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Comparing two methods of giving the drug propofol for making the patient sleep

Target Controlled Infusion: A Comparative prospective observational study of the Conventional TCI pump and the new smartphone based application iTIVATM - TACITIVA

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2019/11/022076
Enrollment
55
Registered
2019-11-20
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C509- Malignant neoplasm of breast of unspecified site

Interventions

Intervention1: Nil: Nil Control Intervention1: Nil: Nil

Sponsors

Rajiv Gandhi Cancer Institute and Research Centre
Lead Sponsor
Dr Rajiv Chawla
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Weight 40-80kg ASA physical status I and II Patients undergoing breast cancer surgery

Exclusion criteria

Exclusion criteria: Patients who do not give consent Allergy to propofol

Design outcomes

Primary

MeasureTime frame
Volume of propofol in millilitre given by iTIVA TCI smartphone applicationTimepoint: 3min,10min,25min,45min,90min as per the Schneider pharmacokinetic model

Secondary

MeasureTime frame
Volume of propofol in millilitre given by Injectomat Agilia conventional TCI pumpTimepoint: 3min,10min,25min,45min,90min as per the Schneider pharmacokinetic model;Heart rateTimepoint: 3min,10min,25min,45min,90min as per the Schneider pharmacokinetic model;Mean arterial pressureTimepoint: 3min,10min,25min,45min,90min as per the Schneider pharmacokinetic model

Countries

India

Contacts

Public ContactDr Shagun Bhatia Shah

Rajiv Gandhi Cancer Institute and Research Centre

shah.shagun@rgcirc.org9891769779

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Apr 4, 2026