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In Geriatric Patients prevention of Spinal Anaesthesia-Induced Hypotension using IM Glycopyrrolate Versus Placebo

To compare the role of prophylactic intramuscular glycopyrrolate versus placebo in reducing spinal anaesthesia induced hypotension in geriatric population - Nil

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/12/098883
Enrollment
60
Registered
2025-12-11
Start date
Unknown
Completion date
Unknown
Last updated
2026-01-12

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: spinal anesthesia: A standardized technique for spinal anaesthesia will be employed for all patients.Group A ( Glycopyrrolate group): will receive 0.2 mg (1 mL) glycopyrrolate intramusc

Sponsors

SGRD
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: ASA grade I to III patients.

Exclusion criteria

Exclusion criteria: 1.Infection at puncture site 2.Allergy to anaesthetic drug 3.Elevated intracranial pressure 4.Coagulation disorders

Design outcomes

Primary

MeasureTime frame
Incidence of spinal induced hypotensionTimepoint: Continuous intraoperative monitoring of vital signs including heart rate, blood pressure, oxygen saturation (SpO2), and respiratory rate will be documented at 2-minute intervals for initial 10 minutes, followed by 5-minute intervals until completion of surgery. Postoperative monitoring will continue in the post-anesthetic care unit (PACU) at 15-minute intervals, and subsequently in the ward for 4,8,12 & 24 hours postoperatively

Secondary

MeasureTime frame
1.Requirement of ephedrine(MAP less than 20 percent decrease from baseline) 2.Incidence of bradycardia (HR less than 60 bpm or 20 percent decrease from baseline) 3.Incidence of nausea and vomitingTimepoint: Continuous intraoperative monitoring of vital signs including heart rate, blood pressure, oxygen saturation (SpO2), and respiratory rate will be documented at 2-minute intervals for initial 10 minutes, followed by 5-minute intervals until completion of surgery. Postoperative monitoring will continue in the post-anesthetic care unit (PACU) at 15-minute intervals, and subsequently in the ward for 4,8,12 & 24 hours postoperatively

Countries

India

Contacts

Public ContactDr Amritpal Singh

Sri Guru Ram Das Institute of Medical Sciences and Research

sgrdanaesthesia@gmail.com9815632909

Outcome results

None listed

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