Emergence Delirium, AnesthesiaPhase 4NCT07268924
The Effect of Propofol Versus Lidocaine on Emergence Agitation in Children Undergoing Tonsillectomy.
A Phase 4 study testing Propofol and Lidocaine %2 ampoule in people with Emergence Delirium, Anesthesia, run by Assiut University at 1 site in Egypt.
Trial summary
This study aim to compare the effect of intravenous propofol versus intravenous lidocaine on emergence agitation in children undergoing tonsillectomy or adenotonsillectomy under general anesthesia. Read more about this study
- Who is it for?
- Ages 4 to 7 years
- Conditions the study is for
- Emergence Delirium, Anesthesia
- What is being tested?
- Propofol and Lidocaine %2 ampoule
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2026to Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 4 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Elective tonsillectomy operation
- pediaterics between ( 4 : 7 ) years old
- ASA I OR II
Who cannot join
- emergency cases as bleeding tonsills
- ASA III OR IV
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Assiut university hospitals
Asyut
Hesham Bahaaeldin Mohamed, Resident doctor, +201069896083, heshambahaa51@gmail.com
About this study
This study aim to compare the effect of intravenous propofol versus intravenous lidocaine on emergence agitation in children undergoing tonsillectomy or adenotonsillectomy under general anesthesia.
Read the detailed description
Tonsillectomy is one of the common surgeries in children, which is associated with many morbidities such as postoperative pain, nausea, vomiting, bleeding, dehydration and emergence agitation .
Emergence agitation (EA) is a prevalent occurance following sevoflorane anesthesia , with an incidence of up to 80% , particularly among preschool children EA is characterised by a dissociated state of consciousness' in which the child displays irritability, anxiety , and inconsolable crying, kicking, or thrashing behavior Furthermore , EA in children can potentially be dangerous as it may lead to incidents such as falling out of bed , removal of surgical dressings , intravenous catheters , increase stress for healthcare providera and parents , higher costs due to prolonged recovery stay .³ The mechanism of EA remains unclear. The proposed risk factors of EA include age ,preoperative anxiety,, type of surgery, emergency operation, use of inhalational anesthetics , long duration of surgery.
Several pharmacological prophylactic interventions ,including opioids analgesics , benzodiazepines, α2-adrenergic receptor agonists such as clonidine , have been studied for their potential to reduce incedence of EA .
Propofol, short acting intravenous anesthetic, is known for smoother emergence and sedative properties. Lidocaine, administered intravenously, has analgesic, anti-inflammatory, and sedative effects. There is limited direct comparison between these two drugs specifically in pediatrc tonsillectomy with EA.
So, does intravenous lidocaine compared with propofol reduce the incidence and severity of emergence agitation in children undergoing tonsillectomy or adenotonsillectomy ?
- Conditions
- Emergence Delirium, Anesthesia
- Being tested
- Propofol, Lidocaine %2 ampoule
- Keywords
- Emergence agitation in 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.
PropofolDrug
In pediatric tonsillectomy after the end of surgery, patient will recieve 1 mg/kg of propofol iv bolus
Lidocaine %2 ampouleDrug
In pediatric tonsillectomy after the end of the surgery , patient will recieve 1.5 mg/kg of lidocaine iv bolus
| Study group | Role | What they receive |
|---|---|---|
| Group ( p ) recieve 1mg /kg of propofol | Active comparator | Not described Receives: Drug: Propofol |
| Group ( L ) recieve 1.5 mg/kg of lidocaine | Active comparator | Not described Receives: Drug: Lidocaine %2 ampoule |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the incidence and severity of emergence agitation (EA) between children receiving propofol and those receiving lidocaine using Pediatric Anesthesia Emergence Delirium (PAED) scale.
Pediatric Anesthesia Emergence Delirium (PAED) scale (range 0-20; higher scores indicate more severe agitation).
Measured: Within 30 minutes after extubation
To compare the incidence and severity of emergence agitation (EA) between children receiving propofol and those receiving lidocaine using WATCHA scale
Watcha agitation scale (range 0-4; higher scores indicate more severe agitation).
Measured: Within 30 minutes after extubation.
Secondary outcomes (6)
emergence time from anesthesia
Measured: Within 30 minutes after extubation.
peaked PAED scores
Pediatric Anesthesia Emergence Delirium (PAED) scale (range 0-20; higher scores indicate more severe agitation).
Measured: Within 30 minutes after extubation.
extubation time
Measured: Within 30 minutes after extubation.
post-operative pain using FLACC score
The FLACC scale is used to assess postoperative pain in children. It consists of 5 categories (Face, Legs, Activity, Cry, Consolability), each scored 0-2, giving a total score range of 0-10.
