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To study the genetic influences for variations in effectiveness of Ondansetron to prevent nausea and vomiting

Investigation of influence of 5HT3B gene, ABCB1 gene and cytochromeP450 2D6 gene polymorphism in efficacy of antiemetic treatment with Ondansetron in post-operative south Indian female patients. A prospective observational study.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2019/04/018447
Enrollment
160
Registered
2019-04-08
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: H741- Adhesive middle ear disease Health Condition 2: K801- Calculus of gallbladder with othercholecystitis Health Condition 3: N719- Inflammatory disease of uterus, unspecified Health Condition 4: C501- Malignant neoplasm of central portion of breast

Interventions

Intervention1: Clinical efficacy of Ondansetron for the management of PONV: Ondansetron will be given at a dose of 0.1mg/kg intra venously intra operatively. Assessment of PONV will be done at 0-6 h

Sponsors

Rajiv Gandhi University of Health Sciences Bangalore
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. South Indian female population of age group between 20-60 years of age All cases of Breast surgeries, Laproscopic hysterectomy and cholecystectomy surgeries and Mastoidectomy, administered with only Ondansetron intra operatively

Exclusion criteria

Exclusion criteria: 1. Very seriously ill patients who do not have somebody to accompany them because of the difficulty of interviewing such cases (getting the consent, lack tolerance of the pain or illness). 2. Patient refusal. 3. Patients who are on Cytochrome P450 inducers (eg, Rifampcin, Phenobarbitone, Phenytoin etc) or inhibitors ( eg, Quinidine, Fluoxetine, Haloperidol etc) 4. Cognitive dysfunction or any other inability to finish the interview. 5. Patients with concomitant diseases that might cause nausea or vomiting (eg, severe heart failure, ulcerations or obstructions of the upper gastrointestinal system, severe hepatic or renal dysfunction, and brain metastases). 6. Patients with prolonged QT interval 7. Patients with motion sickness 8. Pregnant patients.

Design outcomes

Primary

MeasureTime frame
Information about the influence of genetic polymorphism in 5-HT3B gene, ABCB1 gene and cytochrome P450 2D6 gene in the efficacy of ondansetron therapy in post-operative south Indian female patients.Timepoint: After one month of recruitment of the patient—

Secondary

MeasureTime frame
Knowledge about clinical efficacy of Ondansetron using Nausea and Emesis Scale.Timepoint: .Assessment of nausea and vomiting using Nausea and Emesis Scale from recovery room till 48 hrs (0-6 hr, 6-12hr, 12-24 hrs and 24-48hr)—

Countries

India

Contacts

Public ContactDr Reena R Kadni

Bangalore Baptist Hospital.

kusususan@gmail.com9620128113

Outcome results

None listed

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