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 1 site 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
- 1 siteEgypt
- Study dates
- 1 May 2026to 30 Sep 2026
- Phase
- Interventional
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
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mohammed Adel, Lecturer contact
Egypt1 site
Faculty of Medicine Assiut University
Asyut, Asyut Governorate, 71621
Abdelrahman Hamdy, 01060989574, abdelrahmanhm89@gmail.com
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 (estimated)
- Primary completion1 Aug 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
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 (estimated)
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
- Apr 2026
- First submitted
- 25 Apr 2026
- Last updated
- 12 May 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