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To compare the effect of dexmedetomidine versus midazolam-ketamine combination for sedation during awake fibre optic nasal intubation in head and neck cancer patients.

A prospective randomized study to compare dexmedetomidine versus midazolam-ketamine combination for sedation during awake fibre optic nasal intubation in head and neck cancer patients at SMS Medical college and attached group of hospitals Jaipur. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/05/110105
Enrollment
80
Registered
2026-05-06
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-01

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

Interventions

Intervention1: Injection Dexmedetomidine 1microgram/kg: Patient will receive Dexmedetomidine 1microgram/kg diluted in 20 ml at infusion rate of 120ml/hour for 10 minutes and at the end of 10 mins 2ml

Sponsors

Department of Anaesthesia Sawai Man Singh Medical College Jaipur
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Head and neck cancer patients with anticipated difficult airway (restricted mouth opening, Modified Mallampatti grade III and IV, limited cervical spine extension) scheduled for elective surgery under general anaesthesia. 2. Patients willing to give written informed consent. Patients aged between 18-65 years with ASA physical status I or II.

Exclusion criteria

Exclusion criteria: 1.Patients with known allergy to dexmedetomidine or ketamine or midazolam. 2. Patients with BMI more than 35. 3. Patients with history suggestive of gastro oesophageal reflex. 4.Pregnant and lactating patients . 5.Patients with hepatic or renal disorder . 6.Patient with history of psychotropic drug intake or drug abuse or long term use of tricyclic antidepressants .

Design outcomes

Primary

MeasureTime frame
1. To assess and compare Ramsay Sedation score, airway obstruction score and overall intubation score between the two groups. 2. To assess and compare cough score and patient tolerance score between the two groups .Timepoint: 1. 5mins after infusion 2. 10mins after infusion 3. FOB insertion 4. ETT insertion in glottis 5. Before GA—

Secondary

MeasureTime frame
1.To assess and compare hemodynamic response (SBP, DBP, MAP, HR) to intubation at various time interval between the two groups. 2.To assess and compare post intubation score, intubation time and ability to recall between the two groups. 3.To assess and compare complications if any.Timepoint: 1. 5mins after infusion 2. 10mins after infusion 3. FOB insertion 4. ETT insertion in glottis 5. Before GA—

Countries

India

Contacts

Public ContactDr Priyamvada Goel

Sawai Man Singh Medical College and Attached Hospitals Jaipur

drmamtasharma@hotmail.com9829566077

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026