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Effect of a drug named Dexmedetomidine on delirium in children in Cataract Surgeries after Anaesthesia

Effect of Dexmedetomidine on Emergence Agitation in Paediatric Cataract Surgeries Under Desflurane Anaesthesia

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2014/06/004694
Enrollment
40
Registered
2014-06-23
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- Forty children, aged 2-10 years, otherwise healthy with no other diseases admitted under the Department of Ophthalmology, PGIMER will be enrolled for the study after appropriate evaluation.

Interventions

Intervention1: Dexmeditomidine drug: 2 different doses of dexmeditomidine i.e.0.15 microgm/Kg and 0.30 microgram/kg Intervention2: Dexmeditomidine drug: 2 different doses of dexmeditomidine Interventi

Sponsors

PGIMER Chandigarh
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: . Forty children, aged 2-10 years, belonging to American Society of Anaesthesiologists (ASA) I - II admitted under the Department of Ophthalmology, PGIMER will be enrolled for the study after appropriate evaluation.

Exclusion criteria

Exclusion criteria: Exclusion Criteria: .Lack of consent •Known adverse effects to dexmedetomidine •History of seizures or mental retardation •Developmental delay, or neurological or psychiatric illness that may associate with agitation (cerebral palsy, seizure, etc) • Known endocrine disease • A family history of malignant hyperthermia • Emergency procedure • Attention deficit hyperkinetic disorder • Psychiatric illness • History of paradoxical excitation with sedatives • History of previous episode of emergence delirium • preoperative EKG abnormality e.g. cardiovascular conduction disorder • Recent upper respiratory tract infections.(URTI). • Bleeding disorders / coagulation abnormalities. • Associated anomalies demanding deviation from standard anaesthetic protocol(Airway abnormalities precluding use of Laryngeal Mask Airway, tumor or infection of the orbit, compromised sclera, single eye vision, raised IOP)

Design outcomes

Primary

MeasureTime frame
To evaluate the effectiveness and safety of IV Dexmedetomidine (i.e. 0.15 µg/kg and 0.3µg/kg) for preventing desflurane induced emergence agitation in children undergoing cataract surgery under subtenon block.Timepoint: Different time intervals in Postoperative period

Secondary

MeasureTime frame
To evaluate the recovery profile with these two doses.Timepoint: Different time intervals in Postoperative period

Countries

India

Contacts

Public ContactDr Sameer Sethi

Post Graduate Institute of Medical Education and Research(PGIMER)

itzshikhahere@gmail.com

Outcome results

None listed

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