| 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
|
|
|
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
|
|
|
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.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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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
|
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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. |