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CTRI Number  CTRI/2024/10/075141 [Registered on: 11/10/2024] Trial Registered Prospectively
Last Modified On: 02/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Comparing Dexmedetomidine to a standard treatment to see if it helps reduce confusion in elderly undergoing urological surgeries under spinal anesthesia  
Scientific Title of Study   Effect of Intravenous Sedation with Dexmedetomidine on Postoperative Delirium in Elderly undergoing Endoscopic Urological Surgeries under Spinal Anesthesia – A Randomized Controlled Trial. 
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 Nada Fathima 
Designation  Junior Resident  
Affiliation  JIPMER 
Address  Department of Anesthesiology and Critical Care 2nd Floor IPD block JIPMER Pondicherry

Pondicherry
PONDICHERRY
605006
India 
Phone  8590554401  
Fax    
Email  nadafathima04@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Gnanasekaran S 
Designation  Associate Professor 
Affiliation  JIPMER 
Address  Department of Anesthesiology and Critical Care 2nd floor IPD block JIPMER Pondicherry

Pondicherry
PONDICHERRY
605006
India 
Phone  9487188275  
Fax    
Email  gnansdr@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Nada Fathima 
Designation  Junior Resident 
Affiliation  JIPMER 
Address  Department of Anesthesiology and Critical Care 2nd Floor IPD block JIPMER Pondicherry

Pondicherry
PONDICHERRY
605006
India 
Phone  8590554401  
Fax    
Email  nadafathima04@gmail.com  
 
Source of Monetary or Material Support  
Jawaharlal Institute of Postgraduate Medical Education & Research (JIPMER) Dhanvantri Nagar Gorimedu Pondicherry 605006 India  
 
Primary Sponsor  
Name  Dr Nada Fathima 
Address  Junior Resident Department of Anesthesiology and Critical Care Anesthesia Office 2nd Floor institute block JIPMER Pondicherry 
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 
Dr Nada Fathima  Jawaharlal Institute of Postgraduate Medical Education & Research (JIPMER)   Department of Anesthesiology and Critical Care Anesthesia Office 2nd Floor Institute block JIPMER Dhanvantri Nagar Gorimedu Pondicherry 605006
Pondicherry
PONDICHERRY 
8590554401

nadafathima04@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Interventional Studies  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: N401||Benign prostatic hyperplasia withlower urinary tract symptoms, (3) ICD-10 Condition: N20||Calculus of kidney and ureter, (4) ICD-10 Condition: C67||Malignant neoplasm of bladder,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Dexmedetomidine  Intravenous sedation with Dexmedetomidine infusion at 0.2-0.4mcg/kg/hour. Infusion will be started after ensuring adequate level of blockade (at least T10) and hemodynamic stability following spinal anesthesia. Infusion will be stopped at the end of surgery. 
Comparator Agent  Normal saline   Intravenous infusion of 0.9% normal saline. Infusion will be started after ensuring adequate level of blockade (at least T10) and hemodynamic stability following spinal anesthesia. Infusion will be stopped at the end of surgery. 
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1.Adult patients aged 60 years or older undergoing endoscopic urological surgeries under spinal anesthesia.
2.American Society of Anesthesiologists (ASA) status 1 and 2.
 
 
ExclusionCriteria 
Details  1.History of dementia or mini-cog less than 3.
2.History of psychiatric or neurodegenerative disorder
3.Profound hearing loss (difficulty in understanding loud speech)
4.Complete visual loss
5.Ischemic or valvular heart disease, heart failure (NYHA class 3 or 4), uncontrolled hypertension, severe pulmonary disease.
6.End Stage Renal Disease / Hepatic impairment.
7.Patients with failed spinal/high spinal
 
 
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 
Comparison of incidence of postoperative delirium based on Confusion Assessment Method (CAM-ICU) algorithm   Postoperative period- At 24hour  
 
