Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03116178
Other study ID # RGCI ID:503/AN/ITC-02
Secondary ID
Status Completed
Phase N/A
First received November 11, 2016
Last updated April 13, 2017
Start date March 2016
Est. completion date October 2016

Study information

Verified date April 2017
Source Rajiv Gandhi Cancer Institute & Research Center, India
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

A sample size of 80 taken and computer generated random allocation done to divide the patients in two groups(40 each). Head and neck onco surgery patients undergoing resection and reconstruction with radial artery free flap and antero lateral thigh free flap of duration 4-6 hours taken for surgery.

Group B to receive intravenous fluid according to body weight stating at the rate 6-8 ml/kg/hr.

Group G to receive intravenous fluid according to Pleth variability index value(4-11).Blood loss up to 10% replacement by colloids.

Comparison of following parameters:

Demography, haemodynamics,urine output .blood lactate, ph, oxygenation index ,thromboelastography (TEG), blood sugar, flap sugar .


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date October 2016
Est. primary completion date October 2016
Accepts healthy volunteers No
Gender All
Age group 25 Years to 65 Years
Eligibility Inclusion Criteria:

- All patients undergoing radial and anterolateral free flap

Exclusion Criteria:

- Duration of surgery > 6hrs

- BMI > 30

- Patients on anti platelet drugs

- Patient refusal

Study Design


Related Conditions & MeSH terms


Intervention

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
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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Rajiv Gandhi Cancer Institute & Research Center, India

References & Publications (2)

Forget P, Lois F, de Kock M. Goal-directed fluid management based on the pulse oximeter-derived pleth variability index reduces lactate levels and improves fluid management. Anesth Analg. 2010 Oct;111(4):910-4. doi: 10.1213/ANE.0b013e3181eb624f. Epub 2010 Aug 12. — View Citation

Yu Y, Dong J, Xu Z, Shen H, Zheng J. Pleth variability index-directed fluid management in abdominal surgery under combined general and epidural anesthesia. J Clin Monit Comput. 2015 Feb;29(1):47-52. doi: 10.1007/s10877-014-9567-5. Epub 2014 Feb 21. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in TEG waveform tracing as obtained from TEG 5000 Hemostasis analyser system The investigators hypothesize that the patients in group G receiving PVI (pleth variability index) guided fluid therapy will have normal TEG parameter (R,K, ALPHA, MA and LY30) values and the patients in group B may have abnormal TEG parameter values. six months
See also
  Status Clinical Trial Phase
Recruiting NCT05405179 - Simultaneous Dental Implant in Free Vascularized Bone Flaps for Jaw Reconstruction N/A
Completed NCT03330808 - Effect of Epidural Anesthesia on Blood Flow in Arterial Anastomosis of Free Flap N/A
Not yet recruiting NCT02604069 - Detection of Flap Ischemia Using Interstitial Glucose Monitor Phase 0
Recruiting NCT03118024 - Perioperative Management of DIEP Flaps N/A
Completed NCT02332161 - Leg Function and ADL After ALT Reconstruction for Head and Neck Cancer
Terminated NCT03579277 - Radial Forearm Versus the Ulnar Forearm Free Flap N/A