comparison of different routes of dexmedetomidine administration in surgical anaesthesia for head and neck cancer patients

A comparison of intravenous dexmedetomidine vs. nebulized dexmedetomidine for awake fiberoptic bronchoscope guided intubation in head and neck surgery: A prospective, double blind, randomized trial. - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/03/083229

Enrollment

128

Registered

2025-03-24

Start date

Unknown

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

Health Condition 1: C049- Malignant neoplasm of floor of mouth, unspecified Health Condition 2: C009- Malignant neoplasm of lip, unspecified Health Condition 3: C069- Malignant neoplasm of mouth, unspecified Health Condition 4: C411- Malignant neoplasm of mandible Health Condition 5: C109- Malignant neoplasm of oropharynx,unspecified Health Condition 6: C490- Malignant neoplasm of connective and soft tissue of head, face and neck Health Condition 7: D103- Benign neoplasm of other and unspecified

Interventions

Intervention1: nebulized dexmedetomidine: I.V normal saline 50ml + (nebulization with dexmedetomidine 1mcg/kg + 4% lignocaine 2.5ml made up to 5ml) Control Intervention1: injection dexmedetomidine: I.

Eligibility

Inclusion criteria

Inclusion criteria: a)The patient giving written and informed consent for study. b)Patient posted for elective head and neck surgeries requiring elective nasal intubation. c)All those patients having anticipated difficult airway. d)Patients with ASA grade I and II. e)Male and female patients aged between 18-70 years.

Exclusion criteria

Exclusion criteria: a) Patients having a clinical diagnosis of any systemic disease. b) Patients with severe renal or hepatic impairment. c) Patient having any intra oral mass. d) Patients with history of alcohol or drug addiction. e) Patient having any predisposition to intra oral bleeding. f) Patients having allergy to the study drugs. g) Patients with cognitive impairment or communication problem. h) Patient requiring conversion from use of sedative to general anesthesia. i) All pregnant and lactating females.

Design outcomes

Primary

Measure	Time frame
To obtain 5-point intubation comfort score for assessing patient tolerance.Timepoint: At time points from point of insertion of bronchoscope till intubation.	—

Secondary

Measure	Time frame
a) To compare hemodynamic variables and associated changes from intubation. b) To compare time required for intubation from the point of insertion of fibreoptic bronchoscope to successful placement of ET tube. c) To obtain patient satisfaction score after extubation regarding ease and comfort of awake intubation.Timepoint: Record hemodynamic variables before fiberoptic intubation at a. drug loading dose b. 2minutes c. 4minutes d. 6minutes e. 8minutes f. 10minutes Record hemodynamic variables after fiberoptic intubation at a. 2minutes b. 4minutes c. 6minutes d. 8minutes e. 10minutes	—

Measure

Time frame

a) To compare hemodynamic variables and associated changes from intubation. b) To compare time required for intubation from the point of insertion of fibreoptic bronchoscope to successful placement of ET tube. c) To obtain patient satisfaction score after extubation regarding ease and comfort of awake intubation.Timepoint: Record hemodynamic variables before fiberoptic intubation at a. drug loading dose b. 2minutes c. 4minutes d. 6minutes e. 8minutes f. 10minutes Record hemodynamic variables after fiberoptic intubation at a. 2minutes b. 4minutes c. 6minutes d. 8minutes e. 10minutes

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Countries

India

Contacts

Public ContactDR NITESH SINHA

RAJENDRA INSTITUTE OF MEDICAL SCIENCES

drkmukesh@gmail.com8709135297

Outcome results

None listed

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