Emergence Agitation after Sevoflurane Anesthesia in Adenotonsillectomy operations: A Placebo-controlled prospective study for evaluation of prophylactic effect of oral premedication

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

PACTR

Registry ID

PACTR202308758655839

Enrollment

220

Registered

2023-08-23

Start date

2023-09-01

Completion date

Unknown

Last updated

2026-01-27

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

Conditions

Anaesthesia

Interventions

placebo Group

midazolam group

dexmedetomedine group

gabapentin group

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1- ASA I & II, 2- aged 3-10 years old children 3-who will be scheduled for adenotonsillectomy operations

Exclusion criteria

Exclusion criteria: 1-ASA II & III 2-any children with congenital anomalies 3- out side the range of current age 4- History of allergy to the medication included in the study 5- Child with cardiac or respiratory diseases

Design outcomes

Primary

Measure	Time frame
The incidence and severity of EA in PACU will be evaluated by the Pediatric Emergence Delirium (PAED) scale consisted of 5-behavoural items, each was scored from 0 to 4 indicating extremely to not at all and the score is the sum of values for the five items	—

Secondary

Measure	Time frame
1- Duration of anaesthesia; defined as duration since induction of anaesthesia till stoppage of inhalational anaesthetic 2- Time till extubation; defined as time since stoppage of inhalational anaesthetic till extubation 3- Time till emergence of anaesthesia; defined as time since extubation till patients’ response by eye opening or purposeful movement in PACU. 4- Level of consciousness after emergence; which will be evaluated using the Ramsay sedation score (RSS) with RSS=1 if patient is anxious and agitated or restless or both; RSS=2 if patient is co-operative, oriented, and calm; RSS=3 if patient is responsive to commands only; RSS=4 if patient is exhibiting brisk response to light glabellar tap or loud auditory stimulus; RSS=5 if patient is exhibiting a sluggish response to light glabellar tap or loud auditory stimulus and RSS=6 if patient is unresponsive. 5- Postoperative pain will be assessed using Children and Infants Postoperative Pain Scale (CHIPPS) score [10] and if CHIPPS pain score was 5, fentanyl 0.5-1 µg/kg will be injected as a rescue medication in PACU with monitoring oxygen saturation using pulse oximetry	—

Measure

Time frame

1- Duration of anaesthesia; defined as duration since induction of anaesthesia till stoppage of inhalational anaesthetic 2- Time till extubation; defined as time since stoppage of inhalational anaesthetic till extubation 3- Time till emergence of anaesthesia; defined as time since extubation till patients’ response by eye opening or purposeful movement in PACU. 4- Level of consciousness after emergence; which will be evaluated using the Ramsay sedation score (RSS) with RSS=1 if patient is anxious and agitated or restless or both; RSS=2 if patient is co-operative, oriented, and calm; RSS=3 if patient is responsive to commands only; RSS=4 if patient is exhibiting brisk response to light glabellar tap or loud auditory stimulus; RSS=5 if patient is exhibiting a sluggish response to light glabellar tap or loud auditory stimulus and RSS=6 if patient is unresponsive. 5- Postoperative pain will be assessed using Children and Infants Postoperative Pain Scale (CHIPPS) score [10] and if CHIPPS pain score was 5, fentanyl 0.5-1 µg/kg will be injected as a rescue medication in PACU with monitoring oxygen saturation using pulse oximetry

—

Countries

Egypt

Contacts

Public ContactAmir Abuzikary

assisstant professor of anesthesia and surgical ICU

aabozikry@yahoo.com01016326544

Outcome results

None listed

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