Measured: Within 30 minutes after extubation.
Hemodynamic effects as hypotention and bradycardia
Measured: Within 30 minutes after extubation.
Post operative nausea and vomitting
Measured: Within 30 minutes after extubation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2025
- Study startJan 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Emergence Delirium, AnesthesiaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hesham Bahaa-eldin Mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07268924
- Sponsor's protocol ID
- EA-CHT-PvL-2025
- Status last verified
- Dec 2025
- First submitted
- 24 Sep 2025
- Last updated
- 8 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Ahmed SA, Omara AF. The Effect of Glossopharyngeal Nerve Block on Post-Tonsillectomy Pain of Children; Randomized Controlled Trial. Anesth Pain Med. 2019 Apr 30;9(2):e90854. doi: 10.5812/aapm.90854. eCollection 2019 Apr.
PubMed 31341828Ji JY, Park JS, Kim JE, Kim DH, Chung JH, Chun HR, Jung HS, Yoo SH. Effect of esmolol and lidocaine on agitation in awake phase of anesthesia among children: a double-blind, randomized clinical study. Chin Med J (Engl). 2019 Apr 5;132(7):757-764. doi: 10.1097/CM9.0000000000000141.
PubMed 30741832Manouchehrian N, Jiryaee N, Moheb FA. Propofol versus lidocaine on prevention of laryngospasm in tonsillectomy: A randomized clinical trial. Eur J Transl Myol. 2022 Jun 29;32(3):10581. doi: 10.4081/ejtm.2022.10581.
PubMed 35766592Watcha MF, Ramirez-Ruiz M, White PF, Jones MB, Lagueruela RG, Terkonda RP. Perioperative effects of oral ketorolac and acetaminophen in children undergoing bilateral myringotomy. Can J Anaesth. 1992 Sep;39(7):649-54. doi: 10.1007/BF03008224.
PubMed 1394752Sikich N, Lerman J. Development and psychometric evaluation of the pediatric anesthesia emergence delirium scale. Anesthesiology. 2004 May;100(5):1138-45. doi: 10.1097/00000542-200405000-00015.
PubMed 15114210Clivio S, Putzu A, Tramer MR. Intravenous Lidocaine for the Prevention of Cough: Systematic Review and Meta-analysis of Randomized Controlled Trials. Anesth Analg. 2019 Nov;129(5):1249-1255. doi: 10.1213/ANE.0000000000003699.
PubMed 30169416Mokhtar AM, Badawy AA. [Low dose propofol vs. lidocaine for relief of resistant post-extubation laryngospasm in the obstetric patient]. Braz J Anesthesiol. 2018 Jan-Feb;68(1):57-61. doi: 10.1016/j.bjan.2017.03.009. Epub 2017 Jul 25.
PubMed 28754225Malviya S, Voepel-Lewis T, Ramamurthi RJ, Burke C, Tait AR. Clonidine for the prevention of emergence agitation in young children: efficacy and recovery profile. Paediatr Anaesth. 2006 May;16(5):554-9. doi: 10.1111/j.1460-9592.2006.01818.x.
PubMed 16677266Na HS, Song IA, Hwang JW, Do SH, Oh AY. Emergence agitation in children undergoing adenotonsillectomy: a comparison of sevoflurane vs. sevoflurane-remifentanil administration. Acta Anaesthesiol Scand. 2013 Jan;57(1):100-5. doi: 10.1111/aas.12006. Epub 2012 Oct 30.
PubMed 23110746Kanaya A. Emergence agitation in children: risk factors, prevention, and treatment. J Anesth. 2016 Apr;30(2):261-7. doi: 10.1007/s00540-015-2098-5. Epub 2015 Nov 24.
PubMed 26601849Acar HV, Yilmaz A, Demir G, Eruyar SG, Dikmen B. Capsicum plasters on acupoints decrease the incidence of emergence agitation in pediatric patients. Paediatr Anaesth. 2012 Nov;22(11):1105-9. doi: 10.1111/j.1460-9592.2012.03876.x.
PubMed 22553919Chen J, Shi X, Hu W, Lin R, Meng L, Liang C, Ma X, Xu L. Comparing different administration methods of subanaesthetic propofol to mitigate emergence agitation in preschool children undergoing day surgery: a double-blind, randomised controlled study. BMJ Paediatr Open. 2025 Mar 15;9(1):e002376. doi: 10.1136/bmjpo-2023-002376.
PubMed 40090678Xie M, Li XK, Peng Y. Magnesium sulfate for postoperative complications in children undergoing tonsillectomies: a systematic review and meta-analysis. J Evid Based Med. 2017 Feb;10(1):16-25. doi: 10.1111/jebm.12230.
