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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03361397
Other study ID # 17100246
Secondary ID
Status Not yet recruiting
Phase N/A
First received November 24, 2017
Last updated November 28, 2017
Start date November 30, 2017
Est. completion date April 30, 2018

Study information

Verified date November 2017
Source Assiut University
Contact Mohamed Aly, MD
Phone 00201062011126
Email galalm1967@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary outcome of this study will be the effect of lidocaine nebulization before LMA insertion on LMA insertion score (within 1 minute of LMA insertion) in adult patients undergoing surgery under general anesthesia.

The secondary outcome measures are the effect of LMA insertion on heart rate, arterial blood pressure, SpO2, the first time insertion rate of the LMA, and postoperative complications during LMA removal (soft tissue trauma, coughing, and laryngospasm).


Description:

Patients will be randomly allocated into two groups of equal size to receive lidocaine nebulization, group L (GL) or distilled water nebulization, group W (GW/control). Randomization will be performed using GL and GW registers, which will be placed in sealed envelopes prior to study initiation and opened prior to anesthesia by a physician who will prepare the solution for nebulization and will identify it with the patient number, according to the envelope drawn. Group L patients (n = 40) will receive 10 mL lidocaine 4%, and GW patients (n = 40) will receive 10 mL distilled water (DW) by nebulizer mask 5 min prior to anesthesia. All patients will be preoxygenated with 100% oxygen for 3 minutes via mask gently placed over the face and thereafter Propofol 2.5 mg/kg slowly IV plus Fentanyl 1 µg/kg IV will be used for induction of anesthesia, and isoflurane for maintenance of anesthesia in both groups.

After confirming sufficient level of anesthesia (loss of eye lash reflex and jaw relaxation), the standard technique for LMA insertion (Brain,s method) will be used in both groups. Water based jelly will be applied on the posterior surface of the LMA and pressed along the palato-pharyngeal curve using the index finger. It is finally pushed further down till resistance is felt. A size 3 LMA will be used in women and a size 4 in men. Proper placement of LMA will be confirmed with bilateral equally audible breath sounds, chest movements and square wave capnography. Patients will be allowed to breathe spontaneously after successful LMA insertion.

The overall insertion condition will be assessed via a modified three point scale consisting of six variables, which include:

Mouth opening (3: full; 2: partial; 1: none) Ease of insertion (3: easy; 2: difficult; 1: impossible) Swallowing (3: nil; 2: slight; 1: gross) Coughing or gagging (3: nil; 2: slight; 1: gross) Head or limbs movement (3: nil; 2: slight; 1: gross), and Laryngospasm (3: nil; 2: partial; 1: total). Total score Insertion condition 18 Excellent 16-17 Satisfactory <16 Poor Any failure of insertion in both groups (defined as failure to insert the LMA after 3rd time), will be managed by endotracheal intubation.

At the end of the operation, LMA will be removed under deep anesthesia and replaced with Guedel's airway. Oxygen will be continued with a face mask until full recovery, and then the patients will be moved to the PACU.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 80
Est. completion date April 30, 2018
Est. primary completion date April 2, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- Adult patients (Age >18 yrs)

- ASA grade 1&2

- Scheduled to undergo various elective surgical procedures under general anesthesia using LMA.

Exclusion Criteria:

- Patients requiring endotracheal intubation

- Heavy smokers

- Grossly obese patients (Body mass index >35 kg/m2)

- Patients with suspected difficult airway (Mallampati Grade III or IV)

- Hypersensitivity to the used drugs

- Significant cardiovascular

- Significant pulmonary disease

- liver disease.

Study Design


Related Conditions & MeSH terms

  • Airway Complication of Anesthesia

Intervention

Drug:
Lidocaine Hydrochloride
Lidocaine hydrochloride will be used via mask nebulizer before LMA insertion
Distilled Water
Distilled Water will be used via mask nebulizer before LMA insertion

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

References & Publications (2)

Gupta A, Kaur S, Attri JP, Saini N. Comparative evaluation of ketamine - propofol, fentanyl - propofol and butorphanol-propofol on haemodynamics and laryngeal mask airway insertion conditions. J Anaesthesiol Clin Pharmacol. 2011 Jan;27(1):74-8. — View Citation

Williams KA, Barker GL, Harwood RJ, Woodall NM. Combined nebulization and spray-as-you-go topical local anaesthesia of the airway. Br J Anaesth. 2005 Oct;95(4):549-53. Epub 2005 Aug 26. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary LMA insertion score modified three point scale consisting of six variables, which measures the easiness of LMA insertion. Total score Insertion condition 18 Excellent 16-17 Satisfactory <16 Poor within 1 minute of LMA insertion
Secondary Heart rate Beat /min 1, 3, 5 minutes after LMA insertion
Secondary Arterial blood pressure mm Hg 1, 3, 5 minutes after LMA insertion
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