To compare three different doses of dexmedetomidine in patients undergoing awake fibreoptic intubation

Not yet recruiting

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2021/11/037832
• Lead Sponsor: DY Patil Medical College

Brief Summary

Awake nasal fiberoptic intubation (ANFOI) is anestablished method of securing difficult airway recommended for patients withanticipated difficult airway, failed intubation, unstable cervical spine injurywhere optimum positioning for laryngoscopy is difficult to achieve. Bothoptimal intubating conditions and patients’ comfort are paramount while preparingthe patient for fiberoptic intubation. It is essential to prepare the patientsprior to ANFOI. The preparation includes obtundation of airway reflexes,adequate sedation, anxiolysis along with preservation of patent airway andadequate ventilation.

In the present study we will compare three differentdoses of dexmedetomidine for conscious sedation during ANFOI in adult patientsscheduled for elective oro-maxillo-facial and oral malignancy surgeries. Invery few studies dexmedetomidine is used as a single agent for induction forsedation during awake ANFOI. We evaluate 3 different doses of dexmedetomidineto establish conscious safe regimen of sedation

Hence, this study was undertaken to compare thedifferent doses of dexmedetomidine for evaluating intubating conditions duringANFOI

The aim of our study is to compare the effectivenessof different doses of dexmedetomidine for evaluating intubation condition,patient’s tolerance, hemodynamic parameters and incidence of oxygendesaturation, if any.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2021-05-11
• Study Start: 2021-11-30

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1All patient giving consent 2Patient undergoing elective oro-maxillo-facial and oral malignancy surgeries 3Patients >18 years or <60 years 4Patients of either sex 5ASA grade I and II.

Exclusion Criteria

1Patients not consenting 2Patient with coagulopathies or on anticoagulants 3Nasal mass or Adenoids 4Patients with severe renal, hepatic, respiratory or cardiac diseases, infection at the site of the block, pregnancy and neuromuscular disorders 5Patients with any known allergy to dexmedetomidine 6Patients with any contraindication to dexmedetomidine 7Lack of cooperation or effective communication.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare between three different doses of dexmedetomidine for sedation on intubation condition in awake nasotracheal fiberoptic intubation.	To compare pre infusion, 5 mins after infusion, 10 mins after infusion, pre intubation, during intubation and post intubation
The primary objective is to compare between three groups: Intubation score, patients’ tolerance, 3-point assessment score immediately after nasotracheal intubation, hemodynamic parameters and incidence of oxygen desaturation if any.	To compare pre infusion, 5 mins after infusion, 10 mins after infusion, pre intubation, during intubation and post intubation

Secondary Outcome Measures

Name	Time	Method
Secondary objective is to observe side effects of drug, if any	1.5 years

Trial Locations

Locations (1)

DEPARTMENT OF ANESTHESIA ,DY PATIL MEDICAL COLLEGE; 🇮🇳 Thane, MAHARASHTRA, India

DEPARTMENT OF ANESTHESIA ,DY PATIL MEDICAL COLLEGE

🇮🇳Thane, MAHARASHTRA, India

SANYA ARORA

Principal investigator

9027011111

sanya.a24@gmail.com