Anesthesia Emergence DeliriumPOEANCT07433231
Magnesium Sulfate Versus Other Anesthesia Drugs to Reduce Agitation After Adenotonsillectomy in Pediatric Patients
A study testing Magnesium sulfate (MgSO4) infusion, Propofol bolus and Ketamine bolus in people with Anesthesia Emergence Delirium and Adenotonsillar Hypertrophy, run by Ayfer Kaya Gök at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia Emergence Delirium, Adenotonsillar Hypertrophy
- What is being tested?
- Magnesium sulfate (MgSO4) infusion, Propofol bolus and Ketamine bolus
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2023to 3 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- pediatric patients aged 3-10 years
- American Society of Anesthesiologists (ASA) physical status I-II
- scheduled for elective adenotonsillectomy
Who cannot join
- ASA III or higher
- emergency surgery
- communication barriers
- history of allergy to any study medication
- known cognitive or developmental delay.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziosmanpaşa Training and Research Hospital
Istanbul, 34075
About this study
Official title: Different Anesthetic Approaches on Postoperative Emergence Agitation in Pediatric Patients Undergoing Adenotonsillectomy: a Prospective Randomized Study
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.
Read the detailed description
Adenotonsillectomy operations are the most common childhood surgeries. Although they are so common, still adenotonsillectomy procedures remain challenging with increased risks of morbidity and mortality for both the surgeon and the anesthesiologist .
Postanesthetic emergence agitation (POEA) is a temporary state of dissociated consciousness during recovery from general anesthesia, in which the child is irritable, uncooperative, restless, and often crying. Reported incidence ranges from 10% to 80%, and POEA is particularly common after ear, nose, and throat (ENT) procedures, including adenotonsillectomy. POEA is usually self-limited, children suffer anxiety, fasting , they are afraid of uncertainty, pain and seperation from parents .POEA needs special consideration because it may lead to self-injury, disruption of surgical sites, removal of catheters or tubes, and delayed discharge from the post-anesthesia care unit (PACU).
Various pharmacological strategies have been investigated to reduce POEA, including propofol, ketamine, magnesium sulfate, lidocaine, opioids, benzodiazepines, clonidine, and α2-agonists, with conflicting results . However, the optimal anesthetic strategy to minimize POEA while preserving efficient recovery remains unclear. The investigators therefore designed a prospective randomized study to compare four anesthetic approaches-propofol, ketamine, lidocaine, and magnesium sulfate-on POEA incidence, recovery characteristics, and perioperative complications in children undergoing adenotonsillectomy.
Methods This prospective randomized study was conducted at Gaziosmanpaşa Research and Training Hospital. The study protocol was approved by the institutional Ethics Committee, and written informed consent was obtained from the parents or legal guardians of all participants. The investigators enrolled 100 pediatric patients aged 3-10 years with American Society of Anesthesiologists (ASA) physical status I-II who were scheduled for elective adenotonsillectomy. Exclusion criteria included ASA III or higher, emergency surgery, communication barriers, history of allergy to any study medication, and known cognitive or developmental delay. All children were fasted according to standard guidelines.
Patients were randomized into four groups using a computer-generated sequence:
- Magnesium sulfate (MgSO4) group: MgSO4 infusion (loading dose 30 mg/kg over 10 minutes after intubation, followed by 10 mg/kg/h infusion).
- Propofol group: propofol 1 mg/kg bolus administered before the end of surgery.
- Ketamine group: ketamine 2 mg/kg bolus administered after induction.
- Lidocaine group: lidocaine 1.5 mg/kg infusion over 15 minutes after induction. All patients received the same premedication (intravenous 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 intravenously as part of a multimodal analgesic regimen.
Hemodynamic variables were recorded intraoperatively. After emergence, the investigators documented time to eye opening, surgery duration, postoperative complications, need for rescue analgesia, and nausea and vomiting (PONV). Duration of stay in the post-anesthesia care unit ( PACU) was recorded from arrival until the discharge. Vital signs and pain-delirium scales were assessed at 5 and 15 minutes in the PACU and at 2 hours postoperatively in the ward . The following scales were used: Face, Legs, Activity, Cry, Consolability (FLACC) pain score , Pediatric Anesthesia Emergence Delirium (PAED) score, Modified Aldrete Score (MAS). Anesthesiologists responsible for intraoperative management did not participate in postoperative assessments.
