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Comparison Of a sedative drug with a combination with opioid for awake intubation in Patients with difficult airway.

Comparison of dexmedetomidine alone with dexmedetomidine and fentanyl during awake fibre-optic intubation in patients with difficulty in intubation: A Randomised Clinical Trail - Dexfen

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/03/031760
Enrollment
60
Registered
2021-03-08
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C00-C14- Malignant neoplasms of lip, oral cavity and pharynx

Interventions

Intervention1: Dexmedetomidine: An infusion of 1 mcg/kg dexmedetomidine diluted in normal saline to make it a total volume of 50 ml to be started for 10 mins prior to starting the procedure for awake

Sponsors

IMS and SUM Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. ASA grade I and II 2. Patients with difficult intubation

Exclusion criteria

Exclusion criteria: 1. Refusal of patient to participate in the study 2. ASA grade II/ III 3. Any allergy to dexmedetomidine 4. Patients on any of the following: a. Higher degree of A-V block b. Treatment with ACE Inhibitors, digoxin or beta adrenergic antagonist c. Treatment with alpha-2 agonist d. Long term use of benzodiazepine or TCA e. Treat with anticoagulants 5. Bleeding disorders 6. Pregnant and nursing women 7. Morbid obesity 8. Lack of cooperative and effective communication 9. Patients requiring post operative ventilatory support

Design outcomes

Primary

MeasureTime frame
1. Airway obstruction score was evaluated using a 3 degree scale 2. Intubation score was evaluated according to Vocal cord movement 3. Coughing 4. Limb movement 5. Fiberoptic intubation comfort score indicating patient tolerance; It was evaluated using a 5 point score 6. Ramsay sedation score: using 6 points 7. Patient satisfaction score Timepoint: At the time of attempting awake fibre optic intubation

Secondary

MeasureTime frame
1. Haemodynamic variables: a. heart rate b. systolic blood pressure c. diastolic blood pressure 2. Any episode of oxygen desaturation ( less than 90%) or bradycardia (HR less than 60 beats/minute).Timepoint: Haemodynamic variables: 1. Baseline: Before drug administration. 2. With the start of the airway manipulation technique (20 min after drug administration). 3. Immediately after intubation.

Countries

India

Contacts

Public ContactPriyangshu Koushik

IMS and SUM hospital

bhavna.sriramka@gmail.com7751007807

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026