PubMed 27787936Stalfors J, Ericsson E, Hemlin C, Hultcrantz E, Mansson I, Roos K, Hessen Soderman AC. Tonsil surgery efficiently relieves symptoms: analysis of 54 696 patients in the National Tonsil Surgery Register in Sweden. Acta Otolaryngol. 2012 May;132(5):533-9. doi: 10.3109/00016489.2011.644252. Epub 2012 Jan 11.
PubMed 22235871
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Propofol Versus Lidocaine on Emergence Agitation in Children Undergoing Tonsillectomy.
- ClinicalTrials.gov ID
- NCT07268924
- Acronym / sponsor ID
- EA-CHT-PvL-2025
- Conditions
- Emergence Delirium, Anesthesia
- Keywords
- Emergence agitation in anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jan 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 8 Dec 2025 (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.
This study aim to compare the effect of intravenous propofol versus intravenous lidocaine on emergence agitation in children undergoing tonsillectomy or adenotonsillectomy under general anesthesia.
Detailed description
Tonsillectomy is one of the common surgeries in children, which is associated with many morbidities such as postoperative pain, nausea, vomiting, bleeding, dehydration and emergence agitation .
Emergence agitation (EA) is a prevalent occurance following sevoflorane anesthesia , with an incidence of up to 80% , particularly among preschool children EA is characterised by a dissociated state of consciousness' in which the child displays irritability, anxiety , and inconsolable crying, kicking, or thrashing behavior Furthermore , EA in children can potentially be dangerous as it may lead to incidents such as falling out of bed , removal of surgical dressings , intravenous catheters , increase stress for healthcare providera and parents , higher costs due to prolonged recovery stay .³ The mechanism of EA remains unclear. The proposed risk factors of EA include age ,preoperative anxiety,, type of surgery, emergency operation, use of inhalational anesthetics , long duration of surgery.
Several pharmacological prophylactic interventions ,including opioids analgesics , benzodiazepines, α2-adrenergic receptor agonists such as clonidine , have been studied for their potential to reduce incedence of EA .
Propofol, short acting intravenous anesthetic, is known for smoother emergence and sedative properties. Lidocaine, administered intravenously, has analgesic, anti-inflammatory, and sedative effects. There is limited direct comparison between these two drugs specifically in pediatrc tonsillectomy with EA.
So, does intravenous lidocaine compared with propofol reduce the incidence and severity of emergence agitation in children undergoing tonsillectomy or adenotonsillectomy ?
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group ( p ) recieve 1mg /kg of propofol | Active comparator | Drug: Propofol |
| Group ( L ) recieve 1.5 mg/kg of lidocaine | Active comparator | Drug: Lidocaine %2 ampoule |
Who may qualify
- Ages
- 4 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Elective tonsillectomy operation
- pediaterics between ( 4 : 7 ) years old
- ASA I OR II
Key exclusion criteria (2 listed)
- emergency cases as bleeding tonsills
- ASA III OR IV
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 |
|---|---|---|
| PropofolIn pediatric tonsillectomy after the end of surgery, patient will recieve 1 mg/kg of propofol iv bolus | Drug | Group ( p ) recieve 1mg /kg of propofol |
| Lidocaine %2 ampouleIn pediatric tonsillectomy after the end of the surgery , patient will recieve 1.5 mg/kg of lidocaine iv bolus | Drug | Group ( L ) recieve 1.5 mg/kg of lidocaine |
Primary outcome
To compare the incidence and severity of emergence agitation (EA) between children receiving propofol and those receiving lidocaine using Pediatric Anesthesia Emergence Delirium (PAED) scale.
Time frame: Within 30 minutes after extubation
Pediatric Anesthesia Emergence Delirium (PAED) scale (range 0-20; higher scores indicate more severe agitation).
To compare the incidence and severity of emergence agitation (EA) between children receiving propofol and those receiving lidocaine using WATCHA scale
Time frame: Within 30 minutes after extubation.
Watcha agitation scale (range 0-4; higher scores indicate more severe agitation).
6 secondary outcomes
emergence time from anesthesia
Time frame: Within 30 minutes after extubation.
peaked PAED scores
Time frame: Within 30 minutes after extubation.
extubation time
Time frame: Within 30 minutes after extubation.
post-operative pain using FLACC score
Time frame: Within 30 minutes after extubation.
Hemodynamic effects as hypotention and bradycardia
Time frame: Within 30 minutes after extubation.
