To study the genetic influences for variations in effectiveness of Ondansetron to prevent nausea and vomiting
- Conditions
- Health Condition 1: H741- Adhesive middle ear diseaseHealth Condition 2: K801- Calculus of gallbladder with othercholecystitisHealth Condition 3: N719- Inflammatory disease of uterus, unspecifiedHealth Condition 4: C501- Malignant neoplasm of central portion of breast
- Registration Number
- CTRI/2019/04/018447
- Lead Sponsor
- Rajiv Gandhi University of Health Sciences Bangalore
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
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
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.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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)