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

A

Ain Shams University

Status

Completed

Conditions

Postoperative Complications
First Time to Gastrointestinal Motion
Serum Lactate
Length of the Hospital Stay
Intestinal Edema
Intraoperative Fluid Volume
Hemodynamics

Treatments

Other: conventional fluid management
Device: pulse pressure variation

Study type

Interventional

Funder types

Other

Identifiers

NCT05502835
IRB00006379 GUT OEDEMA

Details and patient eligibility

About

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.

Full 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.

Enrollment

90 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

90 participants in 2 patient groups

conventional fluid management group
Experimental group
Description:
patients will do elective open colonic mass resection and anastomosis will receive Infusion of 6 ml/kg/hr. Ringer's solution.
Treatment:
Other: conventional fluid management
ppv group
Active Comparator group
Description:
patients will do elective open colonic mass resection and anastomosis. Infusion of 2 ml/kg/hr. Ringer's solution guided by pulse pressure variation.
Treatment:
Device: pulse pressure variation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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