se of Inj. Clonidine to reduce use of painkillers during surgery and to reduce blood loss.

Phase 2

Completed

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

• Registration Number: CTRI/2019/10/021505
• Lead Sponsor: HCG Manavata Cancer Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2020-03-10
• Last Update Posted: 1 May 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 80

Inclusion Criteria

1.Operable Breast Cancer Patients undergoing Breast Conservation Surgery in Adjuvant and Neoadjuvant setting.

2.Age 18 yrs â?? 80 yrs

3.Patientâ??s ASA between I â?? III

4.ECOG Performance Status < 0 â?? 2

5.Estimated Life Expectancy > 6 months based on clinical evaluation by the Investigator.

6.No persistent toxicities from prior medications at screening.

7.Able to comply to study requirement in opinion of Investigator.

8.Hematology, Sr. Creatinine and R BSL within Normal Limits

9.Negative Pregnancy tests in sexually active women

10.Patient able to understand and provide written informed consent prior to participation in the study.

Exclusion Criteria

1.Uncontrolled DM with Autonomic Dysfunction

2.Uncontrolled HTN

3.IHD

4.Heart Block

5.Patients on Beta Blockers

6.History of CVA or DVT within last 3 months.

7.Pregnant or Breast Feeding Women

8.Hypersensitivity to Inj. Clonidine, Inj. Labetelol, Inj. Fentanyl.

9.Active Opprtunistic Infections.

10.Impaired Cardiac Function within last 6 months.

11.Drug Abuse â?? Tobacco, Alcohol or any other recreational drugs

12.Positive or reactive test for HIV, HAV, HCV or HBsAg

13.Receipt of any other IP or participation in other drug trial within 30 days or 5 half lives , whichever is greater, prior to receiving drug in this study.

14.Any other primary tumours.

15.Other serious illness that would prohibit understanding and giving informed consent.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Blood loss, Need of Analgesia.Timepoint: At the End of Study

Secondary Outcome Measures

Name	Time	Method
Achievement of MAP 60-70 mm of Hg or % reduction in MAPTimepoint: At the End of Study