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Clinical Trials/CTRI/2025/02/079870
CTRI/2025/02/079870
Recruiting
Phase 3

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.

Institutional Fluid Grant Christian Medical College1 site in 1 country120 target enrollmentStarted: February 14, 2025Last updated:

Overview

Phase
Phase 3
Status
Recruiting
Sponsor
Institutional Fluid Grant Christian Medical College
Enrollment
120
Locations
1
Primary Endpoint
To compare two doses of Dexmedetomidine for the reduction of emergence delirium in children undergoing tonsillectomy/adenotonsillectomy with or without myringotomy.

Overview

Brief Summary

Adenotonsillectomy is one of the most common surgeries performed by otorhinolaryngologists in children under general anaesthesia. In addition to nausea, vomiting, severe pain and poor oral intake, emergence delirium after adenotonsillectomy is one of the main reasons for postoperative morbidity, which may delay the discharge, influence the patient ability to return to normal activity, increase the duration of hospital stay and overall medical cost. Emergence delirium causes distress among children, parents and caregivers thereby increasing dissatisfaction towards the quality of care. Postoperative agitation occurs commonly in young children, generally presenting shortly after emergence from general anaesthesia commonly with volatile agents. Studies have found that children can become agitated at any time during their stay in post anaesthesia care unit. Post operative emergence delirium can be associated with several causes including pain, anxiety, physiological compromise and anaesthetic side effect. Emergence delirium in children is frequent but a preventable complication. Many drugs have been used in practice to prevent emergence delirium in children post anaesthesia. One such drug is dexmedetomidine. Dexmedetomidine is a potent selective alpha 2 agonist which has diverse actions providing dose dependent sedation, anxiolysis, analgesia, perioperative sympatholytic action, anaesthetic sparing effects without relevant respiratory compromise. It decreases heart rate, blood pressure and cardiac output in a dose dependent manner with preservation of respiratory function. Because of its favourable sedation characteristics, hemodynamic stability and lack of respiratory depression, dexmedetomidine can be used in paediatric population. It was found that dexmedetomidine offers specific advantages over others drugs that are used for post operative agitation in children after tonsillectomy. Therefore, we plant compare two doses of dexmedetomidine in reduction of emergence delirium after adenotonsillectomy  with or without myringotomy in children in this study.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Participant, Investigator and Outcome Assessor Blinded

Eligibility Criteria

Ages
2.00 Year(s) to 12.00 Year(s) (—)
Sex
All

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

  • 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.

Outcomes

Primary Outcomes

To compare two doses of Dexmedetomidine for the reduction of emergence delirium in children undergoing tonsillectomy/adenotonsillectomy with or without myringotomy.

Time Frame: 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.

Secondary Outcomes

  • 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.(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.)

Investigators

Sponsor
Institutional Fluid Grant Christian Medical College
Sponsor Class
Private medical college
Responsible Party
Principal Investigator
Principal Investigator

Dr Abishma A M

Christian Medical College, Vellore.

Study Sites (1)

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