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ComparingVitamin B6 Plus Ondanetron Versus Ondansetron Alone to Prevent Nausea and Vomiting In Laproscopic Surgery: A Doulbe-Blind Study

Comparison of Pyridoxine-Ondansetron Versus Ondansetron alone for post Operative Nausea Vomiting Prophylaxis in Laprroscopic Surgery: A Randomised Double Blind Trial - Nil

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/09/095416
Enrollment
90
Registered
2025-09-26
Start date
Unknown
Completion date
Unknown
Last updated
2025-10-13

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: Antiemetic will be given preoperatively: 1 h before surgery Control Intervention1: Oral pyridoxine tablet: 1 h prior to surgery in group PO Control Intervention2: Group NO: No drug will

Sponsors

UCMS and GTB Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Consenting ASAI/II adult females Undergoing laparoscopic surgery Requiring general anesthesia

Exclusion criteria

Exclusion criteria: Pregnant patient, Patient with cardiac, hepatic and renal disease and known case of tuberculosis Developmental delay, mental illness, severe neurological disease Allergic to any drug used in study Long term use of long-acting antiemetic, emetogenic drugs, opoids, glucocorticoids or cancer therapy and add on any antiemetic in last 24 hours

Design outcomes

Primary

MeasureTime frame
Incidence of post operative nausea vomiting(PONV) in first 24 hour after surgeryTimepoint: Postoperative- 0-2 hour, 2-6 hour, 6-12 hour, 12-24 hour

Secondary

MeasureTime frame
Time to first occurrence of PONV Severity of PONV Requirement of rescue antiemetic drugs Side effects, if anyTimepoint: Intraoperative- 15 min, 30 min, 60min, 90 min, 120 min, 150 min, 180 min, 210 min Postoperative- 0-2 hour, 2-6 hour, 6-12 hour, 12-24hour

Countries

India

Contacts

Public ContactDr Sakshi

University College of Medical Sciences and GTB Hospital, Delhi

rsalhotra@ucms.ac.in9911317334

Outcome results

None listed

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