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

NCT07433231 | Completed

• 1 other identifier: 2023-65
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Adenotonsillectomy; Postoperative emergence agitation; Pediatric anesthesia

Outcome Measures

Primary Outcomes (3)

• Postoperative pain in PACU (FLACC score)

  Postoperative pain will be assessed in the post-anesthesia care unit (PACU) using the Face, Legs, Activity, Cry, Consolability (FLACC) pain score (range 0-10; higher scores indicate more severe pain). FLACC will be recorded by a trained observer at PACU arrival and at predefined time points up to 2 hours postoperatively. Primary metric will be the maximum FLACC recorded within 120 minutes after PACU arrival.

  From PACU arrival (0 minutes) up to 120 minutes postoperatively, assessed at PACU arrival and at 5, 15, and 120 minutes after PACU arrival.

• Emergence agitation/delirium in PACU (PAED score)

  Emergence agitation/delirium will be assessed in the PACU using the Pediatric Anesthesia Emergence Delirium (PAED) score (range 0-20; higher scores indicate more severe agitation/delirium). PAED will be recorded by a trained observer at PACU arrival and at predefined time points up to 2 hours postoperatively. The primary metric will be the maximum PAED score observed within the first 2 hours in the PACU. Primary metric will be the maximum PAED recorded within 120 minutes after PACU arrival.

  From PACU arrival (0 minutes) up to 120 minutes postoperatively, assessed at PACU arrival and at 5, 15, and 120 minutes after PACU arrival.

• Early recovery status in PACU (Modified Aldrete Score, MAS)

  Recovery status will be assessed in the PACU using the Modified Aldrete Score (MAS) (range 0-10; higher scores indicate better recovery). MAS will be recorded by a trained observer at PACU arrival and at predefined time points up to 2 hours postoperatively. The primary metric will be the minimum MAS observed within the first 2 hours in the PACU.

  From PACU arrival (0 minutes) up to 120 minutes postoperatively, assessed at PACU arrival and at 5, 15, and 120 minutes after PACU arrival.

Secondary Outcomes (3)

• postoperative nausea and vomiting (PONV)

  From PACU arrival (0 minutes) up to 120 minutes postoperatively

• Time to eye opening after discontinuation of anesthetic agents

  From discontinuation of anesthetic agents at the end of surgery to the time of first spontaneous eye opening, assessed from end of surgery up to 2 hours postoperatively

• Length of stay in the post-anesthesia care unit (PACU)

  From PACU arrival until PACU discharge up to 120 minutes

Study Arms (4)

Magnesium sulfate (MgSO4) group

ACTIVE COMPARATOR

All patients received the same premedication (IV midazolam 0.1 mg/kg) and standardized induction with fentanyl 1 μg/kg, propofol 2 mg/kg, and rocuronium 0.5 mg/kg. After tracheal intubation, anesthesia was maintained with sevoflurane in an oxygen/air mixture. At the end of surgery, all patients received dexamethasone 0.2 mg/kg and acetaminophen 20 mg/kg IV as part of a multimodal analgesic regimen. Participants additionally received MgSO4 infusion per protocol (loading dose 30 mg/kg over 10 minutes after intubation, followed by 10 mg/kg/h infusion).

Drug: Magnesium sulfate (MgSO4) infusion

Propofol group

ACTIVE COMPARATOR

All patients received the same premedication (IV midazolam 0.1 mg/kg) and standardized induction with fentanyl 1 μg/kg, propofol 2 mg/kg, and rocuronium 0.5 mg/kg. After tracheal intubation, anesthesia was maintained with sevoflurane in an oxygen/air mixture. At the end of surgery, all patients received dexamethasone 0.2 mg/kg and acetaminophen 20 mg/kg IV as part of a multimodal analgesic regimen. Participants additionally received propofol 1 mg/kg bolus before the end of surgery.

Drug: Propofol bolus

Ketamine group

ACTIVE COMPARATOR

All patients received the same premedication (IV midazolam 0.1 mg/kg) and standardized induction with fentanyl 1 μg/kg, propofol 2 mg/kg, and rocuronium 0.5 mg/kg. After tracheal intubation, anesthesia was maintained with sevoflurane in an oxygen/air mixture. At the end of surgery, all patients received dexamethasone 0.2 mg/kg and acetaminophen 20 mg/kg IV as part of a multimodal analgesic regimen. Participants additionally received ketamine 2 mg/kg bolus administered after induction.

