PediatricDEX LMANCT07562308
Laryngeal Mask Airways Are Supraglottic Devices Used to Maintain Airway Patency During Anesthesia and in Difficult Airways. IV Dexmedetomidine Improves LMA Insertion Success and Decreases Coughing, While IV Lidocaine Decreases Postoperative Cough.
A study testing Dexamedomedine and Lidocaine (drug) in people with Pediatric and Elective, run by Assiut University at 2 sites in Egypt.
Trial summary
Laryngeal Mask Airways Are Supraglottic Devices Used to Maintain Airway Patency During Anesthesia and in Difficult Airways. LMA may help in reducing postoperative pulmonary complications. IV Dexmedetomidine Improves LMA Insertion Success and Decreases trials number, While IV Lidocaine Decreases Postoperative Cough. Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Pediatric, Elective, Surgery in Early Childhood
- What is being tested?
- Dexamedomedine and Lidocaine (drug)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 May 2026to 1 Nov 2026
- 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 2 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Parental/guardian consent.
- Age 2-12 years
- ASA physical status I-II.
- Elective surgery requiring LMA (duration <2 hours).
Who cannot join
- Known airway anomalies (e.g., tonsillar hypertrophy, cleft palate).
- Cardiovascular disease (bradycardia, arrhythmias).
- Allergy to study drugs.
- BMI >95th percentile.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Faculty of Medicine Assiut University
Asyut, Asyut Governorate, 71621
Faculty of Medicine
Asyut, Asyut Governorate, 71621
About this study
Official title: Intravenous Dexmedetomidine Vs. Lidocaine for Laryngeal Mask Insertion Conditions In Pediatric Patients Undergoing Elective Surgeries, A Randomized Controlled Trial.
Laryngeal Mask Airways Are Supraglottic Devices Used to Maintain Airway Patency During Anesthesia and in Difficult Airways. LMA may help in reducing postoperative pulmonary complications. IV Dexmedetomidine Improves LMA Insertion Success and Decreases trials number, While IV Lidocaine Decreases Postoperative Cough. This is a randomized interventional trial comparing both drugs. IV DEX will be compared vs IV lidocaine regarding the feasibility of insertion, number of trials, incidence of cough, postoperative pulmonary complications and hemodynamic profile.
- Conditions
- Pediatric, Elective, Surgery in Early Childhood
- Being tested
- Dexamedomedine, Lidocaine (drug)
- Keywords
- Dexmedetomidine, Lidocaine, LMA, Pediatrics, Elective
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamedomedineDrug
Also called DEX, Precedex
IV 0.2 mic/ kg of dexmedetomidine will be diluted over 10 ml saline and given to the patient over 10 minutes before induction and assess the feasibility of classic LMA insertion
Lidocaine (drug)Drug
IV 1.5 mg/kg of lidocaine will be diluted over 10 ml saline and given to the patient 1 minute before induction and assess the feasibility of classic LMA insertion
| Study group | Role | What they receive |
|---|---|---|
| Group (D) DEX | Active comparator | Dose: 0.2 mcg/kg IV in 10 mL saline, infused over 10 min pre-induction. Receives: Drug: Dexamedomedine |
| Group (L) Lidocaine | Active comparator | Dose: 1.5 mg/kg IV (max 100 mg) in 10 ml saline over 1 min before induction. Receives: Drug: Lidocaine (drug) |
What is being measured
The primary outcome is the main question the study is designed to answer.
First-attempt insertion success rate
The success of the first trial of classic LMA insertion will be assessed. Binary: yes or no.
Measured: After induction of anesthesia
Secondary outcomes (8)
Ease of insertion (4-point scale)
Grade 1: No resistance. Grade 2: Mild resistance. Grade 3: Moderate resistance. Grade 4: Failed insertion and need for another airway management tool.
Measured: After Induction of anesthesia
Heart rate
Monitored continuously and recorded every 15 minutes. Atropine IV will be given if bradycardia occurs.
Measured: Every 15 minutes till recovery
MAP
Mean arterial blood pressure
Measured: Every 15 minutes
Recovery Time
Time from discontinuation of anesthesia till the child is fully awake.
Measured: After cessation of anesthesia administration
Postoperative Agitation
PAED scale
- The child makes eye contact with the caregiver
- The child's actions are purposeful
- The child is aware of his/her surroundings
- The child is restless
- The child is inconsolable
Measured: In PACU
Postoperative Complications
Laryngeal Spasm, Coughing
Measured: 0,1,2,6 hours postoperative.
PONV
PONV grade Patient response 0 Without PONV I Nausea without vomiting II Nausea with vomiting (< 3 times/d) III Vomiting ≥ 3 times/d
Measured: 24 hours postoperative
Postoperative sore throat (0-3 scale).
0 (none)
- (mild/complaint only upon asking)
- (moderate/complaint on own)
- (severe/hoarseness or throat pain).
Measured: 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study start1 May 2026
- Primary completion1 Aug 2026
- Study completion1 Nov 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PediatricStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelrahman Hamdy Mohammed, Assiut University
- Investigators
- Abdelrahman Hamdy, Principal investigator, Asyut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07562308
- Sponsor's protocol ID
- DEX and LMA insertion success
- Acronym
- DEX LMA
- Status last verified
- Nov 2026
- First submitted
- 25 Apr 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Li L, Zhang Z, Yao Z, Wang H, Wang H, An H, Yao J. The impact of laryngeal mask versus other airways on perioperative respiratory adverse events in children: A systematic review and meta-analysis of randomized controlled trials. Int J Surg. 2019 Apr;64:40-48. doi: 10.1016/j.ijsu.2019.02.020. Epub 2019 Mar 13.
