Effect of Bolus Versus Low-Dose Infusion Dexmedetomidine on Emergence Agitation in Paediatric Patients Receiving Sevoflurane Anaesthesia.

COMPARISON OF EFFECT OF DEXMEDETOMIDINE AS BOLUS OR LOW-DOSE INFUSION FOR THE PREVENTION OF EMERGENCE AGITATION UNDER SEVOFLURANE ANAESTHESIA IN PAEDIATRIC PATIENTS - nil

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/11/098182

Enrollment

Registered

2025-11-28

Start date

Unknown

Completion date

Unknown

Last updated

2025-12-08

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

Conditions

None listed

Interventions

Intervention1: Group-I bolus dexmedetomidine 0.4 g/kg over 10 min after completion of surgery duration varies from( 1 - 3 hours of surgery): Group-I will receive bolus dexmedetomidine 0.4 g/kg over

Eligibility

Inclusion criteria

Inclusion criteria: 1. ASA classification I-II 2. Age between 2-12 years 3. Undergoing lower abdominal surgery like (Hernia Repair, Orchidopexy, Meckel s Diverticulectomy, Circumcision, Anorectal malformation repair) with sevoflurane anaesthesia.

Exclusion criteria

Exclusion criteria: 1. No consent 2. Developmental delay. 3. Congenital airway or cardiac disorders. 4. History of allergy to study medications. 5. Psychological disorders, epilepsy.

Design outcomes

Primary

Measure	Time frame
To compare the incidence and severity of emergence agitation (EA) between bolus and infusion methods of dexmedetomidine administration.Timepoint: In PACU, the intensity of pain to be assessed by using a modified Hannallah pain score an observational pain score (OPS). Moreover, paediatric anaesthesia emergence delirium (PAED) scale, Ramsay sedation score (RSS) HR, MAP, SpO2 to be measured and recorded on arrival to PACU and 5, 10, 15, 30, 45, 60 min thereafter	—

Measure

Time frame

To compare the incidence and severity of emergence agitation (EA) between bolus and infusion methods of dexmedetomidine administration.Timepoint: In PACU, the intensity of pain to be assessed by using a modified Hannallah pain score an observational pain score (OPS). Moreover, paediatric anaesthesia emergence delirium (PAED) scale, Ramsay sedation score (RSS) HR, MAP, SpO2 to be measured and recorded on arrival to PACU and 5, 10, 15, 30, 45, 60 min thereafter

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Secondary

Measure	Time frame
To evaluate the effect of both methods on extubation time (Duration between the termination of anaesthetic gases & the extubation defined as extubation time) & emergence time (refers to the interval from cessation of anaesthetic agents to the patient s first observable signs of awakening) To assess the hemodynamic stability in both groups To evaluate the postoperative sedation, pain scores, & recovery profiles Timepoint: In PACU, the intensity of pain to be assessed by using a modified Hannallah pain score an observational pain score (OPS). Moreover, paediatric anaesthesia emergence delirium (PAED) scale, Ramsay sedation score (RSS) HR, MAP, SpO2 to be measured & recorded on arrival to PACU & 5, 10, 15, 30, 45, 60 min thereafter.	—

Measure

Time frame

To evaluate the effect of both methods on extubation time (Duration between the termination of anaesthetic gases & the extubation defined as extubation time) & emergence time (refers to the interval from cessation of anaesthetic agents to the patient s first observable signs of awakening) To assess the hemodynamic stability in both groups To evaluate the postoperative sedation, pain scores, & recovery profiles Timepoint: In PACU, the intensity of pain to be assessed by using a modified Hannallah pain score an observational pain score (OPS). Moreover, paediatric anaesthesia emergence delirium (PAED) scale, Ramsay sedation score (RSS) HR, MAP, SpO2 to be measured & recorded on arrival to PACU & 5, 10, 15, 30, 45, 60 min thereafter.

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Countries

India

Contacts

Public ContactSurabhi S Raghav

Armed forces medical college

gunjanafmc@gmail.com09612112136

Outcome results