---
title: Dexmedetomidine Reduces Emergence Delirium in Children Undergoing Tonsillectomy With Propofol Anesthesia
nct_id: NCT03131375
overall_status: COMPLETED
phase: PHASE2, PHASE3
sponsor: "Athens General Children's Hospital \"Pan. & Aglaia Kyriakou\""
study_type: INTERVENTIONAL
primary_condition: Emergence Delirium
countries: Greece
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03131375.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03131375"
ct_last_update_post_date: 2018-07-09
last_seen_at: "2026-05-12T07:14:34.914Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Dexmedetomidine Reduces Emergence Delirium in Children Undergoing Tonsillectomy With Propofol Anesthesia

**Official Title:** Dexmedetomidine Reduces Emergence Delirium in Children Undergoing Tonsillectomy With Propofol Anesthesia: a Prospective, Randomized, Double-blind, Single-center Study.

**NCT ID:** [NCT03131375](https://clinicaltrials.gov/study/NCT03131375)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE2, PHASE3
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 60
- **Lead Sponsor:** Athens General Children's Hospital "Pan. & Aglaia Kyriakou"
- **Conditions:** Emergence Delirium, Extubation Time, Heart Rate, Postoperative Analgesia, Blood Pressure
- **Start Date:** 2017-05-01
- **Completion Date:** 2017-07-30
- **CT.gov Last Update:** 2018-07-09

## Brief Summary

Dexmedetomidine (DEX) is safe and effective in reducing ED following sevoflurane anesthesia. The investigators intend to study the efficacy of DEX in reducing ED in children undergoing tonsillectomy with and without adenoidectomy using total intravenous anesthesia (TIVA) with propofol .

## Eligibility

- **Minimum age:** 3 Years
- **Maximum age:** 14 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* Children
* ASA I or II
* tonsillectomy with or without adenoidectomy

Exclusion Criteria:

* Allergy to dexmedetomidine
* Allergy to anesthetic drugs
* History of neurological disease
* History of neuromuscular disease
* History of renal disease
* History of hepatic disease
* craniofacial anomalies
* History of cardiac disease
* History of respiratory disease
```

## Arms

- **Group A** (ACTIVE_COMPARATOR) — In Group A: Anesthesia induction drugs: propofol , fentanyl , rocuronium iv. After induction, Group A receives a 50 ml NS infusion containing the drug Dexmedetomidine 1 mcg kg-1 slowly. Anesthesia maintainance drugs: propofol and remifentanil. Reversal of neuromuscular block drugs: Sugammadex according to TOF measurements. Postoperative analgesia drugs: nalbuphine 0.16 mg kg-1 . Monitoring devices: ECG, NIBP , ETCO2, SpO2, Bispectral index, Train of four ratio.
- **Group B** (PLACEBO_COMPARATOR) — In Group B: Anesthesia induction drugs: propofol , fentanyl , rocuronium iv. After induction, Group B receives a volume matched normal saline infusion slowly. Anesthesia maintainance drugs: propofol and remifentanil. Reversal of neuromuscular block drugs: Sugammadex according to TOF measurements. Postoperative analgesia drugs: nalbuphine 0.2 mg kg-1 . Monitoring devices: ECG, NIBP , ETCO2, SpO2, Bispectral index, Train of four ratio.

## Interventions

- **Dexmedetomidine** (DRUG) — Group A and B: Anesthesia induction drugs:propofol, fentanyl, rocuronium . After induction of anesthesia: Group A receives a 50 ml NS infusion containing 1 mcg kg-1 Dexmedetomidine drug Group A and B: Atropine as an antisialagogue, dexamethasone, ondasetrone for the prevention of postoperative nausea and vomiting. Anesthesia maintainance: propofol, remifentanil and oxygen in air. End of surgery, the infusion of propofol and remifentanil stop and sugammadex for reversal of neuromuscular block is given. Postoperative analgesia by nalbuphine 0.2 mg kg-1 given before the end of surgery in Group B, and 0.16 mg kg-1 in Group A. Monitoring: ECG, NIBP, ETCO2, SpO2, Bispectral index , Train of four ratio.
- **Normal saline** (DRUG) — Group A and B: Anesthesia induction drugs:propofol, fentanyl, rocuronium . After induction of anesthesia: Group B receives a volume matched Normal saline infusion. Group A and B: Atropine as an antisialagogue, dexamethasone, ondasetrone for the prevention of postoperative nausea and vomiting. Anesthesia maintainance: propofol, remifentanil and oxygen in air. End of surgery, the infusion of propofol and remifentanil stop and sugammadex for reversal of neuromuscular block is given. Postoperative analgesia by nalbuphine 0.2 mg kg-1 given before the end of surgery in Group B. Monitoring: ECG, NIBP, ETCO2, SpO2, Bispectral index, Train of four ratio.
- **Bispectral index** (DEVICE) — Group A and B: Monitoring depth of anesthesia by BIS device and adjusting propofol infusion according to measurements, aiming to BIS values: 40-60
- **Train of four ratio** (DEVICE) — Group A and B: Monitoring recovery of neuromuscular function with TOF-Watch device, to ensure TOFR equals or greater than 90% at the end of the procedure

## Primary Outcomes

- **Emergence delirium in PACU** _(time frame: up to 30 min)_ — Presence or absence of Emergence delirium with and without dexmedetomidine assessed by Watcha scale

## Secondary Outcomes

- **Emergence delirium severity, assessed in PACU** _(time frame: up to 30 min)_
- **Extubation time** _(time frame: up to15 min)_
- **Heart rate** _(time frame: up to 45 min)_
- **Blood pressure** _(time frame: up to 45 min)_

## Locations (1)

- Childrens Hospital P. and A. Kyriakou Anesthesiology Department, Athens, Greece

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.childrens hospital p. and a. kyriakou anesthesiology department|athens||greece` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT03131375.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT03131375*  
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