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Comparison of magnesium sulphate versus dexmeditomidine as an adjuvant to ropivacaine for caudal block in paediatric surgeries : a prospective randomized double blind study.

Comparison of analgesic efficacy of magnesium sulphate versus dexmeditomidine as an adjuvant to 0.25% ropivacaine for caudal block in paediatric infraumbilical surgeries : a prospective randomized double blind study.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/08/035876
Enrollment
68
Registered
2021-08-24
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: O- Medical and Surgical

Interventions

Intervention1: Caudal anesthesia: Dexmeditomidine (1 ug/kg) as an adjuvant to 0.25% ropivacaine for caudal block Magnesium sulphate(50mg) as an adjuvant to 0.25% ropivacaine for caudal block Cont

Sponsors

Dr YENDETI AMRUTHA
Lead Sponsor
DR RAJAN ANAND
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: i. Children with informed written consent from their parents. ii. Children posted for infra umbilical surgeries. iii. American Society Anesthesiologists (ASA) physical status Grade I and II. iv. Age between 2 to 10 years of either sex.

Exclusion criteria

Exclusion criteria: i. Anatomical malformation of spine ii. History of neurological and neuromuscular disorders. iii. Coagulation abnormalities iv. Patients with infection at local site. v. Patients with known allergy to local anesthetics. vi. Patient with bloody tap and dural puncture during caudal block

Design outcomes

Primary

MeasureTime frame
Duration of analgesiaTimepoint: Post-operative analgesia will be monitored through The Face, Legs, Activity, Cry, Consolability (FLACC) pain score immediately with recovery, and every 30 min until the 2nd hour, then at the 4th, 6th, 12th,18th, and 24th hours—

Secondary

MeasureTime frame
1. Hemodynamic parameters(Heart rate (HR), Systolic BP(SBP), Diastolic BP(DBP) , Mean Arterial Pressure (MAP), SpO2, Respiratory rate(RR) ) 2. Onset of analgesia 3. Residual motor block 4. Sedation score 5.To study the adverse effects such as nausea, vomiting, bradycardia ,hypotension, respiratory depression Timepoint: Hemodynamic parameters will be monitored at 0, 15 and 30 min following caudal block, and at the end of surgery and Postoperatively every 30 min for first two hours, at 4,6,12,18 and 24th hour. Post-operative analgesia, sedation and Residual motor blockade will be monitored immediately with recovery, and the 1st, 2nd, 3rd, 4th, 6th, 8th, 12th, 18th, and 24th hours postoperatively. Adverse effects monitored and managed for 24 hrs.—

Countries

India

Contacts

Public ContactDR YENDETI AMRUTHA

Sri Satya Sai Institute of Higher Medical Sciences Prasantigram

rajan.a@sssihms.org.in9440699330

Outcome results

None listed

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