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NCT Number: NCT05502835

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

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.

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Key information

Conditions

Intraoperative Fluid Volume First Time to Gastrointestinal Motion Hemodynamics Intestinal Edema Length of the Hospital Stay Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Serum Lactate

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ain shams university

Cairo, 20, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

pulse pressure variation

Device

Infusion of 2 ml/kg/hr. Ringer's solution guided by pulse pressure variation.

conventional fluid management

Other

Infusion of 6 ml/kg/hr. Ringer's solution.

Primary outcomes

  1. Intraoperative fluid volume

    Time frame: calculated immediately after surgery

Secondary outcomes

  1. intraoperative blood pressure

    Time frame: every ten minutes till the end of the surgery

  2. lactate level

    Time frame: every hour till the end of the surgery

  3. POSTOPERATIVE COMPLICATIONS

    Time frame: till one week after surgery

  4. intestinal oedema

    Time frame: intraoperatively after tumor resection

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 16, 2022
Registry last updated
Jan 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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