- Being tested
- Magnesium sulfate (MgSO4) infusion, Propofol bolus, Ketamine bolus, Lidocaine Infusion
- Keywords
- Adenotonsillectomy, Postoperative emergence agitation, Pediatric anesthesia
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium sulfate (MgSO4) infusionDrug
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)."
Propofol bolusDrug
IV propofol 1 mg/kg bolus administered before the end of surgery (timing per protocol).
Ketamine bolusDrug
IV ketamine 2 mg/kg bolus administered after induction.
Lidocaine InfusionDrug
IV lidocaine 1.5 mg/kg administered as an infusion over 15 minutes after induction.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: 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. Receives: 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. Receives: Drug: Lidocaine Infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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)
Postoperative nausea and vomiting (PONV) will be assessed in the post-anesthesia care unit (PACU). PONV will be defined as any episode of nausea (patient report) and/or vomiting/retching (observed). The outcome will be recorded as the proportion of participants who experience PONV and the number of vomiting/retching episodes. Administration of rescue antiemetic medication during the assessment period will also be recorded.
Measured: From PACU arrival (0 minutes) up to 120 minutes postoperatively
Time to eye opening after discontinuation of anesthetic agents
Time to eye opening will be defined as the elapsed time from discontinuation of anesthetic agents at the end of surgery to the first observed spontaneous eye opening, assessed by a trained observer in the operating room and/or during transfer to the PACU. The outcome will be recorded in minutes for each participant.
Measured: 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)
PACU length of stay will be defined as the elapsed time from PACU arrival to PACU discharge readiness and actual discharge per institutional criteria, documented in the medical record. The outcome will be recorded in minutes for each participant.
Measured: From PACU arrival until PACU discharge up to 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2026
- Study start1 Nov 2023
- Primary completion1 Nov 2024
- Study completion3 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Anesthesia Emergence DeliriumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ayfer Kaya Gök
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Ayfer Kaya Gök, Gaziosmanpasa Research and Education Hospital
- Investigators
- Ayfer Kaya Gök, Principal investigator, gaziosmanpaşa training and research hospital md
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07433231
- Sponsor's protocol ID
- 2023-65
- Acronym
- POEA
- Status last verified
- Jan 2026
- First submitted
- 26 Nov 2025
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25587364Mohkamkar 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.
PubMed 25535538Mason 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.
PubMed 28203739Hadi 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.
PubMed 25770644Koo 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.
PubMed 34861083Haile 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.
PubMed 34484732
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Different Anesthetic Approaches on Postoperative Emergence Agitation in Pediatric Patients Undergoing Adenotonsillectomy: a Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT07433231
- Acronym / sponsor ID
- POEA / 2023-65
- Keywords
- Adenotonsillectomy, Postoperative emergence agitation, Pediatric anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ayfer Kaya GökOther government
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 3 Mar 2025 (actual)
- First posted
- 25 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Adenotonsillectomy operations are the most common childhood surgeries. Although they are so common, still adenotonsillectomy procedures remain challenging with increased risks of morbidity and mortality for both the surgeon and the anesthesiologist .
Postanesthetic emergence agitation (POEA) is a temporary state of dissociated consciousness during recovery from general anesthesia, in which the child is irritable, uncooperative, restless, and often crying. Reported incidence ranges from 10% to 80%, and POEA is particularly common after ear, nose, and throat (ENT) procedures, including adenotonsillectomy. POEA is usually self-limited, children suffer anxiety, fasting , they are afraid of uncertainty, pain and seperation from parents .POEA needs special consideration because it may lead to self-injury, disruption of surgical sites, removal of catheters or tubes, and delayed discharge from the post-anesthesia care unit (PACU).
Various pharmacological strategies have been investigated to reduce POEA, including propofol, ketamine, magnesium sulfate, lidocaine, opioids, benzodiazepines, clonidine, and α2-agonists, with conflicting results . However, the optimal anesthetic strategy to minimize POEA while preserving efficient recovery remains unclear. The investigators therefore designed a prospective randomized study to compare four anesthetic approaches-propofol, ketamine, lidocaine, and magnesium sulfate-on POEA incidence, recovery characteristics, and perioperative complications in children undergoing adenotonsillectomy.
Methods This prospective randomized study was conducted at Gaziosmanpaşa Research and Training Hospital. The study protocol was approved by the institutional Ethics Committee, and written informed consent was obtained from the parents or legal guardians of all participants. The investigators enrolled 100 pediatric patients aged 3-10 years with American Society of Anesthesiologists (ASA) physical status I-II who were scheduled for elective adenotonsillectomy. Exclusion criteria included ASA III or higher, emergency surgery, communication barriers, history of allergy to any study medication, and known cognitive or developmental delay. All children were fasted according to standard guidelines.
