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Effect of TIVA Propofol vs Sevoflurane Anaesthetic on Serum Biomarkers and on PBMCs in Breast Cancer Surgery

NCT03005860 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2023-12-21

No results posted yet for this study

Summary

Surgery, perioperative stress, anaesthetics and analgesics may modulate the immunosurveillance mechanisms and overwhelm host defences that normally maintain a balance between immunity \& carcinogenesis. This may lead to escape of cancer cells and tilt the scales toward a more protumorigenic microenvironment. Volatile agents, in particular, have been shown to exhibit profound immunosuppressive effects. In comparison, propofol has a favorable profile and inhibits cancer cell activity. Determining "cancer-protective" role of TIVA with propofol presents an exciting window of opportunity that has potential to improve outcomes in cancer patients undergoing resection surgery

Conditions

  • Female Breast Cancer

Interventions

DRUG

2,6-Diisopropylphenol

In Propofol group, anesthesia will be induced with Propofol TCI using Schneider model to achieve a target site concentration of 4 - 6 mcg/ml. Propofol TCI to achieve BIS (Bispectral Index) between 40-60.

DRUG

Fluoromethyl hexafluoroisopropyl ether

In Sevoflurane group, anesthesia will be induced with 5 - 7mg/kg thiopental, maintenance with O2 with air 50:50%, sevoflurane 2-2.5 %, Further fentanyl, in increments of 1 mcg/kg - and atracurium 0.15 mg/kg, will be given as indicated by the clinical signs and hemodynamic changes.

DRUG

Fentanyl Citrate

Inj. fentanyl 2 mcg/kg will be used as an adjunct during anaesthetic induction.

DRUG

Atracurium Besylate

Inj. atracurium 0.5 mg/kg for will be administered for facilitating LMA placement

Sponsors & Collaborators

  • Tata Memorial Centre

    lead OTHER

Principal Investigators

  • Shubhada Chiplunkar · Tata Memorial Centre

  • Rajan Badwe · Tata Memorial Centre

  • Anuja Bidkar · Tata Memorial Centre

  • Reshma Ambulkar · Tata Memorial Centre

  • Raghu Thota · Tata Memorial Centre

  • Vani Parmar · Tata Memorial Centre

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-01
Primary Completion
2020-10-31
Completion
2020-12-31

Countries

  • India

Study Locations

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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 NCT03005860 on ClinicalTrials.gov