Comparison between 2 drugs Oral Gabapentin and Nebulized Dexmedetomidine given as premedication before doing awake fiberoptic intubation to control the anxiolysis and hemodynamic stability in the patient

Comparison of Oral Gabapentin vs Nebulized Dexmedetomidine for anxiolysis and hemodynamic stability in awake fiberoptic intubation a Prospective Randomized double blind study. - NIL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/05/067555

Enrollment

Registered

2024-05-17

Start date

Unknown

Completion date

Unknown

Last updated

2025-05-26

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: Tab. Gabapentin 900mg : 3 tabs of Gabapentin(300mg each) given orally to patients 2 hours before the procedure in Group G. Control Intervention1: Inj. Dexmedetomidine in nebulized for

Eligibility

Inclusion criteria

Inclusion criteria: Patients belonging to ASA Grades-I, II status Patients with difficult airway

Exclusion criteria

Exclusion criteria: Refusal of the patient to participate in the study Prolonged duration of procedure (awake fiberoptic intubation) Pt allergic to the study drugs Patients with active URTI Patients with acute facial/nasal trauma history

Design outcomes

Primary

Measure	Time frame
Comparision between the anxiety scores of patients in both intervention and comparator group during the procedure Anxiety score: 0: Patient quiet and comfortable 1: Patient uneasy 2: Patient worried or anxious 3: Patient very worried or very upset. Timepoint: Anxiety score will be recorded 15 mins before the procedure(baseline) and during the procedure	—

Secondary

Measure	Time frame
To compare both the groups on basis of hemodynamic stabillityTimepoint: Observation taken at 1. 15 mins prior to procedure 2. During procedure 3. 1 min, 5min, 10 min and 30 min post procedure;to compare both groups on terms of sedation scoring according to Ramsay scale Ramsay Sedation scale- 1.Anxious, agitated or restless 2.Cooperative, oriented and tranquil 3.Sedated but responds to command 4.Asleep, brisk glabellar reflex, responds to loud noise 5.Asleep, sluggish glabellar reflex or responds to loud noise 6.Asleep with no response to painful stimulusTimepoint: This will be evaluated just prior to insertion of the bronchoscope;To compare the patient comfort score in both the groups Patient comfort score- 1 Cooperative 2 Minimal resistance 3.Severe resistanceTimepoint: it is to be observed during the procedure;To compare airway obstrction score in both groups Airway obstruction score: No obstruction Obstruction relieved by head extension Jaw thrust requiredTimepoint: It will be observed during insertion of fiberoptic bronchoscope;To compare the cough score of both the groups Cough Score- 1.No cough 2.Slight Cough 3.Moderate cough 4.Severe coughTimepoint: It will be observed during insertion of the bronchoscope	—

Measure

Time frame

To compare both the groups on basis of hemodynamic stabillityTimepoint: Observation taken at 1. 15 mins prior to procedure 2. During procedure 3. 1 min, 5min, 10 min and 30 min post procedure;to compare both groups on terms of sedation scoring according to Ramsay scale Ramsay Sedation scale- 1.Anxious, agitated or restless 2.Cooperative, oriented and tranquil 3.Sedated but responds to command 4.Asleep, brisk glabellar reflex, responds to loud noise 5.Asleep, sluggish glabellar reflex or responds to loud noise 6.Asleep with no response to painful stimulusTimepoint: This will be evaluated just prior to insertion of the bronchoscope;To compare the patient comfort score in both the groups Patient comfort score- 1 Cooperative 2 Minimal resistance 3.Severe resistanceTimepoint: it is to be observed during the procedure;To compare airway obstrction score in both groups Airway obstruction score: No obstruction Obstruction relieved by head extension Jaw thrust requiredTimepoint: It will be observed during insertion of fiberoptic bronchoscope;To compare the cough score of both the groups Cough Score- 1.No cough 2.Slight Cough 3.Moderate cough 4.Severe coughTimepoint: It will be observed during insertion of the bronchoscope

—

Countries

India

Contacts

Public ContactDr Asish Mohapatra

IMS and SUM HOSPITAL

sat.patttnaikk765@gmail.com09438460176

Outcome results

None listed

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