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CTRI Number  CTRI/2024/08/072290 [Registered on: 09/08/2024] Trial Registered Prospectively
Last Modified On: 07/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Elderly patients who undergo any major abdominal surgery under general anesthesia will be given Dexmedetomidine in two different doses or plain normal saline,and any changes in memory,recall, language etc will be compared between preoperative and postoperative states 
Scientific Title of Study   Effect of two different doses of Dexmedetomidine intraoperatively on postoperative cognitive dysfunction in elderly patients undergoing major abdominal surgery under General Anesthesia : A randomized controlled 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 Debjit Ghosh 
Designation  Junior Resident 
Affiliation  Rajendra Institute of Medical Sciences 
Address  Department of Anesthesiology, Rajendra Institute of Medical Sciences, Bariatu ,Ranchi, Jharkhand-834009

Ranchi
JHARKHAND
834009
India 
Phone  7044105727  
Fax    
Email  debjitg85@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Mukesh Kumar 
Designation  Associate Professor 
Affiliation  Rajendra Institute of Medical Sciences 
Address  Department of Anesthesiology, Rajendra Institute of Medical Sciences, Bariatu ,Ranchi, Jharkhand-834009

Ranchi
JHARKHAND
834009
India 
Phone  8709135297  
Fax    
Email  drkmukesh@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Mukesh Kumar 
Designation  Assisstant Professor 
Affiliation  Rajendra Institute of Medical Sciences 
Address  Department of Anesthesiology, Rajendra Institute of Medical Sciences, Bariatu ,Ranchi, Jharkhand-834009

Ranchi
JHARKHAND
834009
India 
Phone  7004993204  
Fax    
Email  mukeshgmch@gmail.com  
 
Source of Monetary or Material Support  
Rajendra Institute of Medical Sciences, Bariatu, Ranchi, Jharkhand, India. Pin code-834009 
 
Primary Sponsor  
Name  Rajendra Institute of Medical Sciences 
Address  Department of Anesthesiology, Rajendra Institute of Medical Sciences, Bariatu ,Ranchi, Jharkhand-834009 
Type of Sponsor  Government 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 Debjit Ghosh  Rajendra Institute of Medical Sciences  Department of Anesthesiology and General surgery operation theatre, Rajendra Institute of Medical Sciences, Bariatu , Ranchi, Jharkhand-834009
Ranchi
JHARKHAND 		 7044105727

debjitg85@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, RIMS,Ranchi  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,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Administration of 0.9% Normal Saline  After induction of anesthesia and endotracheal intubation, 0.9% Normal saline is administered intravenously as placebo agent and pre-operative and post-operative MOCA scores are compared for detailing any change in cognition 
Intervention  Infusion dose of Dexmedetomidine with a bolus dose of 1 mcg/kg intravenously followed by a maintenance dose of 0.2mcg/kg/hour  After induction of anesthesia and endotracheal intubation, Dexmedetomidine is administered via an infusion pump with a bolus dose of 1 mcg/kg body weight intravenously over 10 minutes followed by a maintenance dose of 0.2 mcg/kg/hour intravenously till the end of surgery and pre-operative and post-operative MOCA scores are compared for detailing any change in cognition 
Comparator Agent  Infusion dose of Dexmedetomidine with a bolus dose of 1.5 mcg/kg of body weight intravenously followed by a maintenance dose of 0.5 mcg/kg/hour intravenously  After induction of anesthesia and endotracheal intubation, Dexmedetomidine is administered via an infusion pump with a bolus dose of 1.5mcg/kg of body weight intravenously over 10 minutes followed by a maintenance dose of 0.5mcg/kg/hour till the end of surgery and pre-operative and post-operative MOCA scores are compared for detailing any change in cognition 
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  a. Patients belonging to ASA grade I and II.
b. Patients give informed and written consent for surgery.
c. Patients aged 60 years or more.
d.Patients undergoing elective abdominal surgeries lasting for 2 or more hours but not more than 4 hours under General Anesthesia. 
 
ExclusionCriteria 
Details  Patients belonging to ASA grade III & IV, Patients who refuse consent, Patients with pre existing diagnosis of Schizophrenia or Dementia or any condition which affects cognition, Patients with visual and hearing impairment, Patients with communication barriers who could not complete the cognition test and patients with pre operative Montreal Cognitive Assessment score less than 26. 
 
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 
To determine whether the use of intraoperative Dexmedetomidine is associated with a decreased incidence of post-operative cognitive dysfunction in elderly patients  MOCA scale will be used to assess patients cognition status before surgery
and
1 hour after surgery
6 hours after surgery
24 hours after surgery and preoperative and postoperative cognition scores will be compared 
 
Secondary Outcome  
Outcome  TimePoints 
To determine at which dose Dexmedetomidine has a more favourable effect on postoperative cognitive dysfunction and whether Dexmedetomidine plays a role in post operative analgesia.  For 1 hour,6 hours, and 24 hours after end of general anesthesia. 
 
Target Sample Size   Total Sample Size="72"
Sample Size from India="72" 
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   Phase 4 
Date of First Enrollment (India)   18/08/2024 
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="1"
Months="0"
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   Post operative cognitive dysfunction is defined as a new cognitive impairment arising after a surgical procedure. Its diagnosis requires both pre- and post-operative psychrometric testing. The most commonly seen problems are memory impairment and impaired performance on intellectual tasks.
Approximately 25% of all elderly patients having major surgery will have an identifiable fall in cognition and 50%of these patients will suffer a permanent dysfunction.
Dexmedetomidine is a specific and selective alpha-2 adrenoceptor agonist. By binding to presynaptic alpha-2 adrenoceptors, it inhibits the release of norepinephrine, therefore terminating the propagation of pain signals. It also has sympatholytic and sedative effects on the human body.
The MOCA(Montreal Cognitive Assessment scale) was designed as a rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains like attention and concentration, executive functions, memory, language, visuo-constructional skills, conceptual thinking, calculation and orientation etc. The total possible score is 30 points, with 26 or above considered as a normal score.

In this study we compare two different doses of Dexmedetomidine based on their effectivity in decreasing the incidence of post operative cognitive dysfunction in elderly patients undergoing major abdominal surgery under general anesthesia.
 
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