A clinical trial to compare the effects between single dose dexmedetomidine and propofol in soothing children’s uninhibited excitement or emotion on rousing from general anaesthesia following surgical procedures.

Comparison of single bolus dexmedetomidine and propofol for treatment of emergence delirium in children following general anesthesia: a randomized, double blind, controlled trial.

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/06/053507

Enrollment

Registered

2023-06-02

Start date

Unknown

Completion date

Unknown

Last updated

2024-01-22

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

Conditions

Health Condition 1: 8- Other Procedures

Interventions

Intervention1: Pharmaceutical intervention: Sixty (60) patients (Children) will be randomly divided into two equal groups namely Group- D (Dexmedetomidine group) and Group- P (Propofol Group). Every p

Eligibility

Inclusion criteria

Inclusion criteria: 1.Children belonging to ASA grade I and grade II, 2.Children undergoing various surgical procedures under general anaesthesia .

Exclusion criteria

Exclusion criteria: •Parent’s refusal to participate. •Patients having known allergy to either of study drugs. •Patients who did not experience ED during the postoperative period. •Those who developed ED and with the PAED score •Patients having remarkable history of cardio vascular, metabolic or psychological disorder. •Patients requiring sedative medication prior to going to the operation theatre. •Cognitive impairment or communication disorders. •Patients having difficult airway. •Patients having medications that effect heart rate or blood pressure.

Design outcomes

Primary

Measure	Time frame
1.The PAED score. 2.Recovery time.Timepoint: 1.PAED score will be recorded at 5-min intervals (repeated if necessary), 2. Recovery time will be recorded from arrival in the PACU until the time of spontaneous eye-opening or response to verbal command.	—

Secondary

Measure	Time frame
1. Incidences of bradycardia and hypotension, if occurs, will be recorded. 2.Sedation will be assessed using the Stewards simplified postanesthesia recovery score. 3.Pain will be evaluated using the face, legs, activity, cry, consolability (FLACC) scale. 4.Other adverse events such as apnea, oxygen desaturation, laryngospasm, nausea, and emesis will also be recorded.Timepoint: 1. Incidences of bradycardia/hyotension- at one min interval, 2.Sedation (Stewards simplified postanesthesia recovery score) at 5 min intervals. 3.Pain will be evaluated using (FLACC scale)- at 15, 30 60 and 90 mins 4. Other adverse events- if occurs.	—

Measure

Time frame

1. Incidences of bradycardia and hypotension, if occurs, will be recorded. 2.Sedation will be assessed using the Stewards simplified postanesthesia recovery score. 3.Pain will be evaluated using the face, legs, activity, cry, consolability (FLACC) scale. 4.Other adverse events such as apnea, oxygen desaturation, laryngospasm, nausea, and emesis will also be recorded.Timepoint: 1. Incidences of bradycardia/hyotension- at one min interval, 2.Sedation (Stewards simplified postanesthesia recovery score) at 5 min intervals. 3.Pain will be evaluated using (FLACC scale)- at 15, 30 60 and 90 mins 4. Other adverse events- if occurs.

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Countries

India

Contacts

Public ContactDr Diganta Saikia

Assam Medical College

drdigantasaikia@gmail.com9435032626

Outcome results

None listed

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