| CTRI Number |
CTRI/2021/04/032612 [Registered on: 07/04/2021] Trial Registered Prospectively |
| Last Modified On: |
06/04/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to assess the efficacy of Dexamethasone as an adjuvant in ultrasound guided cervical plexus block using Bupivacaine 0.25% in patients undergoing thyroid surgery under general anesthesia |
|
Scientific Title of Study
|
A study to evaluate the efficacy of Dexamethasone as an adjuvant in ultrasound guided cervical plexus block using Bupivacaine 0.25% in patients undergoing thyroid surgeries under entropy guided general Anesthesia- A randomised control 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 Archana M |
| Designation |
Post graduate |
| Affiliation |
Bangalore medical college and research institute |
| Address |
Department of Anesthesiology, Bangalore medical college and research institute, Fort, Krishna Rajendra Road, Bengaluru
Bangalore
KARNATAKA
560002
India |
| Phone |
9663310314 |
| Fax |
|
| Email |
archanamanoharan25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Satish Kumar M N |
| Designation |
Assistant Professor |
| Affiliation |
Bangalore medical college and research institute |
| Address |
Department of Anesthesiology, Bangalore medical college and research institute, Fort, Krishna Rajendra Road, Bengaluru
Bangalore
KARNATAKA
560002
India |
| Phone |
9916207210 |
| Fax |
|
| Email |
drsats007@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Satish Kumar M N |
| Designation |
Assistant professor |
| Affiliation |
Bangalore medical college and research institute |
| Address |
Department of Anesthesiology, Bangalore medical college and research institute, Fort, Krishna Rajendra Road, Bengaluru
Bangalore
KARNATAKA
560002
India |
| Phone |
9916207210 |
| Fax |
|
| Email |
drsats007@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesiology, Bangalore medical college and research institute, Fort, Krishna Rajendra Road, Bengaluru 560002 |
|
|
Primary Sponsor
|
| Name |
Dr Archana M |
| Address |
Department of Anesthesiology, Bangalore medical college and research institute, Fort, Krishna Rajendra Road, Bengaluru |
| Type of Sponsor |
Other [] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Satish Kumar M N |
Department of Anesthesiology, Bangalore medical college and research institute, Fort, Krishna Rajendra Road, Bengaluru |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Archana M |
Bangalore medical college and research institute |
Department of Anesthesiology, Bangalore medical college and research institute, Fort, Krishna Rajendra Road, Bengaluru
Bangalore
KARNATAKA |
9663310314
archanamanoharan25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BMCRI 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 |
Bupivacaine 0.25% |
20ml Bupivacaine 0.25% using ultrasound guided bilateral superficial cervical plexus block before general Anesthesia |
| Comparator Agent |
Bupivacaine 0.25% and dexamethasone |
19ml Bupivacaine 0.25% plus dexamethasone 4mg using ultrasound guided bilateral superficial cervical plexus block before general Anesthesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients who have given informed written consent
2. Patients with ASA grade 1 and 2
3. Patients ages 18-60years of either sex
4. Patients scheduled for elective thyroid surgeries lasting for 60 to 150 minutes |
|
| ExclusionCriteria |
| Details |
1. Patients not willing to give informed consent
2. Patients with allergy to Bupivacaine
3. Patients diagnosed with vocal cord palsy by preoperative indirect laryngoscopes
4. Patients with thyroid mass extending retrosternalily, any gross compression or deviation of trachea
5. Patients scheduled for extensive radical neck dissection
6. Patients with electrolyte abnormalities, hepatic or renal insufficiency, coagulation disorder, hypertension or cardiac disorders
7. Pregnant and breast feeding women |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Hemodynamic stability |
Hemodynamic stability |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Isoflurane consumption |
Intraoperative period |
| Analgesia |
Post operative period |
| Other adverse effects |
Post operative period |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
12/04/2021 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a prospective randomised control trial to study the effect of dexamethasone as an adjuvant with bupivacaine 0.25% versus Bupivacaine 0.25% alone using ultrasound guided superficial cervical plexus block in patients undergoing thyroid surgeries under entropy guided general Anesthesia of duration less than 2 hours 30mins. It will be conducted in a total of 80patients, 40 in each group in all hospitals attached to Bangalore medical college and research institute. The primary outcome is to compare hemodynamic variables intraoperatively. Isoflurane consumptions, entropy intraoperatively and postop analgesia and side effects will be observed in the post operative period |