A study comparing Vitamin B6 and Pregabalin given 2 hours before keyhole means Laparoscopic abdominal surgery to prevent nausea and vomiting during the first 24 hours after surgery.

Efficacy of preoperative oral pyridoxine verses pregabalin for the prevention of postoperative nausea and vomiting in laparoscopic abdominal surgeries. - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/07/113960

Enrollment

150

Registered

2026-07-14

Start date

Unknown

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

Health Condition 1: K802- Calculus of gallbladder without cholecystitis

Interventions

Intervention1: Oral Pyridoxine 200 mg: The Group P (Pyridoxine Group), will receive oral pyridoxine 200mg in the morning two hours before surgery, dexamethasone 8 mg at induction and 4 mg ondansetron

Eligibility

Inclusion criteria

Inclusion criteria: Adults aged 18 to 80 years ASA physical status I to III Scheduled for laparoscopic abdominal surgeries

Exclusion criteria

Exclusion criteria: Known allergy to study drugs Chronic use of antiemetics, corticosteroids, or opioids Pregnancy or lactation History of gastrointestinal disorders like hepatitis, gastric ulcers etc Acute cholecystitis

Design outcomes

Primary

Measure	Time frame
To compare the incidence of postoperative nausea and vomiting up to 24 hours after laparoscopic surgery between patients receiving a combination of pyridoxine, ondansetron, and dexamethasone versus those receiving pregabalin, ondansetron, and dexamethasone. Timepoint: 4 readings immediately after extubation that is 0 hour, followed by 6 hours, 12 hours and 24 hours	—

Secondary

Measure	Time frame
To study the incidence of nausea, vomiting/retching separately, up to 24 hours in both groups. To compare the use of rescue antiemetics up to 24 hours in both groups. To note for any drug-related adverse events with pyridoxine or Pregabalin. To compare the patient-reported Quality of Recovery 15 Questionnaire score between both groups. To compare the postoperative pain via the visual Analog scale in both groups.Timepoint: 4 readings immediately after extubation that is 0 hours, followed by 6 hours, 12 hours and 24 hours	—

Measure

Time frame

To study the incidence of nausea, vomiting/retching separately, up to 24 hours in both groups. To compare the use of rescue antiemetics up to 24 hours in both groups. To note for any drug-related adverse events with pyridoxine or Pregabalin. To compare the patient-reported Quality of Recovery 15 Questionnaire score between both groups. To compare the postoperative pain via the visual Analog scale in both groups.Timepoint: 4 readings immediately after extubation that is 0 hours, followed by 6 hours, 12 hours and 24 hours

—

Countries

India

Contacts

Public ContactDr Sanjeev Palta

Government Medical College and Hospital, Chandigarh

richajayant@rediffmail.com09646121513

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Aug 10, 2026