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A study to compare the effects of ondansetron and glycopyrrolate to prevent the fall in blood pressure and heart rate following spinal anaesthesia in patients undergoing lower limb orthopaedic surgery

A comparative study of prophylactic ondansetron and glycopyrrolate in prevention of spinal induced hypotension and bradycardia in patients undergoing lower limb orthopaedic surgery

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/05/042507
Enrollment
123
Registered
2022-05-12
Start date
Unknown
Completion date
Unknown
Last updated
2022-05-30

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

Conditions

Health Condition 1: M844- Pathological fracture, not elsewhere classified Health Condition 2: M844- Pathological fracture, not elsewhere classified

Interventions

Intervention1: Ondansetron: 4mg(2 ml) iv route 5 minute brfore spinal anaesthesia Control Intervention1: Glycopyrrolate: 0.2 mg( diluted to 2 ml normal saline) IV route 5 minute before spinal anaesthe

Sponsors

Caicutta National Medical College And Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients of age 18-45 years, either sex, ASA physical status I & II undergoing elective lower limb orthopaedic surgeries under spinal anaesthesia will be included in this study.

Exclusion criteria

Exclusion criteria: Exclusion criteria: (i) Patients having contraindications for spinal anaesthesia like lack of consent, raised intra cranial tension, infection at local site, severe aortic stenosis, coagulopathy, cardiovascular instability. (ii) Patients with known allergy to study drugs (iii) Patients with BMI > 30 kg/m² (iv) Patients having height (v) Patients ASA physical status III or more (vi) Patients having major cardiovascular, respiratory, renal, hepatic, metabolic, neurological or endocrine diseases. (vii) Patients with glaucoma (viii) Patients receiving any antihypertensive, vasodilator, antiarrhythmic or antiemetic agents (ix) Patients requiring general anaesthesia

Design outcomes

Primary

MeasureTime frame
incidence of hypotension intraoperatively after giving spinal anaesthesiaTimepoint: 19 months

Secondary

MeasureTime frame
incidence of bradycardia, total phenylephrine requirement and total fluid requirement in the intraoperative period.Timepoint: 19 months

Countries

India

Contacts

Public ContactDr Palas halder

Calcutta National medical college

sudeshna04cmc@yahoo.co.in8777725424

Outcome results

None listed

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