Study compares two ways of giving sedation one with inhaled dexmedetomidine and IV ketamine, the other with inhaled ketamine and IV dexmedetomidine to see which works better for keeping patients calm and comfortable during a breathing tube placement for jaw and mouth surgery.

Nebulized Dexmedetomidine and Intravenous Ketamine Versus Nebulized Ketamine and Intravenous Dexmedetomidine to facilitate Awake Fiberoptic Nasotracheal Intubation in adult patients undergoing Oromaxillofacial surgeries - A randomized double blind study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/04/083935

Enrollment

Registered

2025-04-02

Start date

Unknown

Completion date

Unknown

Last updated

2025-04-28

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

Conditions

Health Condition 1: - Health Condition 2: D164- Benign neoplasm of bones of skulland face

Interventions

Intervention1: Nebulization dexmedetomidine and intravenous ketamine: Nebulization: 4% Lignocaine - 5ml + Dexmedetomidine 1 mcg/kg diluted with 0.9% normal saline to make it to 7ml Intravenous: Inj. K

Eligibility

Inclusion criteria

Inclusion criteria: 1.Individuals aged between 18 and 65 years scheduled for elective Oromaxillofacial surgery. 2.Patients classified as American society of Anesthesiologists(ASA) physical status 1 and 2 3.Patients with predicted difficult airway (defined as mouth opening less than 2.5 cm, thyromental distance less than 6.5 cm, sternomental distance less than 12.5 cm, or modified Mallampati class III/IV) who are candidates for AFNI

Exclusion criteria

Exclusion criteria: 1.Patients who refuse or uncooperative such as those with mental retardation, lack of communication, blindness, and deafness were excluded from the study. 2.Patients who had coagulation disorders, respiratory or pulmonary disorders, pregnancy or full stomach, increased intracranial pressure or intraocular pressure, and emergency surgeries or allergy to the study drugs or with risk for regurgitation aspiration were excluded from the study.

Design outcomes

Primary

Measure	Time frame
To compare the ease of intubation with the help of intubation score between the groupsTimepoint: During intubation	—

Secondary

Measure	Time frame
To determine the difference in time taken to intubate the patients during Awake Fiberoptic Intubation in both the groupsTimepoint: During intubation;To assess the hemodynamic variables (Heart rate (HR), mean arterial pressure (MAP), and peripheral oxygen saturation (SpO2) in both the groupsTimepoint: T1 Baseline (before starting nebulization) T2 before starting IV study drug infusions T3 - 5 min after starting IV study drug infusions T4 - at the end of IV study drug infusions T5 at the end of nasotracheal intubation T6 5 min after nasotracheal intubation T7 10 min after nasotracheal intubation;To assess the Post-operative Patient satisfaction score, Recall of procedureTimepoint: During postoperative period	—

Measure

Time frame

To determine the difference in time taken to intubate the patients during Awake Fiberoptic Intubation in both the groupsTimepoint: During intubation;To assess the hemodynamic variables (Heart rate (HR), mean arterial pressure (MAP), and peripheral oxygen saturation (SpO2) in both the groupsTimepoint: T1 Baseline (before starting nebulization) T2 before starting IV study drug infusions T3 - 5 min after starting IV study drug infusions T4 - at the end of IV study drug infusions T5 at the end of nasotracheal intubation T6 5 min after nasotracheal intubation T7 10 min after nasotracheal intubation;To assess the Post-operative Patient satisfaction score, Recall of procedureTimepoint: During postoperative period

—

Countries

India

Contacts

Public ContactDr S R A N Bhushanam Padala

AIIMS Bhopal

padala.anesth@aiimsbhopal.edu.in7893562302

Outcome results

None listed

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