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A single dose of propofol at the end of surgery for prevention of emergence agitation in children receiving sevoflurane anesthesia for cleft palate surgery

A single dose of propofol at the end of surgery for prevention of emergence agitation in children receiving sevoflurane anesthesia for cleft palate surgery.

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20250506004
Enrollment
52
Registered
2025-05-06
Start date
2025-05-13
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Emergence agitation (EA) is a common postoperative complication after sevoflurane anesthesia, which may lead to wound dehiscence and pulmonary complications that might result in delayed recovery and a prolonged hospital stay. EA is defined as psychomotor agitation and delirium that typically occurs within 45 min from emergence of anesthesia. In cleft palate surgery, incidence of emergence agitation in children receiving sevoflurane anesthesia is high (76-85%). Emergence agitation, cleft palate,

Interventions

Group propofol will receive propofol 1 mg/kg at the end of operation.,Group saline will receive normal saline with equivalent volume to propofol group at the end of operation.
Active Comparator Drug,No Intervention No treatment
Propofol group,Saline group

Sponsors

Research Affairs, Faculty of Medicine, KKU
Lead Sponsor

Eligibility

Sex/Gender
All
Age
8 Months to 6 Years

Inclusion criteria

Inclusion criteria: 1. ASA classification 1-2, 2. Scheduled for elective palatoplasty and/or other surgeries, such as cheiloplasty, myringotomy, etc., under general anesthesia.

Exclusion criteria

Exclusion criteria: 1. Parent refusal, 2. History of allergy to propofol, egg and other drugs in the study, 3. Neurological disorder or psychological disorder

Design outcomes

Primary

MeasureTime frame
Emergence agitation On arrival at PACU and then every 15 minutes until 60 minutes Pediatric Anesthesia Emergence Delirium score

Secondary

MeasureTime frame
Severity of emergence agitation On arrival at PACU and then every 15 minutes until 60 minutes Pediatric Anesthesia Emergence Delirium score,Postoperative pain On arrival at PACU and then every 15 minutes until 60 minutes Face, Legs, Activity, Cry, Consolability score,Postoperative nausea and vomiting (PONV) at PACU The events of nausea and vomiting,Incidence of hypotension every 2 minutes after intervention given until 10 min then every 15 minutes Blood pressure,Incidence of bradycardia every 2 minutes after intervention given until 10 min then every 15 minutes Heart rate,Incidence of oxygen desaturation every 2 minutes after intervention given until 10 min then every 15 minutes Oxygen saturation,Time of extubation From discontinuing sevoflurane to extubation Time,PACU discharge time From PACU arrival to PACU discharge Time,Parents' satisfaction Before discharge from PACU Numerical rating scale from 1-5

Countries

Thailand

Contacts

Public ContactPrathana Wittayapairoch

Srinagarind hospital

prathana@kku.ac.th0896222682

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026