Drug: Ketamine bolus

Lidocaine group

ACTIVE COMPARATOR

All patients received the same premedication (IV midazolam 0.1 mg/kg) and standardized induction with fentanyl 1 μg/kg, propofol 2 mg/kg, and rocuronium 0.5 mg/kg. After tracheal intubation, anesthesia was maintained with sevoflurane in an oxygen/air mixture. At the end of surgery, all patients received dexamethasone 0.2 mg/kg and acetaminophen 20 mg/kg IV as part of a multimodal analgesic regimen. Participants additionally received lidocaine 1.5 mg/kg infusion over 15 minutes after induction.

Drug: Lidocaine Infusion

Interventions

Magnesium sulfate (MgSO4) infusion DRUG

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)."

Magnesium sulfate (MgSO4) group

Propofol bolus DRUG

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

Propofol group

Ketamine bolus DRUG

IV ketamine 2 mg/kg bolus administered after induction.

Ketamine group

Lidocaine Infusion DRUG

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

Lidocaine group

Eligibility Criteria

• Age: 3 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• pediatric patients aged 3-10 years
• American Society of Anesthesiologists (ASA) physical status I-II
• scheduled for elective adenotonsillectomy

You may not qualify if:

• ASA III or higher
• emergency surgery
• communication barriers
• history of allergy to any study medication
• known cognitive or developmental delay.

Sponsors & Collaborators

• Ayfer Kaya Gök: lead

Study Sites (1)

Gaziosmanpaşa Training and Research Hospital

Istanbul, 34075, Turkey (Türkiye)

Location

Related Publications (6)

• Becke K. Anesthesia for ORL surgery in children. GMS Curr Top Otorhinolaryngol Head Neck Surg. 2014 Dec 1;13:Doc04. doi: 10.3205/cto000107. eCollection 2014.

  PMID: 25587364 RESULT

• Mohkamkar M Bs, Farhoudi F Md, Alam-Sahebpour A Md, Mousavi SA Md, Khani S PhD, Shahmohammadi S BSc. Postanesthetic Emergence Agitation in Pediatric Patients under General Anesthesia. Iran J Pediatr. 2014 Apr;24(2):184-90.

  PMID: 25535538 RESULT

• Mason KP. Paediatric emergence delirium: a comprehensive review and interpretation of the literature. Br J Anaesth. 2017 Mar 1;118(3):335-343. doi: 10.1093/bja/aew477.

  PMID: 28203739 RESULT

• Hadi SM, Saleh AJ, Tang YZ, Daoud A, Mei X, Ouyang W. The effect of KETODEX on the incidence and severity of emergence agitation in children undergoing adenotonsillectomy using sevoflurane based-anesthesia. Int J Pediatr Otorhinolaryngol. 2015 May;79(5):671-6. doi: 10.1016/j.ijporl.2015.02.012. Epub 2015 Feb 19.

  PMID: 25770644 RESULT

• Koo CH, Koo BW, Han J, Lee HT, Lim D, Shin HJ. The effects of intraoperative magnesium sulfate administration on emergence agitation and delirium in pediatric patients: A systematic review and meta-analysis of randomized controlled trials. Paediatr Anaesth. 2022 Apr;32(4):522-530. doi: 10.1111/pan.14352. Epub 2021 Dec 7.

  PMID: 34861083 RESULT

• Haile S, Girma T, Akalu L. Effectiveness of propofol on incidence and severity of emergence agitation on pediatric patients undergo ENT and ophthalmic surgery: Prospective cohort study design. Ann Med Surg (Lond). 2021 Aug 24;69:102765. doi: 10.1016/j.amsu.2021.102765. eCollection 2021 Sep.

  PMID: 34484732 RESULT

MeSH Terms

Conditions

Emergence Delirium

Interventions

Magnesium Sulfate

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Ayfer Kaya Gök

  gaziosmanpaşa training and research hospital md

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Study medications (propofol, ketamine, lidocaine, and magnesium sulfate) are prepared by an anesthesiologist who is involved in intraoperative management . Postop assessment is done by another anesthesiologist. Postoperative outcome assessors remain blinded to group allocation until completion of data collection and database lock.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical doctor

Model Details: Single-center, prospective, randomized, parallel-group trial with four active comparator arms. Eligible children undergoing elective adenotonsillectomy are randomized (1:1:1:1) to receive propofol bolus, ketamine bolus, lidocaine infusion, or magnesium sulfate infusion within a standardized anesthetic protocol, and early postoperative outcomes are compared between groups.

Study Record Dates

• First Submitted: November 26, 2025
• First Posted: February 25, 2026
• Study Start: November 1, 2023
• Primary Completion: November 1, 2024
• Study Completion: March 3, 2025
• Last Updated: February 25, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)