FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2020/06/026077 [Registered on: 23/06/2020] Trial Registered Prospectively
Last Modified On: 14/08/2021
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   Effect of drug given during spine surgery for old aged patients on Recovery and mentation 
Scientific Title of Study   Effect of Intraoperative Dexmedetomidine infusion on Postopearative Cognitive Dysfunction and Recovery Quality in an Elderly Patient posted for Spine Surgery: a Randomized Prospective Double Blinded 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 Inderpreet Singh Walia 
Designation  DNB Resident Neuroanaesthesia 
Affiliation  Indraprastha Apollo Hospital  
Address  Anaesthesia Office , OT Complex 1 , First Floor

South
DELHI
110076
India 
Phone    
Fax    
Email  inderpreet.inderwalia@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr K J Choudhury 
Designation  Senior Consultant  
Affiliation  Indraprastha Apollo Hospital  
Address  Anaesthesia Office , OT Complex 1 , First Floor

South
DELHI
110076
India 
Phone    
Fax    
Email  kjchoudhury@samvedana.org  
 
Details of Contact Person
Public Query
 
Name  Dr K J Choudhury 
Designation  Senior Consultant  
Affiliation  Indraprastha Apollo Hospital  
Address  Anaesthesia Office , OT Complex 1 , First Floor

South
DELHI
110076
India 
Phone    
Fax    
Email  kjchoudhury@samvedana.org  
 
Source of Monetary or Material Support  
Indraprastha Apollo Hospital New Delhi 
 
Primary Sponsor  
Name  Indraprastha Apollo Hospital New Delhi  
Address  Sarita Vihar New Delhi 110076 
Type of Sponsor  Private hospital/clinic 
 
Details of Secondary Sponsor  
Name  Address 
nil   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
inderpreet singh walia  Indraprastha Apollo Hospital  Ot Complex 1 ,First Floor , Indraprastha Apollo Hospital
South
DELHI 
9876624523

inderpreet.inderwalia@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Indraprastha Apollo Hospital Institutional Ethics Committee  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 
Intervention  Dexmedetomidine  dose - 0.5mcg/kg intravenous bolus , followed by 0.5mcg/kg/hour till the start of skin closure 
Comparator Agent  placebo   equal dose as compared to dexmedetomidine group intravenously 
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Patients with American Society of Anesthesiologists (ASA) physical status I-III aged 60- 80 years old, undergoing elective lumbar spine surgery  
 
ExclusionCriteria 
Details  1. Patients age less than 60 years and more than 80 years old.
2. Patients with a pre-operative or intraoperative ECG (electrocardiogram) that showed severe bradycardia (sinus rhythm, heart rate less than 50/ min) or conduction block
3. Patients with associated renal, hepatic and respiratory dysfunction.
4. Patients with history of central nervous system disease such as head injury, stroke, previous neurosurgery, behavioral disturbances or mental retardation.
5. Patients with preoperative cognitive dysfunction (MMSE<24)
6. Patients on β-blockers, cimetidine, digoxin, α2-agonists, anticonvulsants or psychotropic medications
7. Patients with allergy to dexmedetomidine or another alpha-2 adrenergic receptor agonist
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Other 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Mini- Mental State Examination (MMSE) Scores.
2. 15-item quality of recovery score (QoR15) questionnaire.

 
1. Before Anaesthesia
2. Day 1 of Surgery
3. Day 2 of Surgery
4. Day 3 of Surgery

 
 
Secondary Outcome  
Outcome  TimePoints 
1. Intraoperative propofol consumption.
2. Intraoperative and postoperative fentanyl requirement.
3. Haemodynamic changes
 
till the duration of surgery 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   N/A 
Date of First Enrollment (India)   24/06/2020 
Date of Study Completion (India) 14/08/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 14/08/2021 
Estimated Duration of Trial   Years="0"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
yet to get published 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  
This study is aimed to see the ’’ Effect of Intraoperative Dexmedetomidine infusion on Postopearative Cognitive Dysfunction and Recovery Quality in an Elderly Patient posted for Spine Surgery’’ 

Primary Outcome Variables:

We will assess postoperative cognitive function and quality of recovery utilizing

1.    1.  Mini- Mental State Examination (MMSE) Scores.

2.     2.  15-item quality of recovery score (QoR15) questionnaire.

 Secondary Outcome Variables:

1.     Intraoperative propofol consumption.

2.     Intraoperative and postoperative fentanyl requirement.

3.     Haemodynamic changes.

On the day of surgery, a baseline neurophysiological testing, using both MMSE (T0) and QoR15 (Q0) scoring would be done at 7:00 am. No sedative premedication will be prescribed. After adequate fasting, the patient will be shifted to the operating theatre where monitors such as electrocardiogram, pulse oximeter, and non-invasive blood pressure cuff will be applied and intravenous (IV) access secured. At this time computer generated randomization table will be used to assign each patient to either the dexmedetomidine group (Group D, n=30) or placebo group (Group P, n=30). A 50 ml syringe containing dexmedetomidine 4mcg/ml in normal saline for Group D or normal saline for Group P will be prepared shortly before induction anaesthesia by an anesthesiologist, who will be the part of study but not involved in the perioperative management of these patients. The study drug infusion will be started by the same anesthesiologist soon after the securing the IV access. Group D will receive IV dexmedetomidine at the rate of 0.5 mcg/kg/hr until beginning of skin closure. Group P will receive volume matched saline.

 

 
Close