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A clinical trial to compare the effects of two drug combinations, ropivacaine plus dexmedetomidine versus bupivacaine plus dexmedetomidine in caudal block in children.

A comparative study of ropivacaine versus bupivacaine with dexmedetomidine as an adjuvant in paediatric caudal block.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/09/021183
Enrollment
100
Registered
2019-09-11
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: null- American Society of Anaesthesiologists (ASA) grade I and II, aged between 2 yrs and 7 yrs undergoing infraumbilical surgeries. Health Condition 2: K409- Unilateral inguinal hernia, without obstruction or gangrene Health Condition 3: K409- Unilateral inguinal hernia, without obstruction or gangrene

Interventions

Intervention1: Caudal epidural block with ropivacaine and dexmedetomidine: Patient will be given adequate geneal anaesthesia. Caudal block will be given with 1 ml/kg of 0.25% ropivacaine and dexmedeto

Sponsors

VARDHMAN MAHAVIR MEDICAL COLLEGE AND SAFDARJUNG HOSPITAL
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients of American Society of Anaesthesiologists (ASA) grade I and II, aged between 2 yrs and 7 yrs undergoing infraumbilical surgeries.

Exclusion criteria

Exclusion criteria: 1.Patients having hypersensitivity to ropivacaine,bupivacaine or dexmedetomidine. 2.Local site infection, coagulopathies, fever or abdominal injuries. 3.Patients with pre-existing neurological diseases, spinal abnormalities or developmental delay.

Design outcomes

Primary

MeasureTime frame
To compare and evaluate the duration of post-operative analgesia of 0.25% ropivacaine and dexmedetomidine with 0.25% bupivacaine and dexmedetomidine using FLACC scale in paediatric caudal block.Timepoint: post-operatively.—

Secondary

MeasureTime frame
1. To compare the duration of sedation using Ramsay Sedation Score. 2. Evaluation and comparison of motor block characteristics using Bromage Scale. 3.To evaluate any haemodynamic variability like bradycardia, tachycardia, hypotension or hypertension. 4. To evaluate any other side effects like respiratory depression, nausea, vomitting and involuntary movemets. Timepoint: intra-operatively and post-operatively.—

Countries

India

Contacts

Public ContactDR AKASH KUMAR TRIPATHI

VARDHMAN MAHAVIR MEDICAL COLLEGE AND SAFDARJUNG HOSPITAL

p.gupta182@gmail.com9818623450

Outcome results

None listed

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