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CTRI Number  CTRI/2024/03/063906 [Registered on: 11/03/2024] Trial Registered Prospectively
Last Modified On: 08/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical trail to study the effect of intrathecal Dexmeditomidine with Magnesium sulphate as an additional adjuvant to intrathecal Morphine and Bupivacaine combination for post operative analgesia in patients undergoing major abdominal surgeries. 
Scientific Title of Study   Comparison of Dexmedetomidine with Magnesium sulphate as an additional adjuvant to intrathecal Bupivacaine and Morphine combination for post operative analgesia in patients undergoing major abdominal Surgeries. A Prospective randomized double blind study. 
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. Janaki subhdra peyyety 
Designation  Professor , Department of Anaesthesiology , SVIMS 
Affiliation  Sri venkateswara institute of Medical sciences 
Address  Department of Anaesthesiology , SVIMS , Alipiri road, Tirupati, Andhra pradesh, PIN:517507

Chittoor
ANDHRA PRADESH
517507
India 
Phone  9490573073  
Fax    
Email  subhadrapeyyety@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Janaki subhdra peyyety 
Designation  Professor , Department of Anaesthesiology , SVIMS 
Affiliation  Sri venkateswara institute of Medical sciences 
Address  Department of Anaesthesiology , SVIMS , Alipiri road, Tirupati, Andhra pradesh, PIN:517507

Chittoor
ANDHRA PRADESH
517507
India 
Phone  9490573073  
Fax    
Email  subhadrapeyyety@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr MALOTH RAJENDRA PRASAD 
Designation  Post Graduate , Department of Anaesthesiology , SVIMS 
Affiliation  Sri venkateswara institute of Medical sciences 
Address  Department of Anaesthesiology , SVIMS , Alipiri road, Tirupati, Andhra pradesh, PIN:517507

Chittoor
ANDHRA PRADESH
517507
India 
Phone  8008221516  
Fax    
Email  rajender45@gmail.com  
 
Source of Monetary or Material Support  
Sri Venkateswara institute of Medical Sciences , Alipiri road, Tirupati , chittoor, AP , 527507 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [] 
 
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 Janaki subhadra peyyety  Sri Venkateswara institute of Medical sciences  Department of Surgical oncology OT and surgical Gastroenterology OT
Chittoor
ANDHRA PRADESH 
9490573073

subhadrapeyyety@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SRI VENKATESWARA INSTITUTIONAL MEDICAL SCIENCES, TIRUMALA TIRUPATI DEVASTHANAMS, TIRUPATI, INSTITUTIONAL ETHICS COMMITTEE  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,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Morphine + Hyperbaric Bupivacaine + Dexmedetomidine.  Morphine 200mcg + 1ml of 0.5% Hyperbaric Bupivacaine + Dexmedetomidine 5mcg , Route -intrathecally stat dose after surgery. 
Comparator Agent  Morphine + Hyperbaric Bupivacaine + Magnesium sulphate.  Morphine 200mcg + 1ml of 0.5% Hyperbaric Bupivacaine + Magnesium sulphate 50mg , Route -intrathecally stat dose after surgery.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Patients Aged 18-65years.
2.Patients belonging to American society of anaesthesiologists (ASA PS) physical status grade I, II and III .
3.Patients scheduled to undergo major abdominal surgeries with expected duration of 3 to 4 hrs and

4.Patients willing to give the written consent to participate in the study will be included in the study.
 
 
ExclusionCriteria 
Details  Patients who are not willing to participate in the study.
Patients with history of intolerance or showing anaphylactic reaction to the medications used in the study.
Patients with severe hepatic, renal, cardiac and neurological disorders.
Pregnant and lactating women.
Patients who cannot understand or interpret VAS for pain assessment and
Patients who could not be positioned for regional technique post-surgery will be excluded from the study.
 
 
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 
To evaluate and compare the total morphine consumption between two groups in the first 24 hrs and second 24 hrs following surgery.  24hrs and 48hrs 
 
Secondary Outcome  
Outcome  TimePoints 
1.To assess the magnitude of pain by visual analogue Scale (VAS) at different points of time.
2.To assess sensory block by Hollmen scale.
3.To assess motor block by Bromage scale.
4.To find out time of first request of rescue analgesic between two groups.
5.To assess the time after which patient can do deep breathing exercises with the help of an incentive spirometer.
6.To assess incidence of side effects and complications (Nausea, Vomiting, pruritis postoperative respiratory depression, hemodynamic disturbances, sedation, sensory and motor block).
7.To assess the length of High dependency unit (HDU ) stay (ward worthiness).
8.To assess the overall patient’s satisfaction by visual analogue score.
9.Post operative sedation score will be assessed by Ramsay sedation score (RSS).



 
hourly in first 6hrs and then every 6hrs for 48 hrs 
 
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)   18/03/2024 
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   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Pain is an important hindrance to recovery from surgery and anaesthesia in the post-operative period.

  Poorly managed postoperative pain after any surgery can impair surgical outcomes. it may become chronic pain . it can result in a prolonged duration of the hospital stay.  

It can lead to more severe complications such as atelectasis, respiratory infection, myocardial infarction, and even bad surgical outcome or death and thus it increases overall costs for society

Adequate pain management is one of the most important factors in expediting recovery, by enabling fast mobilization.

Major abdominal incisions are commonly associated with persistent post-operative pain, in particular affecting respiratory function and also associated with increased analgesic requirement .

Effectively administered analgesia enables greater patient satisfaction by minimizing acute postoperative pain. 

Through alleviating the acute physiological stress response to surgery it facilitates enhanced recovery outcomes including early mobilisation and return to normal activity, reduced length of hospital stay, and reduced cardiac, respiratory and gastrointestinal postoperative complications leading to improved long-term patient survival rates.

Opioids remain the main stay of treatment in these situations where there will be a continuous noxious stimulus from the incision site because of the ongoing respiratory excursions. Even though opioids are the most effective forms of medication that are being used in relieving pain ,they are associated with severe systemic side effects and potential risk of addiction. Therefore, a general goal is to minimize exposure to the side effects of prolonged systemic narcotics while ensuring adequate analgesia.

This can be achieved with a multimodal approach combining regional anaesthesia, centrally-acting analgesics such as paracetamol, and drugs with a peripheral nonsteroidal anti-inflammatory effect  to minimize the opioid-related side effects while maintaining an effective level of pain control.

To evaluate and compare the total morphine consumption between two groups in the first 24 hrs and second 24 hrs following surgery. 

 The current study is designed to evaluate and compare the usefulness of Dexmedetomidine or magnesium sulphate as an additional adjuvant to a combination of intrathecal bupivacaine  and morphine for post operative analgesia in major abdominal surgeries.


 
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