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Nebulization for fiberoptic intubation

Phase 4
Not yet recruiting
Conditions
Acquired deformity of musculoskeletal system, unspecified,
Registration Number
CTRI/2023/07/054986
Lead Sponsor
M D M Hospital Dr S N Medical College Jodhpur
Brief Summary

Pre-anesthetic evaluation with detailed history, physical examination, and routine investigations will be done for all the patients. Well-informed written consent will be obtained from all the patients. All patients will be premedicated with tab Alprazolam 0.5 mg the night before surgery, tab Ranitidine 150 mg, and a tab Ondansetron 4 mg in the morning 2 hours before the surgery. After shifting the patient to the procedure room, ASA standard monitors will be connected and baseline electrocardiography (ECG), heart rate (HR), noninvasive blood pressure. (NIBP) and Oxygen Saturation (SpO2) will be taken. An IV line will be secured with an 18G Cannula and 500ml Ringer lactate will be started, Patency of both nostrils will be tested and the nostril with better patency will be chosen for Awake Nasal Fiberoptic Intubation. Inj. Glycopyrrolate 0.2 mg IV and intranasal xylometazoline 0.1%, nasal drops will be given in both nostrils prior to nebulization in every patient.

**RANDOMIZATION**

The patients will inhale the nebulized solution from the nebulizer in a semi-reclining position in the procedure room. The patients will be randomly assigned into two groups based on a computer-generated randomization sequence. The two groups will be as follows:

**i.** **Group LD**: Patients will be nebulized with dexmedetomidine 2 mcg/kg (diluted with normal saline (NS) to make a total volume of 2 mL) plus 4 ml of 4%(160mg) lignocaine (total vol. 6ml).

**ii.** **Group LS:** Patients will be nebulized with 4 ml 0f 4% (160mg) lignocaine plus 2 ml of normal saline (NS) (total vol. 6ml).

All the patients will be nebulized over a period of 20 min as per group allocation. At the end of nebulization, adverse effects like signs of lignocaine toxicity, and the level and quality of sedation will be assessed using the Ramsay sedation score. Premedication inj. Fentanyl 2 microgram/kg IV will be given before AFOI. Oropharynx and Hypopharynx will be sprayed with two puffs of 10% lidocaine (each depression of release button delivered 0.1 mL=10 mg, 2puffs = 20mg). The patients will be received supplemental oxygen (2 lit/min) therapy via nasal prong. A well-lubricated fiberoptic bronchoscope preloaded with an appropriate size cuffed endotracheal tube will be inserted through the nostril in the patient lying in the supine position. If a cough reflex will present during FFB, the spray as you go technique will be used as a supplementary LA technique when the patient has partial pharyngeal or transtracheal anesthesia. In this method, a quick pulse of 2 ml 2 % lidocaine will be injected through the working channel of the fiberoptic bronchoscope when the tip of the bronchoscope reaches areas with insufficient anesthesia. In case of cough and gag reflexes still present during FFB If the patient tolerance score during the procedure was 3 or if the anesthesiologist will uncomfortable, an additional sedative in the form of intermittent incremental doses of Propofol 20 mg IV will be given in either of the groups to subside the reflexes, during AFOI procedure, vitals parameters like HR, MAP, and SPO2 will be monitored at 0 min (baseline), 10 min after nebulization, 20 min after nebulization every minute for first 5 minutes, immediately after intubation, followed by every 5 minutes after AFOI for first 20 minutes, and throughout the procedure and the lowest reading will be noted. After proper placement of ETT in the trachea, general anesthesia will be induced and surgery will be allowed to proceed

Detailed Description

Not available

Recruitment & Eligibility

Status
Not Yet Recruiting
Sex
All
Target Recruitment
50
Inclusion Criteria

American Society of Anesthesiologists (ASA) physical status of I–II, and body mass index (BMI) ≤25 kg/cm2 with anticipated difficult airway will be posted for elective surgery under general anesthesia included in the study.

Exclusion Criteria
  • Patient refusal b.
  • Patients with a history of allergy to the local anesthetic or Dexmedetomidine c.
  • Patients with nasal infection or complete obstruction d.
  • Pregnancy (confirmed by history and card test) and lactation e.
  • Patients with coagulation dysfunction.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
To compare the patients comfort & compliance for intubation in terms of COUGH SCORE using dexmedetomidine as an adjuvant to lignocaine for nebulization & lignocaine alone for nebulization in patients undergoing awake fiberoptic intubation.1 hour
Secondary Outcome Measures
NameTimeMethod
1. RAMSAY SEDATION SCORE2. POST INTUBATION SCORE

Trial Locations

Locations (1)

MDM hospital, Dr. S.N. medical collage, Jodhpur

🇮🇳

Jodhpur, RAJASTHAN, India

MDM hospital, Dr. S.N. medical collage, Jodhpur
🇮🇳Jodhpur, RAJASTHAN, India
Dr Geeta Singariya
Principal investigator
9414803554
geetamanojkamal@gmail.com

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