| CTRI Number |
CTRI/2025/10/095825 [Registered on: 09/10/2025] Trial Registered Prospectively |
| Last Modified On: |
04/12/2025 |
| 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
|
Study comparing two types of pre surgery nebulization one with dexmedetomidine and the other with a combination of ketamine and dexmedetomidine to find which is better to prevent sore throat after laparoscopic surgery in adults |
|
Scientific Title of Study
|
Comparison of Nebulization with Dexmedetomidine versus Ketamine-Dexmedetomidine combination for Post-Operative Sore Throat in adult patients undergoing laparoscopic surgery - A Randomised parallel arm 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 Nikhil Badetiya |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences Bhopal |
| Address |
All India Institute of Medical Sciences Bhopal,Department of Anesthesiology,Saket Nagar,462020 Bhopal Madhya Pradesh,462020,INDIA
Bhopal MADHYA PRADESH 462020 India |
| Phone |
8740990681 |
| Fax |
|
| Email |
nikhilbadetiya@yahoo.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Ashutosh Kaushal |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences Bhopal |
| Address |
All India Institute of Medical Sciences Bhopal,Department of Anesthesiology,Saket Nagar,462020 Bhopal Madhya Pradesh,462020,INDIA
Bhopal MADHYA PRADESH 462020 India |
| Phone |
8765515521 |
| Fax |
|
| Email |
ashutosh.anaesth@aiimsbhopal.edu.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Ashutosh Kaushal |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences Bhopal |
| Address |
All India Institute of Medical Sciences Bhopal,Department of Anesthesiology,Saket Nagar,462020 Bhopal Madhya Pradesh,462020,INDIA
Bhopal MADHYA PRADESH 462020 India |
| Phone |
8765515521 |
| Fax |
|
| Email |
ashutosh.anaesth@aiimsbhopal.edu.in |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences Bhopal(Non funded) |
|
|
Primary Sponsor
|
| Name |
Dr Ashutosh Kaushal |
| Address |
All India Institute of Medical Sciences Bhopal,Department of Anesthesiology,Saket Nagar,Bhopal,Madhya Pradesh 462020 |
| Type of Sponsor |
Other [Guide(Additional Professor)] |
|
|
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 Ashutosh Kaushal |
All Institute of Medical Sciences Bhopal |
All Institute of Medical Sciences Bhopal,Department of Anesthesiology,Saket Nagar,Bhopal,Madhya Pradesh,462020 Bhopal MADHYA PRADESH |
8765515521
ashutosh.anaesth@aiimsbhopal.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS,Bhopal Institutional Human Ethics Committee-Student Research(IHEC-SR) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Comparator Agent |
Group 1: Nebulized Dexmedetomidine 1mcg/kg diluted in 4 ml of normal saline |
On the day of surgery, Patients will be nebulized according to their assigned group as follows 40 Patients will be nebulized with dexmedetomidine 1 mcg/kg diluted in 4 ml of
normal saline over 15 minutes. |
| Intervention |
Group 2:Nebulized Dexmedetomidine 1mcg/kg
and Ketamine 0.5mg/kg diluted in 4 ml of normal saline. |
On the day of surgery, Patients will be nebulized according to their assigned group as follows 40 Patients will be nebulized with a combination of dexmedetomidine 1mcg/kg
and ketamine 0.5mg/kg diluted in 4 ml of normal saline over 15 minutes. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients with American Society of Anesthesiologist (ASA) physical status grading I & II. |
|
| ExclusionCriteria |
| Details |
1. Non consenting patients.
2. Allergy to dexmedetomidine or ketamine.
3.Current upper respiratory tract infections, pre-existing sore throat and/or hoarseness.
4.Patients using steroids or nonsteroidal anti-inflammatory drugs.
5.Patients with chronic obstructive pulmonary disease, asthma.
6.Pregnant patients.
7.Any history of difficult intubation, loose teeth.
8.Difficult intubation requiring more than one attempt.
9.Already intubated patients.
10.Patients not extubated at the end of surgery.
