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CTRI Number  CTRI/2012/06/002746 [Registered on: 26/06/2012] Trial Registered Retrospectively
Last Modified On: 06/10/2013
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   The use of intravenous dexmedetomidine as an additional drug to epidural morphine in providing adequate pain relief and sedation in patients undergoing major operations like thoracotomy. 
Scientific Title of Study   Effect of intravenous dexmedetomidine as an adjuvant to epidural morphine on the perioperative analgesic requirement in patients undergoing thoracotomy  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
IESC/T-104/04.03.2011  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  RAVINDRAN CHANDRAN 
Designation  JUNIOR RESIDENT 
Affiliation  ALL INDIA INSTITUTE OF MEDICAL SCIENCES 
Address  DEPARTMENT OF ANESTHESIOLOGY AND INTENSIVE CARE, AIIMS, NEW DELHI-110029
ALL INDIA INSTITUTE OF MEDICAL SCIENCES (AIIMS), NEW DELHI-110029
South
DELHI
110029
India 
Phone  7838288091  
Fax    
Email  ravindranchandiran@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  LOKESH KASHYAP 
Designation  PROFESSOR 
Affiliation  AIIMS 
Address  DEPARTMENT OF ANAESTHESIOLOGY AND INTENSIVE CARE, AIIMS, NEW DELHI-110029
DEPARTMENT OF ANAESTHESIOLOGY AND INTENSIVE CARE, AIIMS, NEW DELHI-110029
South
DELHI
110029
India 
Phone  9868397821  
Fax    
Email  lokeshkashyap@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  LOKESH KASHYAP 
Designation  PROFESSOR 
Affiliation  AIIMS 
Address  DEPARTMENT OF ANAESTHESIOLOGY AND INTENSIVE CARE, AIIMS, NEW DELHI-110029
DEPARTMENT OF ANAESTHESIOLOGY AND INTENSIVE CARE, AIIMS, NEW DELHI-110029
South
DELHI
110029
India 
Phone  9868397821  
Fax    
Email  lokeshkashyap@yahoo.com  
 
Source of Monetary or Material Support  
AIIMS 
 
Primary Sponsor  
Name  ALL INDIA INSTITUTE OF MEDICAL SCIENCES 
Address  DEPARTMENT OF ANAESTHESIOLOGY AND INTENSIVE CARE, ROOM NO-5011, AIIMS, NEW DELHI-110029  
Type of Sponsor  Research institution and hospital 
 
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 
LOKESH KASHYAP  AIIMS  ALL INDIA INSTITUTE OF MEDICAL SCIENCSE, NEW DELHI-110029
South
DELHI 
9868397821

lokeshkashyap@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
OFFICE OF ETHICS SUB COMMITTEE, ALL INDIA INSTITUTE OF MEDICAL SCIENCES  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  carcinoma lung patients undregoing thoracotomy,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Dexmedetomidine  Initial bolus - 1 microg/kg over 10 min, followed by 0.4 microg/kg/hr infusion till end of surgery.  
Comparator Agent  normal saline  Initial bolus of 1 ml/kg/min over 10 mins followed by 0.4 ml/kg/min infusion till the end of surgery 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  ELECTIVE THORACOTOMY 
 
ExclusionCriteria 
Details  • patients refusal to participate
• patients who have psychiatric disturbances
• severe chest wall/spinal deformity
• patients with coagulation disorders/pts on anticoagulants
• severe ventricular dysfunction
• patients in shock
• liver disease patients
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To study the effect of intravenous dexmedetomidine as an adjuvant to epidural morphine on perioperative analgesic requirement in patients undergoing thoracotomy.


 
Amount of intravenous morphine used intaraoperatively in each groups 
 
Secondary Outcome  
Outcome  TimePoints 
Postoperative analgesia requirement  Total amount of PCA morphine used at the end of 24 hrs in postoperative period 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   N/A 
Date of First Enrollment (India)   14/03/2011 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Post thorocotomy pain delays recovery and increases the postoperative morbidity. The anguish caused by thoracotomy is gruelling to patients with toilsome postoperative pain. The incision in thoracotomy is extremely painful as it involves resection of rib and muscle cutting incisions. Therefore pain following thoracotomy is of serious concern. The acute incissional pain in thorocotomy impedes the chest wall expansion and cough reflex leading on to accumulation of secretions, ventilation perfusion mismatch, atelectasis , hypoxia , infection thereby delaying the recovery. 

 

                            Thoracic epidural analgesia is a common modality for providing pain relief in patients undergoing thoracotomy. Other methods of analgesia used as a part of multimodal analgesia regimen are intravenous, intrathecal or epidural narcotics, NSAIDS, lumbar epidural block, paravertebral block,  intercostal nerve block, intrapleural analgesia , cryoanalgesia, and transcutaneous nerve stimulation. Multimodal analgesia techniques along with multidisciplinary rehabilitation program may enhance postoperative recovery, decrease the duration of hospital stay, and facilitate early convalescence. Multimodal analgesia provides superior dynamic pain relief with reduced analgesic-related side effects.  Many researchers have found that the use of adjuvants like fentanyl, morphine , clonidine , ketamine, ketorolac  with epidural local anaesthetics increases the efficacy of epidural analgesia and decreases the side effects .

 

                        

                            Clonidine and dexmedetomidine are two α2-agonists used as an intravenous anaesthetics. Dexmedetomidine is eight times more α2 selective  than clonidine .Dexmedetomidine has been recommended for use as a sedative in patients on mechanical ventilation in Intensive care unit. The use of intravenous dexmedetomidine for has been found to reduce the requirement of opioid analgesia and also improve hemodynamic stability. It provides anxiolysis and sedation without respiratory depression.  Patients are sedated but arousable following use of dexmedetomidine. It also provides haemodynamic stability and attenuates the increases in heart rate and stress response during intubation and emergence of anesthesia. It reduces stress response to surgery and provide perioperative cardio protection in patients having coronary risk factors. Recently dexmedetomidine due to these various advantages is used as an adjuvant analgesic in various vascular, bariatric and thoracic surgeries. Other routes like epidural dexmedetomidine also have been tried by few researchers. They have found that the use of dexmedetomidine through epidural route  also reduces the postoperative morphine requirement 19.

 

                        This prospective, randomized study has been designed to find out the efficacy of intravenous dexmedetomidine to provide adjuvant analgesia along with epidural morphine in 0.1% bupivacaine in decreasing the perioperative analgesic requirement and awareness in patients undergoing thorocotomy 
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