Skip to content

comparison of 2 drugs for prevention of agitation in children after waking up from anaesthesia

PREVENTION OF "EMERGENCE AGITATION" WITH PROPOFOL OR FENTANYL IN CHILDREN UNDERGOING BELOW UMBILICAL SURGERIES UNDER SEVOFLURANE ANAESTHESIA

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/04/013246
Enrollment
100
Registered
2018-04-13
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- for any surgery under general anaesthesia

Interventions

Intervention1: Fentanyl: 1ug/kg IV Control Intervention1: Propofol: 1mg/kg IV

Sponsors

Department of Anaesthesiology
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: ASA grade I&II in age group 3-7 yrs of both sexes scheduled for elective surgery under Sevoflurane Anaesthesia.

Exclusion criteria

Exclusion criteria: 1. Anticipated Difficult airway 2. Emergency surgical procedure 3. Developmental delay 4. Psychological or neurological disorders 5. Patients with any systemic disease 6. Refusal by the patient 7. H/O allergy to any drug

Design outcomes

Primary

MeasureTime frame
The degree of Emergence agitation EA in postoperative period measured every 5 min till 30 minutes using two (2) scales i.e. PAED scale and AONO scaleTimepoint: Every 5 min till 30 min

Secondary

MeasureTime frame
1. Hemodynamic parameters measured â?? Heart rate, NIBP 2. ECG, SpO2, EtCO2, RR will be continuously monitored. 3. Time of administeration of test drug. 4. Time of removal of LMA. 5. Time of recovery of consciousness. 6. Time of full awakening. 7. All adverse effects like excessive sedation, nausea, vomiting, respiratory depression, hypotension or bradycardia will be noted in postoperative period 8. Any rescue medication given will also be noted. Timepoint: 0 min, every 5 minutes till the end of surgery

Countries

India

Contacts

Public ContactSunil Sinha

Lady Hardinge Medical College

sunilsinha248@gmail.com9868493597

Outcome results

None listed

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