11.Patients with sinus bradycardia, atrioventricular block, cardiac disease. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of Postopertive sore throat (POST) between both the groups. |
10 mins,6hrs,12hrs and 24hrs after extubation. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To estimate and compare effect of nebulisation with dexmedetomidine and ketaminedexmedetomidine on heart rate (HR), systolic blood pressure (SBP), diastolic blood
pressure (DBP)and mean arterial pressure (MAP) at defined time point. |
0 minute at induction,0 minute at intubation, 1 minute
and 5 minutes after intubation |
| To estimate and compare effect of nebulisation with dexmedetomidine and ketamine-dexmedetomidine on patient sedation using Ramsay sedation score. |
10 minutes,1hr,6hrs after extubation. |
|
|
Target Sample Size
|
Total Sample Size="80" Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/12/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Postoperative sore throat is a common complication
following general endotracheal anaesthesia affecting patient’s postoperative
comfort and satisfaction
Several pharmacological agents like Dexamethasone
Ketamine Dexmedetomidine Magnesium sulphate etc have been tried through
nebulization route have been studied with promising results Although
Dexmedetomidine nubulisation and Dexmedetomidine in combination with Ketamine
nebulisation are routinely used in Anaesthesiology practice there is literature
deficit regarding there comparison for prevention of POST This study intends to
compare efficacy of Dexmedetomidine nebulisation alone or Dexmedetomidine in
combination with Ketamine nebulisation for prevention of POST in adult patients
undergoing laparoscopic surgery
80 Patients will be randomized by computer generated
randomization number into two groups D and DK with equal number of participants
Allocation concealment will be ensured through the use of
sealed opaque envelopes
The patient and the investigator collecting the data will
be blinded to the study intervention groups
The following baseline demographic and clinical
characteristics will be recorded for all patients in preoperative area before
shifting the patient to operating room age sex ASA physical status non invasive
Blood Pressure Heart Rate SPO2 as baseline parameter Standard ASA provided
NPO guideline will be followed for the study
All patients will undergo a thorough preoperative
evaluation one day before surgery A detailed explanation of the study will be
provided to each participant and written informed consent will be obtained
Adequate fasting status will be confirmed before surgery and all patients will
receive standard anti-aspiration prophylaxis
On the day of surgery Patients will be nebulized
according to their assigned group as follows
Group D 40 Patients will be
nebulized with dexmedetomidine 1 mcg per kg diluted in 4 ml of normal saline
over 15 minutes
Group DK 40 Patients will be
nebulized with a combination of dexmedetomidine 1mcg per kg and ketamine 0.5mg
per kg diluted in 4 ml of normal saline over 15 minutes
In both groups standard anaesthesia management will be done as mentioned
below
Upon arrival in the operating room standard American Society of
Anesthesiologists ASA monitors will be attached including noninvasive blood
pressure pulse oximetry electrocardiography
The patents will be preoxygenated with 100 percentage oxygen Induction will
be achieved with intravenous fentanyl 1to2 mcg per kg and propofol 2mg
per kg titrated to the effect of loss of verbal response
and vecuronium 0.1 mg per kg and after securing airway with endotracheal
intubation anaesthesia will be maintained with Isoflurane 0.5 to 1 MAC and
O2 and N2O ratio is 40 and 60 ratio Smooth laryngoscopy and intubation lasted less
than 15 sec will be performed by same well experienced anaesthesiologist to
avoid interobserver bias
Normocapnia will be maintained with controlled mechanical ventilation with
endtidal carbondioxide tension values ranging from 30 to 35
mmHg Euvolemia will be maintained with crystalloid infusion
Normothermia will be maintained throughout the surgery with forced air warming
device and infusion of warm fluids Antiemetic in the form of Ondansetron
4mg IV will be given 30 min before end of surgery Gentle extubation of the
patient will be done after reversal of neuromuscular blocking agent after
completion of the surgery
The following parameters will be recorded in the study CormackLehane
grading during laryngoscopy ETT cuff pressure using a cuff manometer and
hemodynamic parameters systolic diastolic and mean arterial pressures heart
rate and oxygen saturation and sedation at predefined time points during
induction laryngoscopy and intubation 1 and 5minutes postintubation and
following pneumoperitoneum creation Airway pressure will be noted and keep less
than 25 cm H2O after intubation and following intraabdominal gas insufflation
The ETT intracuff pressure will be remeasured and documented just before
extubation
In the postoperative period sore throat will be assessed and graded using 4
Point scale as per Harding and McVey at 10 minutes 6 hours 12 hours
and 24 hours following extubation Sore throat will be treated according to
standard POST treatment protocol Additionally hemodynamic parameters blood
pressure heart rate and oxygen saturation will be recorded at extubation at 10
minute and 1 hour 6 hours 12 hours and 24 hours
postextubation Sedation using Ramsay sedation score will
be assessed at 15 minutes after nebulisation 10 minute 1 hour 6
hours after extubation.
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