| CTRI Number |
CTRI/2020/05/025192 [Registered on: 15/05/2020] Trial Registered Prospectively |
| Last Modified On: |
13/05/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Anaesthesia study comparing two drugs,having different mechanism of actions.The study is done on patients undergoing Gynecological surgery and the technique is Combined Spinal Epidural technique. |
|
Scientific Title of Study
|
Comparative study of effect of Dexmedetomidine and Fentanyl as epidural adjuvants in Abdominal Hysterectomies using Combined spinal epidural technique-A randomized prospective study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shilaga Dhar |
| Designation |
Post Graduate |
| Affiliation |
Government Medical College Jammu |
| Address |
Post Graduate Department of Anaesthesiology and Intensive Care
Government Medical College
Jammu
Jammu
JAMMU & KASHMIR
180001
India |
| Phone |
7889433509 |
| Fax |
|
| Email |
sdhar8846@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Naine Gupta |
| Designation |
Assistant Professor |
| Affiliation |
Government Medical College and Hospital Jammu |
| Address |
Post Graduate Department of Anaesthesiology and Intensive Care
Government Medical College
Jammu
Jammu
JAMMU & KASHMIR
180001
India |
| Phone |
9419781087 |
| Fax |
|
| Email |
naine1978@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Naine Gupta |
| Designation |
Assistant Professor |
| Affiliation |
Government Medical College and Hospital Jammu |
| Address |
Post Graduate Department of Anaesthesiology and Intensive Care
Government Medical College
Jammu
Jammu
JAMMU & KASHMIR
180001
India |
| Phone |
9419781087 |
| Fax |
|
| Email |
naine1978@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Medical College and Hospital Jammu
Bakshi Nagar
Jammu-180001
JAMMU & KASHMIR |
|
|
Primary Sponsor
|
| Name |
Government Medical College and Hospital Jammu |
| Address |
Government Medical College and Hospital
Bakshi Nagar
Jammu |
| Type of Sponsor |
Government 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 |
| Dr Shilaga Dhar |
Government Medical College and Hospital Jammu |
Postgraduate Department of Anesthesiology and Intensive Care
Government Medical College and Hospital
Bakshi Nagar
jammu
Jammu
JAMMU & KASHMIR |
7889433509
sdhar8846@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government Medical College and Hospital Jammu Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N859||Noninflammatory disorder of uterus, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Bupivacaine and Dexmedetomidine |
3ml of 0.5% Bupivacaine (Heavy) will be given intrathecally. Dexmedetomidine 1microgram/kg body weight diluted in saline total making it 10ml will be given through epidural catheter. Both drugs will be given using Combined Spinal Epidural Technique. Bupivacaine will be given through intrathecal route and dexmedetomidine through epidural route just before the surgery. |
| Comparator Agent |
Bupivacaine and Fentanyl |
3ml of 0.5% Bupivacaine (Heavy) will be given intrathecally. Fentanyl 0.5microgram/kg body weight diluted in saline total making it 10ml will be given through epidural catheter. Both drugs will be given using Combined Spinal Epidural Technique.Bupivacaine will be given through intrathecal route and fentanyl through epidural route just before the surgery. |
| Intervention |
Epidural adjuvants in abdominal hysterectomies using Combined Spinal Epidural technique |
Two drugs dexmedetomidine(1microgram/kg diluted in saline total making it 10ml) and fentanyl(0.5microgram/kg diluted in saline total making it 10ml) with intrathecal bupivacaine 0.5% heavy3ml will be given through Combined Spinal Epidural Technique in two patient groups undergoing abdominal hysterectomy.The duration of intervention will start just before the surgery when the drugs will be administered through combined spinal epidural route upto 180 minutes post operatively and till patients will require first rescue analgesia. |
|
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Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
1.60 Female patients
2.ASA Grade I and II
3.Scheduled for abdominal hysterectomy |
|
| ExclusionCriteria |
| Details |
1.ASA Grade>II
2.Patients with contraindication for neuraxial anesthesia
3.Patients with history of local anesthetic allergy
4.Obese patients (BMI>35)
5.Patients not willing for regional anaesthesia |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study and compare effect of dexmedetomidine and fentanyl given epidurally in abdominal hysterectomies with intrathecal bupivacaine using CSE technique. |
180 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To see and compare the duration and quality of post operative analgesia & complications if any in two groups. |
180 minutes |
|
|
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)
|
18/05/2020 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
The study will be conducted in the Post Graduate Department of Anaesthesiology and Intensive Care, Government Medical College Jammu after getting clearance from institutional ethics comittee. The patients enrolled will be explained about the study and a written informed consent will be taken. INCLUSION CRITERIA:
1. ASA Grade I and II
2. 30-60 years females
3. Scheduled for abdominal hysterectomy
EXCLUSION CRITERIA:
1. ASA Grade > II
2. Patients with contraindications for neuraxial anesthesia
3. Patients with history of local anesthetic allergy
4. Obese patients (BMI > 35)
5. Patients not willing for regional anaesthesia
Using CSE technique drugs will be given to the patients divided in two groups of 30 each and the two drugs dexmedetomidine and fentanyl will be compared. Sensory blockade, Motor blockade, duration of analgesia and sedation will be noted inta operatively and post operatively and will be scored and recorded. All the cardiorespiratory parameters of heart rate, blood pressure and spo2 will be monitored continuously and recorded. Data so collected will be analysed, compared and subjected to statistical analysis. |