I am going to perform breast surgery under spinal anaesthesia and want to show the benefits of spinal anaesthesia over general anaesthesia

Comparative Assessment of Intra-operative Hemodynamic Stability in General Anaesthesia versus Segmental Thoracic Spinal Anaesthesia for Modified Radical Mastectomy – A randomized, prospective and controlled study - NIL

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/11/060363

Enrollment

100

Registered

2023-11-30

Start date

Unknown

Completion date

Unknown

Last updated

2023-12-19

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 Health Condition 2: C509- Malignant neoplasm of breast of unspecified site

Interventions

Intervention1: Thoracic segmental spinal anaesthesia at T5-T6 level.: We will compare Hemodynamic stability , satisfaction score in thoracic segmental spinal anaesthesia as compare to general anaesthe

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients of ASA physical status I and II 2. Patients between 18-60 years of age 3.Posted electively for modified radical mastectomy (MRM)

Exclusion criteria

Exclusion criteria: 1. Patients refusal 2. Any contraindicating spinal anesthesia, 3. Inflammatory breast cancer, 4. Previous surgery for breast cancer except for diagnostic lumpectomy, 5. Obese patients (Body mass index above 35kg/m2)

Design outcomes

Primary

Measure	Time frame
Primary objective- to assess the hemodynamic stability in both groups. Hemodynamic stability will be defined as changes in MAP within 30% of the baseline value or/and HR >60/min and <100/minTimepoint: We will monitor vitals every 5 minutes intraoperative	—

Secondary

Measure	Time frame
i. To compare the incidence of side effects, ii. To compare patient satisfaction scores, and iii. To compare the cost-effectiveness of both anaesthetic techniques. Timepoint: Intraoperative 5 minutes and postoperative	—

Countries

India

Contacts

Public ContactAlok Kumar

Indira Gandhi Institute Of Medical Sciences, Patna

alok101kumar@gmail.com7992454344

Outcome results

None listed

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