A Study to compare the effects of different combination of sedative drugs in patients undergoing surgery for head and neck cancer

A Randomized Study to Compare Efficacy of Combination of Dexmedetomidine and Midazolam versus Fentanyl and Midazolam in Head and Neck Cancer patients for Awake Flexible Nasotracheal Intubation in Department of Anaesthesia SMS Medical College Jaipur - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/06/069417

Enrollment

Registered

2024-06-24

Start date

Unknown

Completion date

Unknown

Last updated

2024-07-22

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

Conditions

Health Condition 1: C148- Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx Health Condition 2: O- Medical and Surgical Health Condition 3: O- Medical and Surgical

Interventions

Intervention1: Awake nasotracheal intubation: Awake nasotracheal intubation using flexible bronchoscope in which group 1 will be receiving Midazolam 0.03mg/kg and an infusion of Dexmedetomidine 1mcg/k

Eligibility

Inclusion criteria

Inclusion criteria: Patient undergoing head and neck cancer surgeries requiring awake nasotracheal intubation with flexible bronchoscope, patient willing to participate in the study, adult patient aged between 30-70 years of either gender, patient belonging to ASA grade I,II,III.

Exclusion criteria

Exclusion criteria: Patients with history of obstructive sleep apnoea, nasal trauma, nasal surgery and bleeding diathesis, patient with history of allergy to the study drugs, non-cooperative or mentally retarded patients.

Design outcomes

Primary

Measure	Time frame
1-Mean time required for intubation in minutes 2-Sedation score-Observers Assessment of Alertness score/Sedation Score (OAA/S) 3-ease of intubation scoreTimepoint: 1-Baseline 2-10 minutes after the drug infusion 3-one minute post intubation	—

Secondary

Measure	Time frame
Mean of Haemodynamic parameters (HR,SpO2, SBP, DBP, MAP), proportion of cases with complications, recall of procedureTimepoint: Just after surgery, 1 hour after surgery	—

Countries

India

Contacts

Public ContactDr Sushil Kumar Bhati

SMS Medical College Jaipur

sakshisharma060296@gmail.com9902235223

Outcome results

None listed

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