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Study to compare the efficacy of intravenous phenylephrine infusion versus intravenous Ramosetron in the prevention of hypotension post spinal anaesthesia for patients undergoing elective surgery for inguinal hernia i.e. herniorhhaphy/hernioplasty

Study on comparison of prophylactic phenylephrine infusion versus intravenous ramosetron on hypotension during spinal anaesthesia for herniorhhaphy , hernioplasty : A Randomized controlled trial - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/09/073332
Enrollment
84
Registered
2024-09-04
Start date
Unknown
Completion date
Unknown
Last updated
2024-09-16

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

Conditions

Health Condition 1: K40-K46- Hernia Health Condition 2: O- Medical and Surgical

Interventions

Intervention1: Phenylephrine: In patients receiving prophylactic phenylephrine infusion i.v. infusion of phenylephrine(25 µg.min-1 ) will be started post puncture and continued for 30 minutes post spi

Sponsors

RAJENDRA INSTITUTE OF MEDICAL SCIENCES
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Adult patient ASA status type I or II. Patient of inguinal hernia undergoing Elective Surgery requiring spinal anaesthesia. Patient height between 160 c.m. – 170 c.m.

Exclusion criteria

Exclusion criteria: Patient having known allergy to any of medication to be used in the study(phenylephrine and ramosetron). Emergency cases. Patient having other comorbidities. ASA status type 3 and 4.

Design outcomes

Primary

MeasureTime frame
To compare the efficacy of intravenous phenylephrine infusion(25 µg.min-1) versus intravenous Ramosetron(0.3mg) versus 0.9% Normal saline (placebo) infusion in the prevention of hypotension post spinal anaesthesia for patients undergoing elective surgery for inguinal hernia i.e. herniorhhaphy/hernioplasty. Mean Arterial pressure , systolic and diastolic blood pressure and Heart rate will bw measured.Timepoint: pre induction post spinal puncture At every 2 minutes interval for first 15 minutes Then at every 5 minutes for next 15 minutes Then at every 10 minutes interval for rest of duration of surgery.

Secondary

MeasureTime frame
To compare the incidence of episodes of nausea and vomiting between three groups. Timepoint: post spinal puncture till end of surgery.;To compare the incidence of episodes of skin flushing and other patient discomfort between three groups. Timepoint: post spinal puncture till end of surgery

Countries

India

Contacts

Public ContactDR BHARATI

RAJENDRA INSTITUTE OF MEDICAL SCIENCES

dipalishio@gmail.com9620310511

Outcome results

None listed

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