| CTRI Number |
CTRI/2024/04/065749 [Registered on: 16/04/2024] Trial Registered Prospectively |
| Last Modified On: |
11/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Exploring effectiveness of intravenous Dexmedetomidine versus Tramadol in participants for post spinal anesthesia shivering management and comparison of the two drugs and understanding the primary outcome. |
|
Scientific Title of Study
|
Comparison of intravenous Dexmedetomidine vs Tramadol as anti-shivering agent following spinal anesthesia |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ruchita Sunil Raikar |
| Designation |
Junior resident in anesthesia department |
| Affiliation |
junior resident |
| Address |
Department of Anesthesiology, Eras medical college and hospital, Lucknow, Eras medical college and hospital, sarfarazganj, Lucknow, UP, Lucknow, Uttar Pradesh, 226003
India
Department of Anesthesiology, Eras medical college and hospital, Lucknow, Eras medical college and hospital, sarfarazganj, Lucknow, UP, Lucknow, Uttar Pradesh, 226003
India
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9619716371 |
| Fax |
|
| Email |
ruchitaraikar99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prof Maj Sanjay Choubey |
| Designation |
Head of department of Anesthesiology |
| Affiliation |
Eras medical college and hospital |
| Address |
Eras Medical college and hospital, Sarfarzganj, Lucknow
Uttar Pradesh
226003
India
Eras Medical college and hospital, Sarfarzganj, Lucknow
Uttar Pradesh
226003
India
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
8840155309 |
| Fax |
|
| Email |
sanjay.choubey@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prof Maj Sanjay Choubey |
| Designation |
Head of department of Anesthesiology |
| Affiliation |
Eras medical college and hospital |
| Address |
Eras Medical college and hospital, Sarfarzganj, Lucknow
Uttar Pradesh
226003
India
UTTAR PRADESH
226003
India |
| Phone |
8840155309 |
| Fax |
|
| Email |
sanjay.choubey@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Ruchita Raikar, Eras Lucknow Medical College and hospital, Lucknow, Uttar Pradesh -226003 |
|
|
Primary Sponsor
|
| Name |
Eras medical college and hospital |
| Address |
Sarfarzganj, Lucknow,
Uttar Pradesh
226003
India |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Ruchita Sunil Raikar |
Operation Theatre |
Eras medical college and hospital,
Lucknow,
Uttar Pradesh
226003
India
Lucknow
UTTAR PRADESH |
9619716371
ruchitaraikar99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Eras Lucknow Medical college and hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, (2) ICD-10 Condition: 8||Other Procedures, (3) ICD-10 Condition: 3||Administration, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Comparison between Dexmedetomidine and Tramadol as anti-shivering agent post spinal anesthesia |
Patients shall be visited on the evening prior to surgery
They shall be re evaluated and pre anesthetic orders checked. Written and informed consent for anesthesia and for the study shall be obtained.
Patients shall be kept nill per oral from midnight prior to surgery. On the day of surgery patients shall be assessed preoperatively, vitals shall be noted and intravenous access shall be secured. Patients shall be shifted to OT under constant reassurance.Standard monitors shall be attached and baseline parameters shall be recorded- Heart Rate (HR), Oxygen saturation (SpO2 ), Non-invasive blood pressure (NIBP) and ECG.Ringer Lactate infusion shall be started.
No means of active warming will be used. Under all aseptic precautions spinal anaesthesia will be administered at the L3 – L4 intervertebral space, with the patient in sitting position.
A volume of 3 ml of inj. bupivacaine 0.5% (heavy) shall be injected through a 27-gauge Quincke’s spinal needle. Patient shall be placed in supine position with a 15° head down tilt immediately after administration of the block.Oxygen (5L/min) shall be administered via face mask.
Vitals shall be recorded every 5 minutes for first 30 minutes and after that, every 15 minutes till the end of the surgery. Temperature shall be recorded with thermometer probe every 5 minutes for 30 minutes and after that every 15 minutes till the end of the surgery.Appearance of shivering of moderate to severe shall be noted and the patient shall be randomized in one of the two groups by using the lottery method of randomization into (group A and group B) and the study drug shall be administered thereafter. Time taken to relieve shivering shall be recorded.Hypotension, defined as a decrease of mean arterial blood pressure(MAP) by more than 20% from baseline, shall be treated with incremental intravenous doses of phenylephrine 50 mcg and intravenous fluid as required.Bradycardia, defined as heart rate 50 beats per minute, shall be treated with intravenous Atropine 0.6 mg. After the end of surgery patients shall be shifted to the recovery room and observed. |
| Comparator Agent |
Dexmedetomidine, Tramadol |
Comparision of intravenous Dexmedetomidine vs Tramadol as anti-shivering agent following spinal anesthesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
American society of anesthesiologists (ASA) physical status grade 1 and 2, patients who develop shivering post sub arachnoid block (spinal anesthesia) |
|
| ExclusionCriteria |
| Details |
patient refusal, pregnancy, patients with known hypersensitivity to study drugs, ischemic heart disease, hepatic disease, hyperthyroidism, hypothyroidism, urinary tract infection, diabetes mellitus, known history of substance or alcohol abuse |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| the primary outcome of the study is to compare the effectiveness of intravenous dexmedetomidine versus tramadol as a anti shivering agent post spinal anesthesia and better agent that helps in subsiding the shivering faster with least amount of side effects. |
time noted after onset of shivering and time taken to subside the shivering. vitals measured at every 5 minute interval till 30 minutes and every 15 minutes till end of surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| side effects to be noted such as nausea, vomiting, bradycardia etc |
at the end of study |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
24/04/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
.Shivering is a common postanesthesia adverse event with an incidence of 40–70%. Shivering is not only physically distressing for the patient, but can have various other detrimental effects. It may lead to pain, patient discomfort, impede monitoring techniques, increase intraocular and intracranial pressures, double or even triple oxygen consumption and carbon dioxide production, which might pose difficulties in patients with existing intrapulmonary shunts, fixed cardiac output or limited respiratory reserve. Therefore by comparing the anti-shivering effect of Dexmedetomidine vs Tramadol post spinal anesthesia, a outcome can be achieved for a better anti-shivering agent amongst the two agents. |