| CTRI Number |
CTRI/2023/09/057299 [Registered on: 06/09/2023] Trial Registered Prospectively |
| Last Modified On: |
04/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
To compare the pain relief in patients after operation ,with different doses of Dexmedetomidine
(a drug )as added drug to Bupivacaine given in spinal anaesthesia & Bupivacaine alone in Open Uterine surgeries |
|
Scientific Title of Study
|
Comparative study of the duration of post operative analgesia with different doses of intrathecal Dexmedetomidine as adjuvant to 0.5% Hyperbaric Bupivacaine & with Bupivacaine alone in Total Abdominal Hysterectomy surgeries. - randomized double blind study. |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Kavya T |
| Designation |
Junior resident |
| Affiliation |
Jubilee Mission Medical College and Research Institute |
| Address |
Jubilee Mission Medical College and Research Institute ,Department of Anaesthesia and Critical Care
Eastfort Trissur
Kerala
India
Thrissur
KERALA
680005
India |
| Phone |
8281958073 |
| Fax |
|
| Email |
kavuz57t@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Davies C V |
| Designation |
Professor |
| Affiliation |
Jubilee Mission Medical College and Research Institute |
| Address |
Jubilee Mission Medical College and Research Institute ,Department of Anaesthesia and Critical Care
Eastfort Thrissur
Kerala
INDIA
Thrissur
KERALA
680005
India |
| Phone |
9387890689 |
| Fax |
|
| Email |
daviescv@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Davies C V |
| Designation |
Professor |
| Affiliation |
Jubilee Mission Medical College and Research Institute |
| Address |
Jubilee Mission Medical College and Research Institute ,Department of Anaesthesia and Critical Care
Eastfort Thrissur
Kerala
India
Thrissur
KERALA
680005
India |
| Phone |
9387890689 |
| Fax |
|
| Email |
daviescv@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jubilee Mission Medical College and Research Institute, Eastfort Thrissur |
|
|
Primary Sponsor
|
| Name |
Jubilee Mission Medical College and Research Institute |
| Address |
Jubilee Mission Medical College and Research Institute ,Department of Anaesthesia and Critical Care
Eastfort Trissur
Kerala
India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Kavya T |
Jubilee Mission Medical College and Research Institute |
Diamond Jubilee Block,Room Number 18,Eastfort Thrissur
680005
Kerala
Thrissur
KERALA |
8281958083
kavuz57t@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutionl Ethics Commitee Jubilee Mission Medical College and Research Institute Eastfort Thrissur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N852||Hypertrophy of uterus, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Duration of postoperative analgesia |
Duration of post operative analgesia with Dexmedetomidine 5 mcg and 10 mcg in Subarachnoid block as adjuvant to 0.5 % Bupivacaine |
| Intervention |
Subarachnoid Block |
Administration of Subarachnoid Block in Total Abdominal Hysterectomy Surgeries with Dexmedetomidine 5 mcg and 10 mcg as adjuvant to Buoivacaine - 18 months duration of study |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
ASA I & ASA II
PATIENTS SCHEDULED TOTAL ABDOMINAL HYSTERECTOMY |
|
| ExclusionCriteria |
| Details |
Patients with baseline Heart rate < 60 or on Beta blockers / Alpha agonist.
Patient refusal for study participation .
Local infection at injection site.
Presence of any coagulopathies or bleeding disorders or patients on anticoagulation.
PRESENCE OF NEUROLOGICAL DEFICITS, PERIPHERAL NEUROPATHIES, MYOPATHIES, OR CHRONIC PAIN IN THE OPERATING LIMB.
PATIENTS WITH KNOWN ALLERGY TO LOCAL ANAESTHETICS OR TO ANY STUDY DRUGS TO BE USED.
HEMODYNAMICALLY COMPROMISED PATIENTS
ALCOHOLIC/ PSYCHIATRIC/UNCOOPERATIVE PATIENTS
PATIENTS WITH HEPATIC / RENAL OR CARDIOPULMONARY DISORDERS.
PATIENTS LESS THAN 5 FEET HEIGHT.
TOTAL ABDOMINAL HYSTERECTOMY TAKING > 3 HRS. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Dexmedetomidine 10 mcg was a better adjuvant compared to 5 mcg in terms of better post operative analgesia when used as intrathecal adjuvant to Bupivacaine in subarachnoid block |
Post operative analgesia assessed every 6 hours after the requirement of first dose of analgesic |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Onset of sensory block
Onset of motor block
Level of block achieved Duration of sensory block
Duration of motor block |
After administration of subarachnoid block
Onset of block ever 2 minutes
Duration of block every 6 hours
|
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
15/09/2023 |
| 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
|
Once completed ,we wish to analyse the data and publish the trial in a pubmed indexed journal |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response (Others) - All details published will not have patient name
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response (Others) - All details published will not have patient name
- Who will be able to view these files?
Response (Others) - All details published will not have patient name
- For what types of analyses will this data be available?
Response (Others) - All details published will not have patient name
- By what mechanism will data be made available?
Response (Others) - All details published will not have patient name
- For how long will this data be available start date provided 28-02-2025 and end date provided 28-02-2028?
Response (Others) - All details published will not have patient name
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This study is being undertaken to evaluate and compare the duration of postoperative analgesia with different doses of intrathecal Dexmedetomidine , as adjuvant to Bupivacaine in Total Abdominal Hysterectomy surgeries , and their side effect profile ( As evidenced by Hypotension and Bradycardia ).Dexmedetomidine 10 mcg was a better adjuvant compared to 5 mcg in terms of better post operative analgesia without increased incidence of side effects when used as intrathecal adjuvant to Bupivacaine in subarachnoid block |