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Comparison of oral midazolam and oral dexmedetomidine as sedation in pediatric patients undergoing elective infra-umbilical surgeries.

Comparison of oral midazolam and oral dexmedetomidine as premedication for sedation in pediatric patients undergoing elective infra-umbilical surgeries: A Double blinded randomized controlled study.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/06/025991
Enrollment
60
Registered
2020-06-19
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

Health Condition 1: K35-K38- Diseases of appendix Health Condition 2: N00-N99- Diseases of the genitourinary system Health Condition 3: K40-K46- Hernia

Interventions

Intervention1: Premedication for sedation in Pediatric patients: Onset of sedation, Ease of parental seperation, Ease of mask acceptance and Emergence delirium Control Intervention1: Midazolam and Dex

Sponsors

S Nijalingappa Medical College and HSK Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients between 1 to 7 years of age, belonging to ASA 1 and 2 (American Society of Anesthesiologists-ASA) 2.Patients posted for elective infra umbilical surgeries.

Exclusion criteria

Exclusion criteria: 1.Refusal of informed consent 2.Mental retardation or neurobehavioral disorders. 3.Under treatment with sedatives or anticonvulsants

Design outcomes

Primary

MeasureTime frame
To assess and compare the onset and peak effect of sedation on administration of oral midazolam and dexmedetomidine as premedication 45 minutes prior to induction of anesthesia.Timepoint: 60 minutes—

Secondary

MeasureTime frame
1.To assess and compare the response at parental separation 2.To determine and compare the quality of mask acceptance 3.To study the emergence delirium in the recovery period 4.To compare the hemodynamic parameters between two groups Timepoint: Duration of the surgery—

Countries

India

Contacts

Public ContactMalladihalli Kiran Ashok Kumar

S Nijalingappa Medical college Navanagar Bagalkot 587102

drchhayajoshi1@gmail.com9743320105

Outcome results

None listed

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