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PVI Based Intraoperative Fluid Management in Head and Neck Free Flap Reconstructive Surgeries

NCT03116178 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2017-04-14

No results posted yet for this study

Summary

Intraoperative fluid given according to BMI in group B and according to pulse oximeter- derived pleth variability index(MASIMO RAINBOW PULSE CO OXIMETRY) in group G. Comparison of haemodynamics, urine output,blood lactate levels, blood sugar, flap sugar and coagulation profile between the two groups.

Conditions

  • Free Tissue Flaps

Interventions

OTHER

Group G -PVI( Masimo co oximeter) guided fluid therapy

goal directed fluid therapy maintaining pvi 4-11. when pvi\<4 fluid rate is 50-60ml/hr and pvi\>11 200ml colloid bolus transfusion till pvi value achieves normal range. In the control group crystalloid was administered @ 6-8 ml/kg and blood loss was replaced by colloids. Hourly urine output was measured and if less than 0.5ml/hr bolus crystalloid 100-200ml was administered

OTHER

Group B- Body weight guided intravenous fluid @6-8ml/kg

Intravenous fluid @6-8ml.kg and blood loss replacement with colloids maintaining urine output of 0.5ml/kg

Sponsors & Collaborators

  • Rajiv Gandhi Cancer Institute & Research Center, India

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2016-10-31
Completion
2016-10-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03116178 on ClinicalTrials.gov