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We will compare the efficacy of the three drugs dexmedetodomidine ,ketofol and saline after orofacial cleft surgery in children with regard to reduction of agitation.

Comparison of the effect of dexmedetomidine,ketofol and saline on postoperative emergence delirium in paediatric patients undergoing orofacial cleft surgery:A randomised control trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/06/034077
Enrollment
105
Registered
2021-06-08
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: Q189- Congenital malformation of face and neck, unspecified Health Condition 2: Q379- Unspecified cleft palate with unilateral cleft lip

Interventions

Intervention1: iv dexmedetomidine (0.3 mcg/kg diluted in normal saline to a volume of 10 ml),10 min before the end of surgery: Group A: will receive Iv dexmedetomidine (0.3 mcg/kg diluted in normal

Sponsors

Department of anaesthesiology AIIMS PATNA
Lead Sponsor
Department of anaesthesiology AIIMS PATNA
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Both sexes(female and male) ASA physical status grade I and II Age between 3 months to 2 years Scheduled for oro-facial cleft surgery

Exclusion criteria

Exclusion criteria: • lack of consent • ASA >2 • cardiovascular disease • difficult intubation( >3 attempts or >10 min endotracheal tube insertion time) • Patient on anticonvulsant medication

Design outcomes

Secondary

MeasureTime frame
Postoperative AnalgesiaTimepoint: AT 0 min, 10min, 20min, 30min and 60 min POST OPERATIVELY—

Primary

MeasureTime frame
INCIDENCE OF EMERGENCE DELIRIUM USING WATCHA SCORETimepoint: AT 0min, 5min,10min, 20min, 30min and 60 min POST OPERATIVELY—

Countries

India

Contacts

Public ContactDr Surbhi

Aiims patna

drpoonam1981@gmail.com7992418198

Outcome results

None listed

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