Comparison of two doses of a medication which decreases the occurrence of agitation after surgery in children undergoing throat surgery with or without ear surgery.

Comparison of two doses of Dexmedetomidine for the reduction of emergence delirium in children undergoing tonsillectomy/ adenotonsillectomy with or without myringotomy: A Randomized Controlled Trail. - nil

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/02/079870

Enrollment

120

Registered

2025-02-03

Start date

Unknown

Completion date

Unknown

Last updated

2025-03-03

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Dexmedetomidine 0.4mcg/kg iv: Dexmedetomidine 0.4mcg/kg iv single bolus over 10minutes after intubation before the insertion of mouth gag. Control Intervention1: Dexmedetomidine 1mcg/kg

Eligibility

Inclusion criteria

Inclusion criteria: ASA 1,2 children between the ages of 2 to 12 years scheduled for tonsillectomy/ adenotonsillectomy with or without myringotomy will be enrolled in the study.

Exclusion criteria

Exclusion criteria: Children with a known history of allergy to the study drug, neurological, neuromuscular, renal or hepatic diseases, craniofacial abnormalities and cardiac diseases will be excluded. All patients scheduled for DISE (Drug Induced Sleep Endoscopy) will also be excluded.

Design outcomes

Primary

Measure	Time frame
To compare two doses of Dexmedetomidine for the reduction of emergence delirium in children undergoing tonsillectomy/adenotonsillectomy with or without myringotomy.Timepoint: In Post Anaesthesia Care Unit(PACU), the Watcha- scale (Asleep-0, calm-1, crying but can be controlled-2, crying but cannot be controlled-3, agitated and thrashing-4) will be used to record emergence agitation by a blinded anaesthetist every 10 minutes for the first 30 minutes and every 15 minutes for the next 30 minutes after endotracheal tube was removed. watcha scale score will be recorded at 10minutes 20 minutes, 30 minutes, 45minutes and 60minutes in PACU.	—

Measure

Time frame

To compare two doses of Dexmedetomidine for the reduction of emergence delirium in children undergoing tonsillectomy/adenotonsillectomy with or without myringotomy.Timepoint: In Post Anaesthesia Care Unit(PACU), the Watcha- scale (Asleep-0, calm-1, crying but can be controlled-2, crying but cannot be controlled-3, agitated and thrashing-4) will be used to record emergence agitation by a blinded anaesthetist every 10 minutes for the first 30 minutes and every 15 minutes for the next 30 minutes after endotracheal tube was removed. watcha scale score will be recorded at 10minutes 20 minutes, 30 minutes, 45minutes and 60minutes in PACU.

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Secondary

Measure	Time frame
To find out the time to wake up, need for rescue analgesic, if needed its dose, the incidence of PONV & duration of stay in the PACU.Timepoint: Ramsay Agitation Sedation Scale RASS score assessed at 10,20,30,45,60minutes after endotracheal tube was removed. Fentanyl 1 mcg/kg iv will be given as rescue medication & time at which the first dose given will be noted if the watcha score is more than or equal 2 during 1hr in PACU. The wake-up time extubation to time to eye open & prevalence of PONV at 10,20,30,45,60minutes & duration of stay in PACU will also be recorded once the patient is discharged from PACU.	—

Measure

Time frame

To find out the time to wake up, need for rescue analgesic, if needed its dose, the incidence of PONV & duration of stay in the PACU.Timepoint: Ramsay Agitation Sedation Scale RASS score assessed at 10,20,30,45,60minutes after endotracheal tube was removed. Fentanyl 1 mcg/kg iv will be given as rescue medication & time at which the first dose given will be noted if the watcha score is more than or equal 2 during 1hr in PACU. The wake-up time extubation to time to eye open & prevalence of PONV at 10,20,30,45,60minutes & duration of stay in PACU will also be recorded once the patient is discharged from PACU.

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Countries

India

Contacts

Public ContactDr Abishma A M

Christian Medical College, Vellore.

williamsaparna@gmail.com8098899339

Outcome results

None listed

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