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
|
|
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
|
|
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
|
|
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 |