| CTRI Number |
CTRI/2024/05/067555 [Registered on: 17/05/2024] Trial Registered Prospectively |
| Last Modified On: |
02/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
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
|
|
Scientific Title of Study
|
Comparison of Oral Gabapentin vs Nebulized Dexmedetomidine for anxiolysis and hemodynamic stability in awake fiberoptic intubation a Prospective Randomized double blind study.
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Asish Mohapatra |
| Designation |
PG Resident |
| Affiliation |
IMS and SUM HOSPITAL |
| Address |
1st floor, Department of Anesthesiology, IMS and SUM HOSPITAL, Bhubaneswar
Khordha
ORISSA
751019
India |
| Phone |
09438460176 |
| Fax |
|
| Email |
asishmohapatra95@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Shaswat Pattanaik |
| Designation |
Professor and HOD |
| Affiliation |
IMS and SUM HOSPITAL |
| Address |
1st floor, Department of Anesthesiology
Khordha
ORISSA
751003
India |
| Phone |
09438460176 |
| Fax |
|
| Email |
sat.patttnaikk765@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Asish Mohapatra |
| Designation |
PG Resident |
| Affiliation |
IMS and SUM HOSPITAL |
| Address |
1st floor, Department of Anesthesiology
Khordha
ORISSA
751003
India |
| Phone |
09438460176 |
| Fax |
|
| Email |
asishmohapatra95@gmail.com |
|
|
Source of Monetary or Material Support
|
| IMS and SUM HOSPITAL
Shampur, Bhubaneswar
State Odisha, PIN 751003
Country India |
|
|
Primary Sponsor
|
| Name |
IMS SUM HOSPITAL |
| Address |
Shampur, Bhubaneswar, Odisha,
India, PIN 751003 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Asish Mohapatra |
IMS AND SUM HOSPITAL |
1st Floor, Department of Anaesthesiology,
Shampur, Bhubaneswar
Khordha
ORISSA |
09438460176
asishmohapatra95@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IMS and SUM Hospital institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Inj. Dexmedetomidine in nebulized form |
Inj. Dexmeditomidine (undiluted) at 1mcg/kg dosage given via intranasal route using a cirrus nebulizer, 15 mins before procedure |
| Intervention |
Tab. Gabapentin 900mg
|
3 tabs of Gabapentin(300mg each) given orally to patients 2 hours before the procedure in Group G.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients belonging to ASA Grades-I, II status
Patients with difficult airway |
|
| ExclusionCriteria |
| Details |
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 |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
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.
|
Anxiety score will be recorded 15 mins before the procedure(baseline) and during the procedure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare both the groups on basis of hemodynamic stabillity |
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 stimulus |
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 resistance |
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 required |
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 cough |
It will be observed during insertion of the bronchoscope |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "80"
Final Enrollment numbers achieved (India)="80" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
31/05/2024 |
| Date of Study Completion (India) |
10/01/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
10/01/2025 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The purpose of my study is to compare the effect of oral Gabapentin with nebulized Dexmedetomidine in maintaining anxiety & hemodynamic stability in the patients undergoing awake fiberoptic intubation. It is a prospective, double blind, randomized control trial which is to be done over a time period of 1 year. |