FindTrial
Sign In

Intranasal Dexmed vs Intranasal Midazolam via Mucosal atomiser for Emergence Agitation

Intranasal dexmedetomidine versus intranasal midazolam via mucosal atomization device in Prevention of emergence agitation in pediatric cataract surgery under sevoflurane anaesthesia- A Randomised Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/03/023752
Enrollment
100
Registered
2020-03-04
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: Q120- Congenital cataract

Interventions

Intervention1: Dexmedetomidine: Dose - 2 microgram per kg Route- Intranasal Mode- Via Mucosal Atomiser Frequency- only once, 30 mins before surgery Control Intervention1: Midazolam: Dose - 0.2 milligr

Sponsors

DIRECTOR PGIMER CHANDIGARH
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: ASA 1 and ASA 2 patients undergoing cataract surgery

Exclusion criteria

Exclusion criteria: 1 ORGAN DYSFUCNTION 2 CARDIAC ARRYTHMIAS OR CONGENTIAL DISEASE 3 DEVELEOPMENTAL DELAY 4 NEUROLOGICAL DISEASES 5 ANY ACTIVE URTI 6 CHILDREN AT RISK OF UPPER AIRWAY OBSTRUCTION 7 KNOWN ALLERGY TO DEXMEDTOMIDINE OR MIDAZOLAM

Design outcomes

Primary

MeasureTime frame
Incidence Of Emergence AgitationTimepoint: @ 0 minute, 5 minute, 10 minute , 15 minute , 20 minute, 25 minute, 30 minutes. upto 6 hours post op—

Secondary

MeasureTime frame
Face Mask AcceptanceTimepoint: At time of induction of anaesthesia;Parent/Guardian SatisfactionTimepoint: 6 hours after surgery;Postoperative PainTimepoint: 0 MIN, 5 MIN, 10MIN, 15 MIN, 20 MIN, 25 MIN , 30 MIN, Till 6 hours post surgery;Pre-procedural SedationTimepoint: 0 mins before surgery;Preoperative AnxietyTimepoint: 30 Mins, 20 Mins, 10 Mins, 0 Mins Before surgery—

Countries

India

Contacts

Public ContactBalsher Kular

PGIMER

balshersinghkular.bsk@gmail.com9915670019

Outcome results

None listed

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