PubMed 30878762Ju Q, Xiao Z, Sun W, Zhu M, Lv P. The anesthesia induction effect of dexmedetomidine in patients undergoing laryngeal mask intubation: a systematic review and meta-analysis of 7 RCTs. Ann Palliat Med. 2021 Dec;10(12):12358-12366. doi: 10.21037/apm-21-2971.
PubMed 35016404Gharaei B, Jafari A, Poor Zamany M, Kamranmanesh M, Aghamohammadi H, Roodneshin F, Teymourian H, Khazaie Y, Dadkhah P. Topical Versus Intravenous Lidocaine in Children With Upper Respiratory Infection Undergoing Anesthesia: A Randomized, Double Blind, Clinical Trial. Anesth Pain Med. 2015 Aug 22;5(4):e23501. doi: 10.5812/aapm.23501v2. eCollection 2015 Aug.
PubMed 26473098
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Dexmedetomidine Vs. Lidocaine for Laryngeal Mask Insertion Conditions In Pediatric Patients Undergoing Elective Surgeries, A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT07562308
- Acronym / sponsor ID
- DEX LMA / DEX and LMA insertion success
- Conditions
- Pediatric, Elective, Surgery in Early Childhood
- Keywords
- Dexmedetomidine, Lidocaine, LMA, Pediatrics, Elective
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 May 2026 (actual)
- Primary completion
- 1 Aug 2026 (actual)
- Study completion
- 1 Nov 2026 (actual)
- First posted
- 1 May 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.
Laryngeal Mask Airways Are Supraglottic Devices Used to Maintain Airway Patency During Anesthesia and in Difficult Airways. LMA may help in reducing postoperative pulmonary complications. IV Dexmedetomidine Improves LMA Insertion Success and Decreases trials number, While IV Lidocaine Decreases Postoperative Cough. This is a randomized interventional trial comparing both drugs. IV DEX will be compared vs IV lidocaine regarding the feasibility of insertion, number of trials, incidence of cough, postoperative pulmonary complications and hemodynamic profile.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group (D) DEX | Active comparator | Drug: DexamedomedineDose: 0.2 mcg/kg IV in 10 mL saline, infused over 10 min pre-induction. |
| Group (L) Lidocaine | Active comparator | Drug: Lidocaine (drug)Dose: 1.5 mg/kg IV (max 100 mg) in 10 ml saline over 1 min before induction. |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Parental/guardian consent.
- Age 2-12 years
- ASA physical status I-II.
- Elective surgery requiring LMA (duration <2 hours).
Key exclusion criteria (4 listed)
- Known airway anomalies (e.g., tonsillar hypertrophy, cleft palate).
- Cardiovascular disease (bradycardia, arrhythmias).
- Allergy to study drugs.
- BMI >95th percentile.
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 |
|---|---|---|
| DexamedomedineAlso: DEX, PrecedexIV 0.2 mic/ kg of dexmedetomidine will be diluted over 10 ml saline and given to the patient over 10 minutes before induction and assess the feasibility of classic LMA insertion | Drug | Group (D) DEX |
| Lidocaine (drug)IV 1.5 mg/kg of lidocaine will be diluted over 10 ml saline and given to the patient 1 minute before induction and assess the feasibility of classic LMA insertion | Drug | Group (L) Lidocaine |
Primary outcome
First-attempt insertion success rate
Time frame: After induction of anesthesia
The success of the first trial of classic LMA insertion will be assessed. Binary: yes or no.
8 secondary outcomes
Ease of insertion (4-point scale)
Time frame: After Induction of anesthesia
Heart rate
Time frame: Every 15 minutes till recovery
MAP
Time frame: Every 15 minutes
Recovery Time
Time frame: After cessation of anesthesia administration
Postoperative Agitation
Time frame: In PACU
Postoperative Complications
Time frame: 0,1,2,6 hours postoperative.
PONV
Time frame: 24 hours postoperative
Postoperative sore throat (0-3 scale).
Time frame: 24 hours postoperative
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 5 Nov 2026.
- Background: PubMed 30878762Li L, Zhang Z, Yao Z, Wang H, Wang H, An H, Yao J. The impact of laryngeal mask versus other airways on perioperative respiratory adverse events in children: A systematic review and meta-analysis of randomized controlled trials. Int J Surg. 2019 Apr;64:40-48. doi: 10.1016/j.ijsu.2019.02.020. Epub 2019 Mar 13.
- Background: PubMed 35016404Ju Q, Xiao Z, Sun W, Zhu M, Lv P. The anesthesia induction effect of dexmedetomidine in patients undergoing laryngeal mask intubation: a systematic review and meta-analysis of 7 RCTs. Ann Palliat Med. 2021 Dec;10(12):12358-12366. doi: 10.21037/apm-21-2971.
- Background: PubMed 26473098Gharaei B, Jafari A, Poor Zamany M, Kamranmanesh M, Aghamohammadi H, Roodneshin F, Teymourian H, Khazaie Y, Dadkhah P. Topical Versus Intravenous Lidocaine in Children With Upper Respiratory Infection Undergoing Anesthesia: A Randomized, Double Blind, Clinical Trial. Anesth Pain Med. 2015 Aug 22;5(4):e23501. doi: 10.5812/aapm.23501v2. eCollection 2015 Aug.
- 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. This study is not recruiting at the moment.
Abdelrahman Hamdy principal investigator
Asyut University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexamedomedine and Lidocaine (drug) in people with Pediatric and Elective, run by Assiut University at 2 sites 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 4 inclusion and 4 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 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
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?
First-attempt insertion success rate (time frame: After induction of anesthesia). 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 NCT07562308, which also lists 3 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 5 Nov 2026.