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.

Keywords

• Dexmedetomidine, Lidocaine, LMA, Pediatrics, Elective

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Study arms

• Active comparator
  Group (D) DEX

  Dose: 0.2 mcg/kg IV in 10 mL saline, infused over 10 min pre-induction.

  Drug: Dexamedomedine

• Active comparator
  Group (L) Lidocaine

  Dose: 1.5 mg/kg IV (max 100 mg) in 10 ml saline over 1 min before induction.

  Drug: Lidocaine (drug)

Interventions

• DrugDexamedomedine

  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

  Also known as: DEX, Precedex

• DrugLidocaine (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

Primary outcomes

1. First-attempt insertion success rate

   The success of the first trial of classic LMA insertion will be assessed. Binary: yes or no.

   Time frame: After induction of anesthesia

Secondary outcomes

1. 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.

   Time frame: After Induction of anesthesia

2. Heart rate

   Monitored continuously and recorded every 15 minutes. Atropine IV will be given if bradycardia occurs.

   Time frame: Every 15 minutes till recovery

3. MAP

   Mean arterial blood pressure

   Time frame: Every 15 minutes

4. Recovery Time

   Time from discontinuation of anesthesia till the child is fully awake.

   Time frame: After cessation of anesthesia administration

5. Postoperative Agitation

   PAED scale 1. The child makes eye contact with the caregiver 2. The child's actions are purposeful 3. The child is aware of his/her surroundings 4. The child is restless 5. The child is inconsolable

   Time frame: In PACU

6. Postoperative Complications

   Laryngeal Spasm, Coughing

   Time frame: 0,1,2,6 hours postoperative.

7. PONV

   PONV grade Patient response 0 Without PONV I Nausea without vomiting II Nausea with vomiting (\< 3 times/d) III Vomiting ≥ 3 times/d

   Time frame: 24 hours postoperative

8. Postoperative sore throat (0-3 scale).

   0 (none) 1. (mild/complaint only upon asking) 2. (moderate/complaint on own) 3. (severe/hoarseness or throat pain).

   Time frame: 24 hours postoperative

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 30878762 ↗
• Ju 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 35016404 ↗
• Gharaei 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 ↗

Individual participant data

Plan to share: Yes

Supporting information: Study protocol