Clinical study to evaluate the efficacy of Tapentadol nasal spray in patients undergoing below umbilical surgery under Spinal Anesthesia.
- Conditions
- Health Condition 1: - Health Condition 2: N838- Other noninflammatory disorders ofovary, fallopian tube and broad ligamentHealth Condition 3: R398- Other symptoms and signs involvingthe genitourinary system
- Registration Number
- CTRI/2024/03/064850
- Lead Sponsor
- Bangalore Medical College and Research Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. Patients who have given written informed consent.
2. Patients aged 18-60 years.
3. Sex- males and females.
4. Patients scheduled for elective infraumblical surgery under spinal
anesthesia.
5. Patients with ASA grade I & II.
1. Patients not willing to give consent and refusing to participate in the study.
2. Patients with any contraindications for neuraxial blockade.
3. Known allergy to any of the study medication.
4. Patient on Opioid dependence.
5. Patients who have taken any medication by intranasal route within the past 72
hours prior to randomization.
6. Patients with severe bronchial asthma, paralytic ileus, nasal allergy, upper
respiratory tract infection.
7. Patients with current history of psychiatric illness and being treated with
tricyclic antidepressants, selective serotonin reuptake inhibitors, selective
noradrenaline reuptake inhibitors, anticonvulsants, neuroleptics, triptans,
monoamine oxidase inhibitors, steroids , a-2 agonists or opioid medications
within 28 days before scheduled surgery.
8. Patient with any end organ dysfunction.
9. Pregnancy.
10. Patient with history of alcohol abuse, smoking habit, drug abuse.
11. Uncontrolled cases of diabetes mellitus, hypertension, ischemic heart disease,
arrhythmias.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method