patients will be assigned randomly by using computerized program to one of the two equal groups. Patients will be (forty five patients per group):

Group A ;( control group) Forty five patients will do elective open colonic mass resection and anastomosis. Infusion of 6 ml/kg/hr. Ringer's solution.

Group B; Forty five patients will do elective open colonic mass resection and anastomosis. Infusion of 2 ml/kg/hr. Ringer's solution guided by pulse pressure variation.

Intraoperative fluid volume, hemodynamics, serum lactate and intestinal edema will be measured after induction of anesthesia and every hour till the end of the operation, length of the hospital stay, first time to gastrointestinal motion and postoperative complications are recorded.

Study Timeline

• Study First Submitted: 2022-08-02
• Study First Submitted QC: 2022-08-15
• Study First Posted: 2022-08-16
• Study Start: 2022-08-20
• Status Verified: 2023-01
• Primary Completion: 2023-01-20
• Study Completion: 2023-01-25
• Last Update Submitted: 2023-01-27
• Last Update Posted: 2023-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• American Society of Anesthesiologists physical status (ASA-PS) I and II Patients.
• Patients scheduled for elective open colonic mass resection and anastomosis.

Exclusion Criteria

• Serious cardiac arrhythmia.
• Peripheral artery disease.
• An ejection fraction below 30%.
• A pulmonary pathology.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ppv group	pulse pressure variation	patients will do elective open colonic mass resection and anastomosis. Infusion of 2 ml/kg/hr. Ringer's solution guided by pulse pressure variation.
conventional fluid management group	conventional fluid management	patients will do elective open colonic mass resection and anastomosis will receive Infusion of 6 ml/kg/hr. Ringer's solution.

Primary Outcome Measures

Name	Time	Method
Intraoperative fluid volume	calculated immediately after surgery

Secondary Outcome Measures

Name	Time	Method
intraoperative blood pressure	every ten minutes till the end of the surgery
lactate level	every hour till the end of the surgery
POSTOPERATIVE COMPLICATIONS	till one week after surgery
intestinal oedema	intraoperatively after tumor resection

Trial Locations

Locations (1)

Ain shams university; 🇪🇬 Cairo, Egypt