Compare two different doses of Dexmedetomidine and Ropivacaine on stress response and analgesia on Paediatric hypospadias surgery
Phase 4
- Conditions
- Health Condition 1: Q549- Hypospadias, unspecified
- Registration Number
- CTRI/2024/02/062239
- Lead Sponsor
- SMS medical college jaipur
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Children of age group 3-6 years.
ASA GRADE I & II
Patients for elective urethroplasty surgery
Exclusion Criteria
Lack of consent by parents or guardian
Children with congenital heart disease, respiratory compromise or obstructive sleep apnea, renal, hepatic orneurological condition
genetic and metabolic conditions
Children with known allergy to the study drugs
5) Contraindications to caudal anaesthesia such as raised ICT, infection at the injection site, space occupying lesions of brain and hypovolemia.
6) History of spinal surgery or sacral canal closure.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean Cortisol levelTimepoint: Post operative Cortisol levels will be collected 6hrs and 12hrs of surgery
- Secondary Outcome Measures
Name Time Method 1. Mean interleukin-6 level. <br/ ><br>2. Mean time of first rescue analgesic in post operative Period <br/ ><br>3. Mean FLACC Score <br/ ><br>4. Mean no of doses of rescue analgesia and mean total dose of rescue <br/ ><br>analgesia <br/ ><br>5. Mean Ramsay sedation score <br/ ><br>6. Propotion of cases with side effects <br/ ><br>7. Mean Hemodynamic parameters (HR, SPO2,NIBP)Timepoint: Post operative iL-6 levels will be collected 6hrs and 12hrs of surgery <br/ ><br>Post operative pain assessment (FLACC score)at 2,4,6,8,10 and 12hrs post operatively, <br/ ><br>time of first rescue analgesia and total dose of analgesia will be noted. <br/ ><br>Post operatve vitals sedation score and adverse effect at 2,4,6,8,10 and 12hrs <br/ ><br>will be noted. <br/ ><br>