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CTRI Number  CTRI/2024/03/064189 [Registered on: 15/03/2024] Trial Registered Prospectively
Last Modified On: 16/02/2024
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 of two drugs tablet pregabalin via oral route versus intravenous dexmedetomidine as in reducing blood pressure changes in patients undergoing general anesthesia during surgeries. 
Scientific Title of Study   A comparative study on the efficacy of oral Pregabalin versus intravenous Dexmedetomidine as premedication on hemodynamic response during laryngoscopy in elective surgeries 
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 Sindhuja M 
Designation  Postgraduate resident, Department of Anesthesiology 
Affiliation  Sri venkateshwaraa medical college hospital and research centre, Ariyur, Puducherry  
Address  Department of Anesthesiology and critical care, Sri venkateshwaraa medical college hospital and research centre, Ariyur, Puducherry

Pondicherry
PONDICHERRY
605102
India 
Phone  7395891977  
Fax    
Email  sindhuja230199@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Radhakrishnan A 
Designation  PROFESSOR  
Affiliation  Sri venkateshwaraa medical college hospital and research centre, Ariyur, Puducherry  
Address  Department of Anesthesiology and critical care, Sri venkateshwaraa medical college hospital and research centre, Ariyur, Puducherry

Pondicherry
PONDICHERRY
605102
India 
Phone  8825778958  
Fax    
Email  rkpuduvai@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sindhuja M 
Designation  Postgraduate resident, Department of Anesthesiology 
Affiliation  Sri venkateshwaraa medical college hospital and research centre, Ariyur, Puducherry  
Address  Department of Anesthesiology and critical care, Sri venkateshwaraa medical college hospital and research centre, Ariyur, Puducherry

Pondicherry
PONDICHERRY
605102
India 
Phone  7395891977  
Fax    
Email  sindhuja230199@gmail.com  
 
Source of Monetary or Material Support  
Sri Venkateswaraa Medical College Hospital and Research Centre , 13-A, Pondy Villupuram Main Road, Ariyur, Puducherry 605107 
 
Primary Sponsor  
Name  Dr Radhakrishnan A professor  
Address  Department of Anaesthesiology ,Sri Venkateswaraa Medical College Hospital and Research Centre , 13-A, Pondy Villupuram Main Road, Ariyur, Puducherry 605107 
Type of Sponsor  Private medical college 
 
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 
Dr Sindhuja M  Sri Venkateshwaraa Medical College Hospital and Research Centre   Department of anesthesiology 13-A, Pondy Villupuram Main Road, Ariyur, Puducherry 605107
Pondicherry
PONDICHERRY 		 7395891977

sindhuja230199@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics committee,Sri Venkateswaraa Medical College Hospital and Research Centre,13-A, Pondy Villupuram Main Road, Ariyur, Puducherry 605107  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Intravenous dexmedetomidine 0.5 mcg/kg once  premedication before induction with general anesthesia 
Intervention  oral pregabalin 75 mg once   premedication before induction with general anesthesia 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Age groups between 18 and 65 years,  
2. American Society of Anesthesiologists physical status Class I or II
3. Elective surgeries requiring general anesthesia  
 
ExclusionCriteria 
Details  1.Patients with medical disorders like cardiovascular, renal and liver diseases
2.Patients with anticipated difficult airway  
3.Patients who are already taking pregabalin or other anticonvulsants and sedatives, beta  blockers . 
4.Patients who are not willing to participate 

 
 
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 
Mean arterial pressure, Blood pressure, Heart rate  Baseline,30 mins after oral drug , during intubation,1 min,3 min , 5 min, 10 min , every 15 min after that till 4 hours 
 
Secondary Outcome  
Outcome  TimePoints 
any adverse effects of the drug  throughout surgery 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   01/04/2024 
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="0"
Months="10"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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   This study is a randomized , double blind, parallel group , single centered trial comparing efficacy of Oral Pregabalin and intravenous Dexmedetomidine as premedication in 100 patients undergoing general anesthesia for elective surgeries that will be conducted in Sri Venkateshwaraa medical college hospital and research centre . The primary outcome measures will be change in  Mean arterial pressure, Blood pressure, Heart rate during laryngoscopy and intubation . The secondary outcomes will be incidence of any side effects intraoperatively. 
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