Airway Complication of AnesthesiaNCT03361397
Effect of Nebulized Lidocaine on the Quality of Laryngeal Mask Airway Insertion
A study testing Lidocaine Hydrochloride and Distilled Water in people with Airway Complication of Anesthesia, run by Assiut University.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Airway Complication of Anesthesia
- What is being tested?
- Lidocaine Hydrochloride and Distilled Water
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 30 Nov 2017to 30 Apr 2018
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adult patients (Age >18 yrs)
- ASA grade 1\&2
- Scheduled to undergo various elective surgical procedures under general anesthesia using LMA.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Nebulized Lidocaine on the Quality of Laryngeal Mask Airway Insertion: A Randomized, Double Blind, Controlled Study
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).
Read the detailed 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.
- Conditions
- Airway Complication of Anesthesia
- Being tested
- Lidocaine Hydrochloride, Distilled Water
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine HydrochlorideDrug
Also called Xylocaine
Lidocaine hydrochloride will be used via mask nebulizer before LMA insertion
Distilled WaterDrug
Also called DW
Distilled Water will be used via mask nebulizer before LMA insertion
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine nebulization | Active comparator | Inhalation of 10 mL nebulized lidocaine hydrochloride via mask nebulizer 5 min before laryngeal mask insertion. Receives: Drug: Lidocaine Hydrochloride |
| Distilled water nebulization | Placebo comparator | Inhalation of 10 mL of nebulized distilled water solution via mask nebulizer 5 min before laryngeal mask insertion in the preoperative period. Receives: Drug: Distilled Water |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: within 1 minute of LMA insertion
Secondary outcomes (2)
Heart rate
Beat /min
Measured: 1, 3, 5 minutes after LMA insertion
Arterial blood pressure
mm Hg
Measured: 1, 3, 5 minutes after LMA insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2017
- Study start30 Nov 2017 (estimated)
- Primary completion2 Apr 2018 (estimated)
- Study completion30 Apr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Airway Complication of AnesthesiaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed galal aly, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03361397
- Sponsor's protocol ID
- 17100246
- Status last verified
- Nov 2017
- First submitted
- 24 Nov 2017
- Last updated
- 4 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 21804711Williams 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. doi: 10.1093/bja/aei202. Epub 2005 Aug 26.
PubMed 16126785
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Nebulized Lidocaine on the Quality of Laryngeal Mask Airway Insertion: A Randomized, Double Blind, Controlled Study
- ClinicalTrials.gov ID
- NCT03361397
- Acronym / sponsor ID
- 17100246
- Conditions
- Airway Complication of Anesthesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 30 Nov 2017 (estimated)
- Primary completion
- 2 Apr 2018 (estimated)
- Study completion
- 30 Apr 2018 (estimated)
- First posted
- 4 Dec 2017 (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.
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).
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lidocaine nebulization | Active comparator | Drug: Lidocaine HydrochlorideInhalation of 10 mL nebulized lidocaine hydrochloride via mask nebulizer 5 min before laryngeal mask insertion. |
| Distilled water nebulization | Placebo comparator | Drug: Distilled WaterInhalation of 10 mL of nebulized distilled water solution via mask nebulizer 5 min before laryngeal mask insertion in the preoperative period. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Adult patients (Age >18 yrs)
- ASA grade 1\&2
- Scheduled to undergo various elective surgical procedures under general anesthesia using LMA.
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| Lidocaine HydrochlorideAlso: XylocaineLidocaine hydrochloride will be used via mask nebulizer before LMA insertion | Drug | Lidocaine nebulization |
| Distilled WaterAlso: DWDistilled Water will be used via mask nebulizer before LMA insertion | Drug | Distilled water nebulization |
Primary outcome
LMA insertion score
Time frame: within 1 minute of LMA insertion
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
2 secondary outcomes
Heart rate
Time frame: 1, 3, 5 minutes after LMA insertion
Arterial blood pressure
Time frame: 1, 3, 5 minutes after LMA insertion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2017.
- Background: PubMed 21804711Gupta 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.
- Background: PubMed 16126785Williams 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. doi: 10.1093/bja/aei202. Epub 2005 Aug 26.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Lidocaine Hydrochloride and Distilled Water in people with Airway Complication of Anesthesia, run by Assiut University.
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 3 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 4 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Aly, MD (00201062011126, galalm1967@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LMA insertion score (time frame: within 1 minute of LMA insertion). 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 NCT03361397, which also lists 2 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 4 Dec 2017.