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CTRI Number  CTRI/2013/06/003755 [Registered on: 14/06/2013] Trial Registered Prospectively
Last Modified On: 19/04/2013
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To compare the effect of Fentanyl and Dexmedetomidine when added to bupivacaine in Spinal Anaesthesia  
Scientific Title of Study   EFFECT OF ADDING DEXMEDETOMIDINE VERSUS FENTANYL TO INTRATHECAL BUPIVACAINE ON SPINAL BLOCK CHARACTERISTICS IN GYNAECOLOGICAL PROCEDURES: A DOUBLE BLIND CONTROLLED STUDY 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
U1111-1138-3349  UTN 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr NIKHIL NANDAN 
Designation  JUNIOR RESIDENT 
Affiliation  Govt Medical College, Trivandrum 
Address  DR.NIKHIL NANDAN JUNIOR RESIDENT DEPARTMENT OF ANAESTHESIOLOGY GOVT. MEDICAL COLLEGE, TRIVANDRUM

Thiruvananthapuram
KERALA
695011
India 
Phone    
Fax    
Email  nikhilnandan@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr LINETTE J MORRIS 
Designation  PROFESSOR 
Affiliation   
Address  DR. LINETTE J. MORRIS PROFESSOR OF ANAESTHESIA DEPARTMENT OF ANAESTHESIOLOGY GOVT. MEDICAL COLLEGE, TRIVANDRUM

Thiruvananthapuram
KERALA
695011
India 
Phone    
Fax    
Email  linettemorris5@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr NIKHIL NANDAN 
Designation  JUNIOR RESIDENT 
Affiliation  Govt Medical College, Trivandrum 
Address  DR.NIKHIL NANDAN JUNIOR RESIDENT DEPARTMENT OF ANAESTHESIOLOGY GOVT. MEDICAL COLLEGE, TRIVANDRUM

Thiruvananthapuram
KERALA
695011
India 
Phone    
Fax    
Email  nikhilnandan@gmail.com  
 
Source of Monetary or Material Support  
Govt Medical College Trivandrum 
 
Primary Sponsor  
Name  Govt Medical College Trivandrum 
Address  GOVERNMENT MEDICAL COLLEGE MEDICAL COLLEGE P.O PIN - 695011 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
Dr Nikhil Nandan  Junior Resident Department of Anaesthesiology Govt. Medical College Trivandrum 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Nikhil Nandan  obstetric and gynaecology OT including pre and postoperative care room  Department of Anaesthesiology Sree Avittam Thirunal Hospital Govt. Medical College Trivandrum
Thiruvananthapuram
KERALA 
9895415212

nikhilnandan@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Human Ethics Commitee Medical College Trivandrum  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Elective Gynaecological Surgeries,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Bupivacaine with Dexmedetomidine  Dose -2cc 0.5%(Heavy) bupivacaine (10mg ) + 5µg Dexmedetomidine in 0.5 cc preservative free solution Frequency -single shot Route -Intrathecal 
Comparator Agent  Bupivacaine with Fentanyl  Dose - 2cc 0.5%(Heavy) bupivacaine (10mg ) + 25µg fentanyl in 0.5 cc of preservative free solution. Frequency - single shot Route-Intrathecal 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  80.00 Year(s)
Gender  Female 
Details  ASA I / II / III of ASA physical status classification.

Height 155 to 175 cm
 
 
ExclusionCriteria 
Details  Patients having drug allergy to local anaesthetics.
Those with anatomical abnormalities of the spine, peripheral neuropathy, bleeding disorders or anticoagulation therapy.
Patients with serious systemic illness, psychiatric illness, mental retardation.
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
Duration of analgesia in terms of time for onset of mild pain postoperatively visual analogue scale 4 and above or patient request for analgesia  Visual analogue scale assessed every 15 minutes till score reaches 4 and above or till the patient requests analgesia 
 
Secondary Outcome  
Outcome  TimePoints 
Time for onset of adequate level of analgesia ( T10 level assessed by bilateral pin prick )  Intraoperative 
Peak sensory level reached   Intraoperative 
Time taken for motor block to recede to Bromage   Intraoperative and Postoperative 
Sedation produced by the two groups   Intraoperative every 15 minutes 
Haemodynamic profile of the two groups  every minute for the first 20 minutes and every two-minute for the next 20 minutes and every five minutes till the end of surgery and then every 10-15 minutes for three hours post operatively 
Need of additional analgesic  Intraoperative 
• Incidence of complications including depression, nausea, vomiting, pruritus, hypotension, bradycardia, shivering between the two groups  Intraoperative and Postoperative 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   01/07/2013 
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   Non yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Dexmeditomedine is an α-2 adreno receptor agonist, which is approved as an intravenous sedative and analgesic drug. It is a useful adjuvant in regional anesthesia. Kanazi et al, found that 5μg Dexmeditomedine and 50μg clonidine are equipotent intrathecally when added to Bupivacaine in patients undergoing major surgeries in the abdomen and lower extremities. Dexmeditomedine given intrathecally along with Bupivacaine produce significantly longer duration of sensory and motor block than Bupivacaine alone without serious side effects. It maintains patient arousability and respiratory function. Dexmeditomedine has a role in the field of critical care and it also facilitates easy weaning from mechanical ventilation.

 

Fentanyl is a potent, synthetic narcotic analgesic with a rapid onset and short duration of action. It is a strong agonist at the μ-opioid receptors. Historically it has been used to treat breakthrough pain and is commonly used in pre-procedures as a pain reliever as well as an anaesthetic in combination with a benzodiazepine. Fentanyl is approximately 100 times more potent than morphine, with 100 micrograms of fentanyl approximately equivalent to 10 mg of morphine and 75 mg of pethidine (meperidine) in analgesic activity.It has an LD50 of 3.1 milligrams per kilogram in rats, and an LD50 of 0.03 milligrams per kilogram in monkeys.

Gynaecological procedures including vaginal hysterectomy, recanalization, ovarian cystectomy  are often done under regional anesthesia. Surgery on the uterus and other genital organs performed under epidural or spinal block is often accompanied by visceral pain, nausea and vomiting. Fentanyl in various doses (10, 20, 30, 40 μg) when added to spinal Bupivacaine increase the duration of analgesia and reduce intraoperative nausea and vomiting. Dexmedetomidine is an α2- adrenoreceptor agonist that is approved as an intravenous sedative and coanalgesic drug. Its use is often associated a decrease in heart rate and blood pressure. Intrathecal and epidural characteristics of Dexmedetomidine were studied in animals. Most of the clinical studies about intrathecal α2 adrenoreceptor agonist are related to clonidine. There is little in the literature about the use of intrathecal Dexmedetomidine with local anaesthesia in humans. Kanazi et al.found that 3 μg Dexmedetomidine and 30 μg clonidine are equipotent intrathecally when added to bupivacaine in patients undergoing urology procedures. The same author found that Dexmedetomidine and Clonidine produced significant short onset of sensory and motor block as well as significantly longer duration of sensory and motor block than Bupivacaine alone without serious side effects. The aim of this study is to compare the effect of Dexmedetomidine 5μg versus fentanyl 25 μg on intraoperative analgesia and the duration of sensory motor block when added to 10 mg intrathecal plain bupvacaine.

 
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