Clinical trial NCT04509960: Different Ways of Airway Management in Elective Minor Surgeries in Geriatric Patients
Official title: Comparison of Airway Placement Conditions and Postoperative Effects of Laryngoscope-guided Laryngeal Mask Placement Methods in Sniffing Position in Geriatric Edentulous Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Comparison of Different Laryngeal Mask Wearing Methods
Keywords: laryngeal mask
Lead sponsor: Ankara Diskapi Training and Research Hospital
Sponsor class: OTHER
First posted: 2020-08-12
Enrollment: 50
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: different ways of airway management in elective minor surgeries of geriatric patients

Detailed description: The investigators will used two different ways of pro-seal laryngeal mask insertion technique (laryngoscopy- guided technique or the standard technique) in elective minor surgeries of geriatric toothless patients.

The investigators will record the respiratory dynamics, heartbeat, systolic, diastolic, mean arterial pressures every 5 minutes during surgery. The investigators will record the laryngeal mask insertion time and oropharyngeal leakage pressure. The investigators will evaluate the placement of a laryngeal mask according to young criteria. The development and severity of coughing, retching, laryngospasm, extremity, and head movement during laryngeal mask placement will be recorded. Bloodstains, sore throat, hoarseness will be recorded on the mask that may develop due to laryngeal mask placement. The investigators will use the Briacombe scoring and Campbell category system to assess the position of laryngeal mask airway devices.

Eligibility criteria: Inclusion Criteria:

1. ASA physical status I or II or III
2. Who were scheduled to minor elective ambulatory surgery (e.g. urology operations)
3. Patients undergoing general anesthesia
4. Those who are planned to wear a laryngeal mask for surgical procedure

Exclusion Criteria:

1. patients with full stomach
2. A history of gastric reflux
3. A history of convulsions, cardiovascular or neuromuscular disease
4. Allergies to the study drugs
5. obese (Body mass index (BMI) ≥ 40 kg / m2)
6. suspected difficult airway and hyper-reactive airway disease

Primary outcomes:
measure: laryngeal mask placement
timeFrame: First minute after laryngeal mask insertio
measure: complications of laryngeal mask insertion
timeFrame: Complications will be evaluated within 1 hour after patient recovery.
Secondary outcomes:
measure: hemodynamic response
timeFrame: Before putting on the Layngeal mask, it will record in beats / minute at 5 minutes for 1 minute and 20 minutes after wearing
measure: insertion time
timeFrame: The investigator will record the insertion time in seconds from the moment the laryngeal mask airway passes the incisors until the end-tidal CO2 is visible.
measure: respiratory dynamics
timeFrame: The first minute after the laryngeal mask insertion, and every 5 minutes thereafter up to the 20th minute
measure: hemodynamic responce
timeFrame: Before putting on the Layngeal mask, it will record in mm Hg at 5 minutes for 1 minute and 20 minutes after wearing
measure: oxygen saturation
timeFrame: Before putting on the Layngeal mask, it will record in %SpO2 at 5 minutes for 1 minute and 20 minutes after wearing
measure: respiratory dynamics
timeFrame: The first minute after the laryngeal mask insertion, and every 5 minutes thereafter up to the 20th minute
measure: respiratory dynamics
timeFrame: The first minute after the laryngeal mask insertion, and every 5 minutes thereafter up to the 20th minute
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: University of Health Siences Diskapi Yildirim Beyazit T&R hospital
Study officials:
References:
citation: Chandan SN, Sharma SM, Raveendra US, Rajendra Prasad B. Fiberoptic assessment of laryngeal mask airway placement: a comparison of blind insertion and insertion with the use of a laryngoscope. J Maxillofac Oral Surg. 2009 Jun;8(2):95-8. doi: 10.1007/s12663-009-0025-8. Epub 2009 Aug 11.
citation: Kim GW, Kim JY, Kim SJ, Moon YR, Park EJ, Park SY. Conditions for laryngeal mask airway placement in terms of oropharyngeal leak pressure: a comparison between blind insertion and laryngoscope-guided insertion. BMC Anesthesiol. 2019 Jan 5;19(1):4. doi: 10.1186/s12871-018-0674-6.
citation: Choo CY, Koay CK, Yoong CS. A randomised controlled trial comparing two insertion techniques for the Laryngeal Mask Airway Flexible in patients undergoing dental surgery. Anaesthesia. 2012 Sep;67(9):986-90. doi: 10.1111/j.1365-2044.2012.07167.x. Epub 2012 Jun 11.