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A study comparing prophylactic intravenous Ondansetron versus Glycopyrrolate to prevent spinal hypotension

A comparative study determining the effect of pre-emptive intravenous Glycopyrrolate versus Ondansetron in preventing spinal hypotension in patients undergoing elective inguinal hernioplasty at a tertiary care hospital - NIL

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/03/083518
Enrollment
110
Registered
2025-03-26
Start date
Unknown
Completion date
Unknown
Last updated
2025-09-15

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

Conditions

Health Condition 1: K409- Unilateral inguinal hernia, without obstruction or gangrene

Interventions

Intervention1: Injection GLYCOPYRROLATE O.2 milligrams Intravenous: Administration of prophylactic intravenous injection GLYCOPYRROLATE (0.2 mg) diluted with sterile water to 0.04mg/cc in a 5 ml clear

Sponsors

Kodagu Institute of medical sciences and teaching hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Elective unilateral inguinal hernioplasty surgeries under spinal anaesthesia 2.American Society of Anaesthesiologists Grade I and Grade II of male/female gender. 3.Patients aged between 18 to 60 years. 4.Patients with BMI less than 30 kg/m2. 5.Patients with height between 155 -170 centimeters

Exclusion criteria

Exclusion criteria: 1. Patients on Beta blockers, Calcium channel blockers, and alpha 2 agonists 2. Gross spinal abnormality. 3. Infection at the site of lumbar puncture. 4. Pre-existing Hemorrhagic diathesis. 5. Pre-existing Neurological disorders. 6. History of allergy to the study drugs

Design outcomes

Primary

MeasureTime frame
To measure the effectiveness of pre emptive intravenous ondansetron and glycopyrrolate in prevention of spinal hypotension by measuring the Mean Arterial Pressure(MAP) to assess the incidence and severity of hypotension after administration of spinal anesthesiaTimepoint: Every 2 min for first 20 min Every 5 min thereafter till end of surgery

Secondary

MeasureTime frame
To determine the total vasopressor requirement after administration of spinal anaesthesiaTimepoint: Number of doses of vasopressor drugs given intraoperatively after the administration of spinal anesthesia till the end of surgery

Countries

India

Contacts

Public ContactDr Aiyappa D S

Kodagu Institute of medical sciences

draiyappads@gmail.com9986336771

Outcome results

None listed

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