Secondary Outcome  
Outcome  TimePoints 
Comparison of incidence of postoperative delirium based on Confusion Assessment Method (CAM-ICU) algorithm   48 and 72 hours in the postoperative period 
Mean Arterial Pressure (MAP) and heart rate   Intraoperative- baseline, start of infusion and every 15 minutes
Postoperative for 24 hours (every 6 hours)  
VAS score   2,6,12, and 24 hours in the postoperative period 
Catheter-induced bladder discomfort intensity by a 3point likert scale (1-comfortable, 2-uncomfortable but bearable, 3-uncomfortable and unbearable)  2,6,12, and 24 hours in the postoperative period 
Side effect profile (hypotension, bradycardia, desaturation, oversedation)   Intraoperative and postoperative
period 
Number of boluses of mephentermine administered   Intraoperative period 
Length of hospital stay in days after surgery   Date of surgery to date of discharge 
 
Target Sample Size   Total Sample Size="116"
Sample Size from India="116" 
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)   21/10/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  21/10/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
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  

INTRODUCTION

Postoperative delirium is a common complication seen during the postoperative course especially in elderly and has a deep impact on the healthcare of patients and thus on the healthcare financial management. Incidence of Postoperative Delirium (POD) is 7.8- 21.23% in endoscopic urological studies. Various studies have been demonstrated a reduced incidence of postoperative delirium with dexmedetomidine in cardiac and non-cardiac surgeries like orthopedic, abdominal and spine surgeries etc. Its impact in patients undergoing endoscopic urological surgeries is unexplored. We expect that the usage of dexmedetomidine sedation in elderly patients undergoing endoscopic urological surgeries will reduce the incidence of postoperative delirium.

METHODOLOGY

Patients satisfying the inclusion criteria will be included in the study after obtaining informed written consent. Baseline cognition status will be evaluated using the Mini-cog tool on the previous day. On arrival to the OR, standard ASA monitors [pulse oximeter, non-invasive blood pressure (NIBP), electrocardiography (ECG)] will be attached. Intravenous access will be secured, and the patient will be positioned in lateral decubitus for spinal anesthesia. Under sterile aseptic precautions, the subarachnoid blockade will be administered at L3/4 0r L4/5 with a 25-gauge Quincke needle in the lateral decubitus position. After confirmation of free flow of clear cerebrospinal fluid, 10-15mg of 0.5% hyperbaric bupivacaine will be administered intrathecally. The patient will be turned to supine position and a forced air warming blanket will be applied to the upper body to maintain normothermia. After ensuring adequate level of blockade (at least T10) and hemodynamic stability, study participants will be randomly divided into two groups: Group D and Group C. Entropy sensors will be attached to patients prior to start of drug infusion. Study participants in Group D will receive Dexmedetomidine infusion at 0.2-0.4mcg/kg/hr. and those in Group C will receive 0.9% Normal Saline infusion at the same rate. Drug infusion will be titrated to maintain entropy between 60-80. Modified observer’s assessment of alertness/sedation (OAA/S) score will noted at every 15 minutes. All patients will receive supplemental oxygen via nasal prongs (3L O2). Study drug infusion will be stopped at the end of surgery. Vital parameters including blood pressure, heart rate and oxygen saturation will be monitored at baseline (before administration of spinal), start of infusion and throughout the surgery. Side effects such as hypotension, bradycardia, desaturation and oversedation will be noted. Patients who develop hypotension (systolic blood pressure less than 20% from the baseline or less than 90 mmHg) will be treated with an intravenous 3 mg bolus dose of mephentermine and the number of boluses will be noted. When the heart rate (HR) falls to less than 45 beats/min and is associated with hypotension, atropine (0.6 mg) will be administered. The patient will be shifted to PACU and will be monitored in PACU for 2hours and then shifted to ward. Vital parameters will be monitored every 6 hours for 24 hours. The confusion assessment method (CAM-ICU) will be used to determine the occurrence of postoperative delirium at 24, 48 and 72 hours. Psychiatric consultations will be scheduled for patients who develop delirium to ensure they receive the appropriate treatment. All patients will receive intravenous paracetamol 15mg/kg q8h and pain will be assessed using VAS score at 2, 6, 12, and 24 hours. In patients with a VAS score of more than 5, a bolus of 25mg tramadol IV will be given. Catheter-induced bladder discomfort intensity will be assessed at using a 3-point scoring system (1-comfortable, 2-uncomfortable but bearable, 3-uncomfortable, and unbearable)12 at 2, 6, 12, and 24 hours and the urologist will be informed if it is grade 3. 

 



 
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