Post operative nausea and vomitting
Time frame: Within 30 minutes after extubation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
- Results publication: PubMed 31341828Ahmed SA, Omara AF. The Effect of Glossopharyngeal Nerve Block on Post-Tonsillectomy Pain of Children; Randomized Controlled Trial. Anesth Pain Med. 2019 Apr 30;9(2):e90854. doi: 10.5812/aapm.90854. eCollection 2019 Apr.
- Results publication: PubMed 30741832Ji JY, Park JS, Kim JE, Kim DH, Chung JH, Chun HR, Jung HS, Yoo SH. Effect of esmolol and lidocaine on agitation in awake phase of anesthesia among children: a double-blind, randomized clinical study. Chin Med J (Engl). 2019 Apr 5;132(7):757-764. doi: 10.1097/CM9.0000000000000141.
- Results publication: PubMed 35766592Manouchehrian N, Jiryaee N, Moheb FA. Propofol versus lidocaine on prevention of laryngospasm in tonsillectomy: A randomized clinical trial. Eur J Transl Myol. 2022 Jun 29;32(3):10581. doi: 10.4081/ejtm.2022.10581.
- Results publication: PubMed 1394752Watcha MF, Ramirez-Ruiz M, White PF, Jones MB, Lagueruela RG, Terkonda RP. Perioperative effects of oral ketorolac and acetaminophen in children undergoing bilateral myringotomy. Can J Anaesth. 1992 Sep;39(7):649-54. doi: 10.1007/BF03008224.
- Results publication: PubMed 15114210Sikich N, Lerman J. Development and psychometric evaluation of the pediatric anesthesia emergence delirium scale. Anesthesiology. 2004 May;100(5):1138-45. doi: 10.1097/00000542-200405000-00015.
- Results publication: PubMed 30169416Clivio S, Putzu A, Tramer MR. Intravenous Lidocaine for the Prevention of Cough: Systematic Review and Meta-analysis of Randomized Controlled Trials. Anesth Analg. 2019 Nov;129(5):1249-1255. doi: 10.1213/ANE.0000000000003699.
- Results publication: PubMed 28754225Mokhtar AM, Badawy AA. [Low dose propofol vs. lidocaine for relief of resistant post-extubation laryngospasm in the obstetric patient]. Braz J Anesthesiol. 2018 Jan-Feb;68(1):57-61. doi: 10.1016/j.bjan.2017.03.009. Epub 2017 Jul 25.
- Results publication: PubMed 16677266Malviya S, Voepel-Lewis T, Ramamurthi RJ, Burke C, Tait AR. Clonidine for the prevention of emergence agitation in young children: efficacy and recovery profile. Paediatr Anaesth. 2006 May;16(5):554-9. doi: 10.1111/j.1460-9592.2006.01818.x.
- Results publication: PubMed 23110746Na HS, Song IA, Hwang JW, Do SH, Oh AY. Emergence agitation in children undergoing adenotonsillectomy: a comparison of sevoflurane vs. sevoflurane-remifentanil administration. Acta Anaesthesiol Scand. 2013 Jan;57(1):100-5. doi: 10.1111/aas.12006. Epub 2012 Oct 30.
- Results publication: PubMed 26601849Kanaya A. Emergence agitation in children: risk factors, prevention, and treatment. J Anesth. 2016 Apr;30(2):261-7. doi: 10.1007/s00540-015-2098-5. Epub 2015 Nov 24.
- Results publication: PubMed 22553919Acar HV, Yilmaz A, Demir G, Eruyar SG, Dikmen B. Capsicum plasters on acupoints decrease the incidence of emergence agitation in pediatric patients. Paediatr Anaesth. 2012 Nov;22(11):1105-9. doi: 10.1111/j.1460-9592.2012.03876.x.
- Results publication: PubMed 40090678Chen J, Shi X, Hu W, Lin R, Meng L, Liang C, Ma X, Xu L. Comparing different administration methods of subanaesthetic propofol to mitigate emergence agitation in preschool children undergoing day surgery: a double-blind, randomised controlled study. BMJ Paediatr Open. 2025 Mar 15;9(1):e002376. doi: 10.1136/bmjpo-2023-002376.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Propofol and Lidocaine %2 ampoule in people with Emergence Delirium, Anesthesia, run by Assiut University at 1 site in Egypt.
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 2 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: opening soon, as of the sponsor's last update on 8 Dec 2025. 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 Egypt. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hesham Bahaaeldin Mohamed, Resident doctor (+201069896083, heshambahaa51@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the incidence and severity of emergence agitation (EA) between children receiving propofol and those receiving lidocaine using Pediatric Anesthesia Emergence Delirium (PAED) scale. (time frame: Within 30 minutes after extubation). The study lists 2 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 NCT07268924, which also lists 14 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 8 Dec 2025.