An interventional study of Lidocaine Hydrochloride and Distilled Water in Airway Complication of Anesthesia, sponsored by Assiut University. Status unknown. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2017-12-04.
Sponsored by Assiut University · Not applicable, Interventional, and Prevention
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).
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.
Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Inhalation of 10 mL nebulized lidocaine hydrochloride via mask nebulizer 5 min before laryngeal mask insertion.
Drug: Lidocaine Hydrochloride
Inhalation of 10 mL of nebulized distilled water solution via mask nebulizer 5 min before laryngeal mask insertion in the preoperative period.
Drug: Distilled Water
Lidocaine hydrochloride will be used via mask nebulizer before LMA insertion
Also known as: Xylocaine
Distilled Water will be used via mask nebulizer before LMA insertion
Also known as: DW
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
Time frame: within 1 minute of LMA insertion
Heart rate
Beat /min
Time frame: 1, 3, 5 minutes after LMA insertion
Arterial blood pressure
mm Hg
Time frame: 1, 3, 5 minutes after LMA insertion
No study locations are listed for this record.
Plan to share: Undecided
Start is estimated for Nov 2017; primary completion for Apr 2018, 4 months later.
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This study is status unknown, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Lidocaine