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CTRI Number  CTRI/2025/01/079635 [Registered on: 28/01/2025] Trial Registered Prospectively
Last Modified On: 27/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Effects of two different doses of dexmedetomidine infusion on haemodynamic stress response, sedation and postoperative analgesia requirement in patients undergoing laparoscopic cholecystectomy. 
Scientific Title of Study   A randomised clinical trial on the effects of two different doses of dexmedetomidine infusion on haemodynamic stress response, sedation and postoperative analgesia requirement in patients undergoing laparoscopic cholecystectomy. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sukanta Saha 
Designation  Post Graduate Trainee 
Affiliation  Regional Institute of Medical Sciences Imphal 
Address  Department of Anaesthesiology Regional Institute of Medical Sciences Imphal Imphal West MANIPUR 795004 INDIA

Imphal West
MANIPUR
795004
India 
Phone  7085896662  
Fax    
Email  sukantasahabanik@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  N Anita Devi 
Designation  Professor 
Affiliation  Regional Institute of Medical Sciences Imphal 
Address  Department of Anaesthesiology Regional Institute of Medical Sciences Imphal Imphal West MANIPUR 795004 INDIA

Imphal West
MANIPUR
795004
India 
Phone  8787458045  
Fax    
Email  dranitadevin@gmail.com  
 
Details of Contact Person
Public Query  
Name  N Anita Devi 
Designation  Professor 
Affiliation  Regional Institute of Medical Sciences Imphal 
Address  Department of Anaesthesiology Regional Institute of Medical Sciences Imphal Imphal West MANIPUR 795004 INDIA


MANIPUR
795004
India 
Phone  8787458045  
Fax    
Email  dranitadevin@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology Regional Institute of Medical Sciences Imphal Manipur Imphal West India Pin 795004 
 
Primary Sponsor  
Name  Sukanta Saha 
Address  Regional Institute of Medical Sciences Imphal Manipur Imphal West India Pin 795004 
Type of Sponsor  Other [Post Graduate Trainee] 
 
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 Sukanta Saha  Regional Institute of Medical Sciences Imphal Manipur   Elective Surgery Operation theatre complex (OT 3 and OT 4) Department of Anaesthesiology Regional Institute of Medical Sciences Imphal Imphal West Manipur
Imphal West
MANIPUR 		 7085896662

sukantasahabanik@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Research Ethics Board Regional Institute of Medical Sciences Imphal Manipur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: O||Medical and Surgical, (3) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Dexmedetomidine 0.2 mcg/kg/h  Study participants will be randomized into two groups. Intervention group receiving dexmedetomidine 0.2 mcg/kg/h infusion 15 minutes before induction of anaesthesia and continue till surgical procedure finish. 
Comparator Agent  Dexmedetomidine 0.4 mcg/kg/h  Study participants will be randomized into two groups. Intervention group receiving dexmedetomidine 0.4 mcg/kg/h infusion 15 minutes before induction of anaesthesia and continue till surgical procedure finish. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Patient of age group 18-65 yrs.
2. Patient with American society of Anesthesiologists (ASA) physical grade I or II. 
 
ExclusionCriteria 
Details  1. Patient who refused to give consent.
2. Local site infection.
3. History of allergy to study drugs specially amide group of drugs.
4. patient taking any analgesic and anticoagulant (bleeding tendencies).
5. uncontrolled cardiovascular, central nervous system, respiratory system comorbidities and kidney disorders.
6. Psychiatric patients.
7. Anticipated difficult intubation. 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Haemodynamic changes (hypertension, bradycardia) and sedation effect.  Haemodynamic changes (hypertension, bradycardia), sedation effect and sedation score (15 min, 30 min, 45 min, 60 min, 120 min). 
 
Secondary Outcome  
Outcome  TimePoints 
Post-operative analgesia requirements.  We will observe total analgesic requirement on patient demand in 24 hours post-operative period. 
 
Target Sample Size   Total Sample Size="64"
Sample Size from India="64" 
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)   10/02/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  10/02/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
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  
The study will be conducted on “A randomised clinical trial on the effects of two different doses of dexmedetomidine infusion on haemodynamic stress response, sedation and post-operative analgesia requirement in patients undergoing laparoscopic cholecystectomy”. Here, in our study we will compare the infusion of two low doses of dexmedetomidine with an aim to assess the effect on haemodynamic stress response, sedation during the surgical procedure. We will also try to find out the post-operative analgesia requirement. A total of 64, aged 18 to 65 years belonging to American society of Anaesthesiologists (ASA) I and II, undergoing laparoscopic cholecystectomy under general anaesthesia will be divided into two groups (Group A, group B) by block randomization. Group A patients will receive dexmedetomidine 0.2 mcg/kg/h as intravenous infusion, group B patients will receive dexmedetomidine 0.4 mcg/kg/h as intravenous infusion. Hemodynamic parameters will be monitored and recorded during before starting the infusion, 15 min after starting the infusion, after induction, after intubation, after creation and release of pneumoperitoneum and after extubation. Patients were also observed for time to extubate trachea, post-operative sedation level, time to first rescue analgesic requirement, total amount of analgesic drug required during the first 24 h post-operatively and the adverse effects. The findings and observations made during the entire study will be tabulated, graphically depicted whenever possible, statistically analyzed and inference will be drawn.

 
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