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A study on the effect of the drug dexmedetomidine given before surgery on decreasing confusion and agitation in children after general anaesthesia using the gas sevoflurane.

Premedication with single dose of dexmedetomidine for reduction of emergence delirium in paediatric patients with sevoflurane based anaesthesia : a randomized double blind study.

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/07/026323
Enrollment
92
Registered
2020-07-02
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: R418- Other symptoms and signs involvingcognitive functions and awareness

Interventions

Intervention1: Dexmedetomidine hydrochloride: Inj Dexmedetomidine hydrochloride, intravenous, at the dose of 0.5 micro grams per Kilogram of body weight, in 0.9% Sodium chloride, over 10 minutes, prio

Sponsors

Dr Kasturi Mudoi
Lead Sponsor
Dr Faiza Ahmed Talukdar
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Patients belonging to American Society of Anaesthesiologists Grades 1 and 2 and patients scheduled for elective surgeries requiring general anaesthesia

Exclusion criteria

Exclusion criteria: 1. Refusal of consent 2. Intellectual disability 3. Neurological diseases with agitation like symptoms 4. Allergy to dexmedetomidine

Design outcomes

Primary

MeasureTime frame
To compare the incidence of emergence delirium after premedication with single dose of intravenous dexmedetomidine, and placebo.Timepoint: Immediately after extubation, at 5 minutes, 10 minutes, 15 minutes, 30 minutes, 45 minutes, and 60 minutes from the time of extubation.

Secondary

MeasureTime frame
1.To observe the effects on pain, and nausea and vomiting in the immediate post operative period.Timepoint: At 5 minutes, 10 minutes, 15 minutes, 30 minutes, 45 minutes and 60 minutes from the time of extubation.;2.To record other relevant observations, if any.Timepoint: From 5 minutes prior to administration of the drug, till 60 minutes after extubation.

Countries

India

Contacts

Public ContactDr Kasturi Mudoi

Gauhati Medical College and Hospital

faizaahmedtalukdar@gmail.com9864031429

Outcome results

None listed

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