Patients were randomized into four groups using a computer-generated sequence:
- Magnesium sulfate (MgSO4) group: MgSO4 infusion (loading dose 30 mg/kg over 10 minutes after intubation, followed by 10 mg/kg/h infusion).
- Propofol group: propofol 1 mg/kg bolus administered before the end of surgery.
- Ketamine group: ketamine 2 mg/kg bolus administered after induction.
- Lidocaine group: lidocaine 1.5 mg/kg infusion over 15 minutes after induction. All patients received the same premedication (intravenous 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 intravenously as part of a multimodal analgesic regimen.
Hemodynamic variables were recorded intraoperatively. After emergence, the investigators documented time to eye opening, surgery duration, postoperative complications, need for rescue analgesia, and nausea and vomiting (PONV). Duration of stay in the post-anesthesia care unit ( PACU) was recorded from arrival until the discharge. Vital signs and pain-delirium scales were assessed at 5 and 15 minutes in the PACU and at 2 hours postoperatively in the ward . The following scales were used: Face, Legs, Activity, Cry, Consolability (FLACC) pain score , Pediatric Anesthesia Emergence Delirium (PAED) score, Modified Aldrete Score (MAS). Anesthesiologists responsible for intraoperative management did not participate in postoperative assessments.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Magnesium sulfate (MgSO4) group | Active comparator | Drug: Magnesium sulfate (MgSO4) infusionAll 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). |
| Propofol group | Active comparator | Drug: Propofol bolusAll 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. |
| Ketamine group | Active comparator | Drug: Ketamine bolusAll 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. |
| Lidocaine group | Active comparator | Drug: Lidocaine InfusionAll 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. |
Who may qualify
- Ages
- 3 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- pediatric patients aged 3-10 years
- American Society of Anesthesiologists (ASA) physical status I-II
- scheduled for elective adenotonsillectomy
Key exclusion criteria (5 listed)
- ASA III or higher
- emergency surgery
- communication barriers
- history of allergy to any study medication
- known cognitive or developmental delay.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnesium sulfate (MgSO4) infusionIV 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 | Magnesium sulfate (MgSO4) group |
| Propofol bolusIV propofol 1 mg/kg bolus administered before the end of surgery (timing per protocol). | Drug | Propofol group |
| Ketamine bolusIV ketamine 2 mg/kg bolus administered after induction. | Drug | Ketamine group |
| Lidocaine InfusionIV lidocaine 1.5 mg/kg administered as an infusion over 15 minutes after induction. | Drug | Lidocaine group |
Primary outcome
Postoperative pain in PACU (FLACC score)
Time frame: From PACU arrival (0 minutes) up to 120 minutes postoperatively, assessed at PACU arrival and at 5, 15, and 120 minutes after PACU arrival.
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.
Emergence agitation/delirium in PACU (PAED score)
Time frame: 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 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.
Early recovery status in PACU (Modified Aldrete Score, MAS)
Time frame: From PACU arrival (0 minutes) up to 120 minutes postoperatively, assessed at PACU arrival and at 5, 15, and 120 minutes after PACU arrival.
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.
3 secondary outcomes
postoperative nausea and vomiting (PONV)
Time frame: From PACU arrival (0 minutes) up to 120 minutes postoperatively
Time to eye opening after discontinuation of anesthetic agents
Time frame: 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)
Time frame: From PACU arrival until PACU discharge up to 120 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
- Results publication: PubMed 25587364Becke 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.
- Results publication: PubMed 25535538Mohkamkar 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.
- Results publication: PubMed 28203739Mason 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.
- Results publication: PubMed 25770644Hadi 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.
- Results publication: PubMed 34861083Koo 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.
- Results publication: PubMed 34484732Haile 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ayfer Kaya Gök principal investigator
gaziosmanpaşa training and research hospital md
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnesium sulfate (MgSO4) infusion, Propofol bolus and Ketamine bolus in people with Anesthesia Emergence Delirium and Adenotonsillar Hypertrophy, run by Ayfer Kaya Gök at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain in PACU (FLACC score) (time frame: From PACU arrival (0 minutes) up to 120 minutes postoperatively, assessed at PACU arrival and at 5, 15, and 120 minutes after PACU arrival.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07433231, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2026.