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CTRI Number  CTRI/2018/01/011178 [Registered on: 08/01/2018] Trial Registered Prospectively
Last Modified On: 24/12/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Efficacy of morphine and dexmedetomidine as adjuvants to levobupivacaine in spinal anaesthesia for abdominal hysterectomy 
Scientific Title of Study   Comparison of morphine and dexmedetomidine as adjuvants to isobaric levobupivacaine for spinal anaesthesia in patients undergoing abdominal hysterectomy 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Mayank Kumar 
Designation  Assistant Professor 
Affiliation  AIIMS Raipur 
Address  Faculty Room No. 03, A Block AIIMS Raipur
G. E. Road AIIMS Raipur
Raipur
CHHATTISGARH
492099
India 
Phone  9971760416  
Fax    
Email  mayanksonupmch@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Mayank Kumar 
Designation  Assistant Professor 
Affiliation  AIIMS Raipur 
Address  Faculty Room No. 03, A Block AIIMS Raipur
G. E. Road AIIMS Raipur
Raipur
CHHATTISGARH
492099
India 
Phone  9971760416  
Fax    
Email  mayanksonupmch@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Mayank Kumar 
Designation  Assistant Professor 
Affiliation  AIIMS Raipur 
Address  Faculty Room No. 03, A Block AIIMS Raipur
G. E. Road AIIMS Raipur
Raipur
CHHATTISGARH
492099
India 
Phone  9971760416  
Fax    
Email  mayanksonupmch@gmail.com  
 
Source of Monetary or Material Support  
AIIMS Raipur 
 
Primary Sponsor  
Name  AIIMS Raipur 
Address  G.E. Road Raipur 
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 
Dr Mayank Kumar  O. T. Complex, Department of Anaesthesiology, AIIMS Raipur  G.E. Road Raipur
Raipur
CHHATTISGARH 
9971760416

mayanksonupmch@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC AIIMS Raipur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  All participant will either be ASA ( American Society of Anaesthesiologist ) grade 1 or 2,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Dexmedetomidine  It is a highly selective α2 adrenergic receptor agonist, now emerging as an adjuvant to regional anaesthesia, where evolving studies can build evidence for its safe use in central neuraxial blocks. 
Comparator Agent  Morphine  It is widely used spinal anaesthesia for post-operative analgesia because of its prolonged post-operative analgesic effects 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Female 
Details  1. ASA 1 or 2 patients
2. 18 - 60 yrs of age
3. Patient undergoing abdominal hysterectomy under subarachnoid block  
 
ExclusionCriteria 
Details  a) Patients with contraindications for spinal anaesthesia
b) ASA grade III and above
c) Known allergy to any of the study medications
d) Acute or chronic respiratory disease
e) Hypertension or other cardiovascular abnormalities
f) Cognitive or psychiatric disturbances
g) Patients taking α adrenergic receptor antagonist, ACE inhibitors, angiotensin receptor blockers, chronic opioid therapy
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
we will compare analgesic efficacy of two drugs which are used for control of pain for hysterectomy  intraoperative and postoperative upto 24 hrs 
 
Secondary Outcome  
Outcome  TimePoints 
Adverse effects
Vital parameters 
Intraoperative and postoperative upto 24 hrs 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
Final Enrollment numbers achieved (Total)= "70"
Final Enrollment numbers achieved (India)="70" 
Phase of Trial   Post Marketing Surveillance 
Date of First Enrollment (India)   12/01/2018 
Date of Study Completion (India) 24/08/2020 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   none yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Morphine  is widely used an adjuvant to regional anaesthesia for post-operative analgesia because of its prolonged post-operative analgesic effects. It is associated with side effects like nausea, vomiting, pruritus, urinary retention and- most feared - respiratory depression.

Dexmedetomidine now emerging as an adjuvant to regional anaesthesia, Intrathecal dexmedetomidine when combined with local anesthetic prolongs the sensory block by depressing the release of C-fibre transmitters and by hyperpolarization of postsynaptic dorsal horn neurons. Motor block prolongation by α2 adrenergic agonist may result from binding of α2 agonists to motor neurons in the dorsal horn of the spinal cord.

The primary aim of the study is to compare analgesic efficacy of these two adjuvants simultaneously observing the adverse effects, characteristics of spinal block and perioperative vital parameters.

 Seventy patients between 18 to 60 years of age, posted for abdominal hysterectomy under subarachnoid block with isobaric 0.5% levobupivacaine, will be recruited.

Intervention and Study Groups

Patients will be randomly allocated to two groups (group M & group D) of 35 each by computer generated list. Group M will receive 3 ml of 0.5% isobaric levobupivacaine with morphine & Group D will receive 3 mL of 0.5% isobaric levobupivacaine with dexmedetomidine. After performing spinal block, the vital signs will be recorded every 5 min for the first  30 min, every 15 min for the next hour and thereafter, half hourly till the request for supplemental analgesia

Implication of the Study

Dexmedetomidine may be having equal or even better analgesia with better side effect profile in comparison to morphine and hence may become adjuvant drug of choice for various abdominal surgeries done under spinal anaesthesia.

 
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