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Comaparison of two methods to desensitise the airway to pass a breathing tube in awake patients

Airway Anaesthesia for awake orotracheal fibreoptic intubation. A randomized trial comparing two nerve block techniques

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/07/035144
Enrollment
120
Registered
2021-07-27
Start date
Unknown
Completion date
Unknown
Last updated
2023-01-09

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

Conditions

Health Condition 1: G959- Disease of spinal cord, unspecified

Interventions

Intervention1: Airway anaesthesia by bilateral superior laryngeal nerve block and transtracheal block: In 60 patients airway anaesthesia will be obtained by combination of bilateral superior laryngeal

Sponsors

Sanjay Gandhi Post Graduate Institute of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 18-65 years Patients of either gender ASA I and II patients Cervical spine pathology (cervical bone fractures, ligament instability, degenerative disc diseases, tumours, clinically relevant myelopathy) undergoing elective surgery of the cervical spine Weight over 40 kgs

Exclusion criteria

Exclusion criteria: Patients who declined the awake fibreoptic procedure Contraindications to the administration of glycopyrrolate (e.g. low cardiac output syndrome or clinically relevant tachycardia), midazolam or local anaesthetic agent; Mental disability or forms of delirium; Polytrauma patients and/or oro/nasal/pharyngeal bleeding; Contraindication to the performance of translaryngeal injection (thyroid swelling, local infection, or laryngeal disorder). Pregnant patients, those with coagulopathy and those on anticoagulants or antiplatelet agents Previous history of fibreoptic intubations or redo cervical spine surgeries Patients requiring AFOI but lesions on posterior tongue, pharyngeal or laryngeal areas

Design outcomes

Primary

MeasureTime frame
Evaluate the comfort of AFOI, represented by patientsâ?? cough and gag scores during fibreoptic intubation and tube fixationTimepoint: Immediately after completion of fibreoptic intubation

Secondary

MeasureTime frame
1)Ease of intubation process 2)Time required for successful intubation 3)Cardiovascular effects during the procedure 4)Evaluation of the experience of the awake intubation as satisfied, neutral, dissatisfied or having no recall. 5)Postoperative pain in the throat using a visual scale of 1 to 5 (1, none; 5, unacceptable pain), hoarseness (1, none; 5, aphonia) and difficulty of swallowing (1, none; 5, impossible to swallow Timepoint: 1) Immediately after the procedure 2) Immediately after the procedure 3) Immediately after the procedure 4)24 hours after the procedure when the patient has been extubated 5)24 hours after the procedure when the patient has been extubated

Countries

India

Contacts

Public ContactRudrashish Haldar

Sanjay Gandhi Post Graduate Institute of Medical Sciences

rudrashish@yahoo.com09256543256

Outcome results

None listed

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