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

Phase 3

Completed

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.

Registration Number: CTRI/2014/06/004694

Lead Sponsor: PGIMER Chandigarh

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 40

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:

.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)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures