FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2021/07/035181 [Registered on: 27/07/2021] Trial Registered Prospectively
Last Modified On: 24/03/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia
Dentistry 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Comparison Between DEXMEDETOMIDINE nasal Spray AND NORMAL SALINE nasal Spray In Patients Undergoing Removal of teeth by surgical method For anxiety reduction  
Scientific Title of Study   “Comparative evaluation of intranasal DEXMEDETOMIDINE spray versus intranasal NORMAL SALINE spray in patients undergoing transalveolar extractions for anxiety reduction – A RANDOMISED CONTROL STUDY” 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Mrudula Ravindra Mulay 
Designation  2nd year MDS 
Affiliation  Sumandeep Vidyapeeth 
Address  room no 2 department of oral and maxillofacial surgery KMSDCH sumandeep vidyapeeth

Vadodara
GUJARAT
391760
India 
Phone  7588141570  
Fax    
Email  mulaymrudula@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Amit Mahajan  
Designation  Professor and PG guide  
Affiliation  Sumandeep Vidyapeeth 
Address  room no 2 department of oral and maxillofacial surgery KMSDCH sumandeep vidyapeeth

Vadodara
GUJARAT
391760
India 
Phone  7588141570  
Fax    
Email  dramitmds@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Mrudula Ravindra Mulay 
Designation  2nd year MDS 
Affiliation  Sumandeep Vidyapeeth 
Address  Room no 2 Department of Oral and Maxillofacial Surgery KMSDCH sumandeep vidyapeeth

Vadodara
GUJARAT
391760
India 
Phone  7588141570  
Fax    
Email  mulaymrudula@gmail.com  
 
Source of Monetary or Material Support  
K M Shah Dental College and Hospital  
 
Primary Sponsor  
Name  DrMrudulaRavindra Mulay Self 
Address  room no. 2 department of Oral and maxillofacial surgery KMSDCH sumandeep vidyapeeth 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrMrudula Ravindra Mulay  K. M. Shah Dental College and Hospital  room no. 2 department of oral and maxillofacial suregry KMSDCH sumandeep vidyapeeth
Vadodara
GUJARAT 		 7588141570

mulaymrudula@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sumandeep Vidyapeeth Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K011||Impacted teeth,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  dexmedetomidine  1.5mcg/kg Dose intranasal spray Route -Nasal 
Comparator Agent  Normal saline  1.5mcg/kg Dose intranasal spray Route - Nasal  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. The participants with carious tooth / impacted tooth which needs to be removed by transalveolar method.
2. Participants above age group of 18 and below the age of 60.
3. Participants of both the genders will be included.
4. Participant who are physically and medically fit for the surgery.
5. Patients undergoing transalveolar extractions and willing to participate in the study (with informed consent)
 
 
ExclusionCriteria 
Details  1. Medically compromised patients with extremes of ages.
2. Patients not willing for the study
3. Patients with allergic rhinitis, breathing disorders and running nose.
4. Patients allergic to dexmedetomidine
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
This study will enable us to whether intranasal dexmedetomidine spray will provide better anxiety control and sedation or not in patients undergoing transalveolar extractions under local anesthesia with adrenaline.

 
Baseline
(15min before surgery) 0 Minutes
(Immediately After spray) 15 Minutes
(Immediately After Injecting LA)
30 Minutes 45 Minutes

 
 
Secondary Outcome  
Outcome  TimePoints 
evaluate and compare the anxiety level, sedation status of the patient following intranasal dexmedetomidine spray and intranasal saline spray as a placebo effect during transalveolar extractions.  Baseline
(15min before surgery) 0 Minutes
(Immediately After spray) 15 Minutes
(Immediately After Injecting LA)
30 Minutes 45 Minutes

 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   02/08/2021 
Date of Study Completion (India) 06/01/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   The Transalveolar extractions are  one of the most common procedures performed in the field of oral and maxillofacial surgery. Dexmedetomidine is an alpha 2 - adrenoceptor agonist with dose-dependent alpha 2 adrenoceptor selectivity. It is a useful sedative agent that possesses analgesic properties, hemodynamic stability.Intranasal sedation is a non-invasive way of drug administration, which is safe and is well tolerated by children as well as adults . It also saves the fearful patient from receiving more injections.Pre-operative anxiety and discomfort are inevitable consequences in absence of preoperative sedation in patient undergoing transalveolar extractions. An ideal pre-medication allays apprehension in minds of patients and achieves a calm, sedated patient for smooth induction of anesthesia, hassle free transalveolar extractions  and rapid recovery in post-operative period.This study has been planned and will be conducted to find out the additional effectiveness and anxiety control  if any of dexmedetomidine nasal spray in transalveolar extractions of adult patients This information can be used to modify the Protocols as required.objectives are to evaluate and compare the anxiety level, sedation status and pain experience of the patient following intranasal dexmedetomidine spray and intranasal saline spray as a placebo effect during transalveolar extractions.and To evaluate and compare blood pressure, oxygen saturation and pulse rate following intranasal dexmedetomidine spray and intranasal saline spray as a placebo effect during transalveolar extractions.Patients under the study received  1.5mcg/kg of dexmedetomidine by intranasal spray prior to local anaesthesia for A group and intranasal normal saline spray for group B as control group as placebo effect.Double  blinding will be done at the level of the patient and principal investigator . He/ She will not be knowing which group they belong for achieving placebo effect. Follow Standard procedure for transalveolar extractions.During the procedure the oxygen saturation levels, pulse rate, blood pressure, of the patient was recorded immediately after the injection of local anesthesia and every 15 minutes from then till the end of the procedure.The sedation score was assessed using Ramsay’s Sedation Scale by the operating surgeon every 15 minutes after local anesthesia was given Pain experience was recorded with the help of the visual analogue scale every 15 minutes after injection of local anesthesia. The values were then tabulated and results were derived.

 

 
Close