Role of vitamin B6 in reducing nausea and vomiting in patients undergoing laparoscopic abdominal surgeries.

Efficacy of preoperative oral pyridoxine in preventing postoperative nausea and vomiting in patients undergoing laparoscopic abdominal surgeries - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/07/091514

Enrollment

280

Registered

2025-07-23

Start date

Unknown

Completion date

Unknown

Last updated

2025-08-18

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: Pyridoxine (Vitamin B6): All patients will follow standard ASA fasting guidelines (8 hours for solids, 2 hours for clear fluids) and receive oral alprazolam 0.25 mg the night before sur

Eligibility

Inclusion criteria

Inclusion criteria: 1.Adults aged between 18 80 years. 2.ASA physical status I III. 3.Scheduled for laparoscopic cholecystectomy or laparoscopic inguinal hernia repair. 4.Patients who have given informed consent.

Exclusion criteria

Exclusion criteria: 1.Known allergy to study drugs. 2.Chronic use of antiemetics, corticosteroids, or opioids. 3.Pregnancy or lactation. 4.History of gastrointestinal disorders (e.g., hepatitis, gastric ulcers). 5.Acute cholecystitis.

Design outcomes

Primary

Measure	Time frame
To compare the incidence of postoperative nausea, vomiting and retching up to 24 hours after laparoscopic surgery between patients receiving a combination of pyridoxine, ondansetron, and dexamethasone versus those receiving ondansetron and dexamethasone alone.Timepoint: First 24 hours of the postoperative period at predefined fixed time intervals.	—

Secondary

Measure	Time frame
To compare the severity of postoperative nausea and vomiting in both the groups.Timepoint: First 24 hours of the postoperative period at predefined fixed time intervals .;To compare the use of rescue antiemetics up to 24 hours in both the groups.Timepoint: First 24 hours of the postoperative period at predefined fixed time intervals.;To monitor for any drug-related adverse events in the group receiving pyridoxine.Timepoint: First 24 hours of the postoperative period at predefined fixed time intervals.;To compare the patient-reported satisfaction scores with respect to peri-operative management of postoperative nausea and vomiting in both the groups.Timepoint: First 24 hours of the postoperative period at predefined fixed time intervals.	—

Measure

Time frame

To compare the severity of postoperative nausea and vomiting in both the groups.Timepoint: First 24 hours of the postoperative period at predefined fixed time intervals .;To compare the use of rescue antiemetics up to 24 hours in both the groups.Timepoint: First 24 hours of the postoperative period at predefined fixed time intervals.;To monitor for any drug-related adverse events in the group receiving pyridoxine.Timepoint: First 24 hours of the postoperative period at predefined fixed time intervals.;To compare the patient-reported satisfaction scores with respect to peri-operative management of postoperative nausea and vomiting in both the groups.Timepoint: First 24 hours of the postoperative period at predefined fixed time intervals.

—

Countries

India

Contacts

Public ContactDr Sanjeev Palta

Government Medical College and Hospital, Chandigarh

richajayant@rediffmail.com9646121513

Outcome results

None listed

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