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Magnesium Sulfate Versus Other Anesthesia Drugs to Reduce Agitation After Adenotonsillectomy in Pediatric Patients

NCT07433231 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-02-25

No results posted yet for this study

Summary

Background: Adenotonsillectomy is one of the most common pediatric surgeries and is often complicated by postoperative emergence agitation (POEA), a short-lived but distressing state of confusion and restlessness after anesthesia. POEA may decrease comfort and increase the risk of perioperative complications.

Objective: To compare four commonly used anesthetic strategies-propofol bolus, ketamine bolus, lidocaine infusion, and magnesium sulfate infusion-with respect to POEA and early recovery quality in children undergoing adenotonsillectomy.

Methods: In this single-center, prospective randomized trial, 100 children aged 3-10 years with American Society of Anesthesiologists (ASA) physical status I-II scheduled for adenotonsillectomy were assigned to one of four anesthetic groups. All patients received standardized premedication, intraoperative management, and multimodal analgesia. Postoperative complications, analgesic requirements, postoperative nausea and vomiting (PONV), time to eye opening, duration of stay in the post-anesthesia care unit (PACU), vital signs, Face, Legs, Activity, Cry, Consolability (FLACC) pain score , Pediatric Anesthesia Emergence Delirium (PAED) score, Modified Aldrete Score (MAS) were recorded and compared.

Conditions

  • Anesthesia Emergence Delirium
  • Adenotonsillar Hypertrophy

Interventions

DRUG

Magnesium sulfate (MgSO4) infusion

IV MgSO4 infusion: Loading dose 30 mg/kg over 10 minutes after tracheal intubation, followed by 10 mg/kg/h continuous infusion (duration per protocol / until end of surgery)."

DRUG

Propofol bolus

IV propofol 1 mg/kg bolus administered before the end of surgery (timing per protocol).

DRUG

Ketamine bolus

IV ketamine 2 mg/kg bolus administered after induction.

DRUG

Lidocaine Infusion

IV lidocaine 1.5 mg/kg administered as an infusion over 15 minutes after induction.

Sponsors & Collaborators

  • Ayfer Kaya Gök

    lead OTHER_GOV

Principal Investigators

  • Ayfer Kaya Gök · gaziosmanpaşa training and research hospital md

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
10 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-11-01
Primary Completion
2024-11-01
Completion
2025-03-03

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07433231 on ClinicalTrials.gov