Compare two different doses of Dexmedetomidine and Ropivacaine on stress response and analgesia on Paediatric hypospadias surgery

Comparision of two different doses of caudal dexmedetomidine as adjuvant to ropivacaine and ropivacaine alone on analgesia and stress response among paediatric patients undergoing hypospadias surgery-a randomised, double blind, controlled, interventional study in SMS medical college, jaipur - nil

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/02/062239

Enrollment

Registered

2024-02-05

Start date

Unknown

Completion date

Unknown

Last updated

2024-03-04

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

Conditions

Health Condition 1: Q549- Hypospadias, unspecified

Interventions

Intervention1: Dexmedetomidine and Ropivacaine: Doses of 1microgram/kg of caudal Dexmedetomidine and 1ml/kg of 0.2% Ropivacaine will be administered to one group while other group receives 1.5 microgr

Eligibility

Inclusion criteria

Inclusion criteria: Children of age group 3-6 years. ASA GRADE I & II Patients for elective urethroplasty surgery

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Mean Cortisol levelTimepoint: Post operative Cortisol levels will be collected 6hrs and 12hrs of surgery	—

Secondary

Measure	Time frame
1. Mean interleukin-6 level. 2. Mean time of first rescue analgesic in post operative Period 3. Mean FLACC Score 4. Mean no of doses of rescue analgesia and mean total dose of rescue analgesia 5. Mean Ramsay sedation score 6. Propotion of cases with side effects 7. Mean Hemodynamic parameters (HR, SPO2,NIBP)Timepoint: Post operative iL-6 levels will be collected 6hrs and 12hrs of surgery Post operative pain assessment (FLACC score)at 2,4,6,8,10 and 12hrs post operatively, time of first rescue analgesia and total dose of analgesia will be noted. Post operatve vitals sedation score and adverse effect at 2,4,6,8,10 and 12hrs will be noted.	—

Measure

Time frame

1. Mean interleukin-6 level. 2. Mean time of first rescue analgesic in post operative Period 3. Mean FLACC Score 4. Mean no of doses of rescue analgesia and mean total dose of rescue analgesia 5. Mean Ramsay sedation score 6. Propotion of cases with side effects 7. Mean Hemodynamic parameters (HR, SPO2,NIBP)Timepoint: Post operative iL-6 levels will be collected 6hrs and 12hrs of surgery Post operative pain assessment (FLACC score)at 2,4,6,8,10 and 12hrs post operatively, time of first rescue analgesia and total dose of analgesia will be noted. Post operatve vitals sedation score and adverse effect at 2,4,6,8,10 and 12hrs will be noted.

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Countries

India

Contacts

Public ContactDr Neelam Dogra

SMS Medical College jaipur

Neelam_dogra24@yahoo.com9928709289

Outcome results

None listed

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