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A study comparing two groups of drug combination for better outcome for intubation in cancer patients.

A study to compare the efficacy of combination regimen of dexmedetomidine and midazolam versus ketofol (ketaminetpropofol) for sedation in awake fiberoptic intubation (AFO) in head and neck cancer patients-a randomized clinical trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/07/054860
Enrollment
140
Registered
2023-07-06
Start date
Unknown
Completion date
Unknown
Last updated
2025-02-03

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: DEXMEDETOMIDINE AND MIDAZOLAM: Inj Midazolam 0.02mg/kg + Inj Dexmedetomidine infusion at 1mcg/kg over 10 mins f/b 0.5mcg/kg/hour Control Intervention1: KETAMINE AND PROPOFOL: Inj Ketofo

Sponsors

Department of Onco- Anaesthesia and Palliative Medicine AIIMS New Delhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with head and neck cancers and anticipated difficult intubation. 2. Patients aged between 18 - 65 years of both genders 3. Patients who upon being explained the procedure are willing to participate in the study, and gave informed consent

Exclusion criteria

Exclusion criteria: 1. Patients who are uncooperative to awake fiberoptic intubation. 2. Patients allergic to drugs/ medication being used in the procedure that is dexmedetomidine, midazolam, ketamine, and propofol. 3. Patients having major cardiac, neurological, hepatic, renal, pulmonary illness or coagulation abnormalities. 4. Patients with uncontrolled diabetes mellitus, hypertension or heart block. 5. Patients who are on beta-blockers. 6. Patients with a history of bleeding diathesis. 7. Patients with bradyarrhythmia. 8. Asthmatic patients. 9. Pregnant women

Design outcomes

Primary

MeasureTime frame
Level of sedation: This will be evaluated by Ramsay sedation scoreTimepoint: 0 MINS, 2 MINS, 3 MINS, 5 MINS—

Secondary

MeasureTime frame
1. Intubation Scores: After insertion of fiberoptic scope to visualization of vocal cords 2. Intubation time: Time from insertion of fiberoptic scope to confirm placement of endotracheal tube. 3. Patient comfort score 4. Patient satisfaction- postoperative period 5. Hemodynamic parameters- Heart rate; Systolic Blood Pressure and Diastolic Blood Pressure; Mean Arterial Pressure; Spo2: Baseline 0 minutes, 2 minutes, 3, 4, 5, 6 minutes 6. Side effects- Intra and postoperative complications within 24 hours Timepoint: Immediate—

Countries

India

Contacts

Public ContactAbhilasha Mishra

Department of Onco anaesthesia and Palliative Medicine, AIIMS New Delhi

drbalbir10@gmail.com

Outcome results

None listed

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