A study to compare the effect of intravenous versus intranasal dexmedetomidine on restlessness, confusion and vital parameters in children undergoing hypospadias surgery under general anaesthesia

A Randomized controlled study to compare the effect of intravenous versus intranasal dexmedetomidine on emergence delirium and hemodynamics in paediatric patients undergoing hypospadias surgery under general anaesthesia at SMS MEDICAL COLLEGE, JAIPUR - nil

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/06/112766

Enrollment

Registered

2026-06-15

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-22

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: Intravenous Dexmedetomidine: Patient will receive 1ml Intranasal NaCl(0.9%)and Intravenous Dexmedetomidine at 1mcg/kg diluted in 20ml saline for 10 min Intervention2: intranasal dexmede

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients scheduled for elective hypospadias surgery under general anaesthesia. 2. Parent/ Caregiver willing to give consent for participation. 3. Age between 3 to 10 years 4. American Society of Anaesthesiologist (ASA) physical status I and II

Exclusion criteria

Exclusion criteria: 1. Known hypersensitivity or allergy to dexmedetomidine or any component of study formulations. 2. Patients having significant cardiac, hepatic, renal disease, neurological or developmental disorders. 3. Patients with abnormal airways, reactive airway disease. 4. BMI more than 25kg/m2 5. Patients should not participate in another study.

Design outcomes

Primary

Measure	Time frame
1. Mean PAED score recorded during the first 30 min after awakening.Timepoint: Mean PAED score recorded at 10, 20, 30 minutes after awakening	—

Secondary

Measure	Time frame
1. Mean haemodynamic parameters like HR, SBP, DBP, MAP, SpO2. 2. Mean Ramsay sedation score. 3. Mean duration of PACU stay. 4. Mean FLACC score. 5. Mean Duration of analgesia and no. of rescue analgesia required. 6. Percentage of patients with side effects.Timepoint: 1.Mean haemodynamic parameters like HR, SBP, DBP, MAP, SpO2 at baseline, after premedication, after induction, before giving study drug, at 1 min, 5 min, 10 min, 15 min, 30 min, 1 hour after study drug, before and after extubation 2. Mean Ramsay sedation score after awakening, 10, 20, 30 mins, 2, 4, 6, 8 hours after awakening. 3. Mean FLACC score after awakening, 10, 20, 30 mins, 2, 4, 6, 8 hours after awakening.	—

Measure

Time frame

1. Mean haemodynamic parameters like HR, SBP, DBP, MAP, SpO2. 2. Mean Ramsay sedation score. 3. Mean duration of PACU stay. 4. Mean FLACC score. 5. Mean Duration of analgesia and no. of rescue analgesia required. 6. Percentage of patients with side effects.Timepoint: 1.Mean haemodynamic parameters like HR, SBP, DBP, MAP, SpO2 at baseline, after premedication, after induction, before giving study drug, at 1 min, 5 min, 10 min, 15 min, 30 min, 1 hour after study drug, before and after extubation 2. Mean Ramsay sedation score after awakening, 10, 20, 30 mins, 2, 4, 6, 8 hours after awakening. 3. Mean FLACC score after awakening, 10, 20, 30 mins, 2, 4, 6, 8 hours after awakening.

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Countries

India

Contacts

Public ContactDr Komal Agarwal

Sawai Man Singh Medical College, Jaipur

neelam_dogra24@yahoo.com9928709289

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 29, 2026