| CTRI Number |
CTRI/2023/04/051732 [Registered on: 18/04/2023] Trial Registered Prospectively |
| Last Modified On: |
18/04/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
comparison of the effects of combination of two drugs used for giving spinal anesthesia for surgeries below the umbilicus. |
|
Scientific Title of Study
|
Comparison of the effects of the intrathecal dexmedetomidine versus clonidine as an adjuvant to hyperbaric ropivacaine 0.75% for infraumbilical surgeries: A prospective randomised 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 Shruti Desai |
| Designation |
Assistant Professor |
| Affiliation |
GCS medical college, hospital and research centre |
| Address |
Room no. 105, Anesthesia Department, ground floor, GCS hospital building, opp. DRM office, Naroda Road, nr. Chamunda Bridge, Ahmedabad, Gujarat - 380025
opp.DRM office, Naroda Road, Nr. Chamunda Bridge, Ahmedabad, Gujarat - 380025
Ahmadabad
GUJARAT
380025
India |
| Phone |
9429525791 |
| Fax |
|
| Email |
shru30791@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shruti Desai |
| Designation |
Assistant Professor |
| Affiliation |
GCS medical college, hospital and research centre |
| Address |
Room no. 105, Anesthesia Department, ground floor, GCS hospital building, opp. DRM office, Naroda Road, nr. Chamunda Bridge, Ahmedabad, Gujarat - 380025
opp.DRM office, Naroda Road, Nr. Chamunda Bridge, Ahmedabad, Gujarat - 380025
Ahmadabad
GUJARAT
380025
India |
| Phone |
9429525791 |
| Fax |
|
| Email |
shru30791@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shruti Desai |
| Designation |
Assistant Professor |
| Affiliation |
GCS medical college, hospital and research centre |
| Address |
Room no. 105, Anesthesia Department, ground floor, GCS hospital building, opp. DRM office, Naroda Road, nr. Chamunda Bridge, Ahmedabad, Gujarat - 380025
opp.DRM office, Naroda Road, Nr. Chamunda Bridge, Ahmedabad, Gujarat - 380025
Ahmadabad
GUJARAT
380025
India |
| Phone |
9429525791 |
| Fax |
|
| Email |
shru30791@gmail.com |
|
|
Source of Monetary or Material Support
|
| GCS medical college, Hospital and Research Centre |
|
|
Primary Sponsor
|
| Name |
Dr Shruti Desai |
| Address |
A-301, Shahibag Greens, opp. Dolphin Club, Nr. Police Headquarters, Shahibag, Ahmedabad, Gujarat- 380004 |
| Type of Sponsor |
Other [self] |
|
|
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 Shruti Desai |
GCS Medical College, Hospital and Research Centre |
Anesthesia Department, Ground floor, GCS hospital, Opp. DRM Office, Naroda Rd, Nr. Chamunda Bridge, Ahmedabad, Gujarat- 380025
Ahmadabad
GUJARAT |
9429525791
shru30791@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE GCS Medical College, Hospital & Research Centre (IECGCSMCH&RC) |
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 |
| Comparator Agent |
Intrathecal Ropivacaine plus Clonidine |
In this group 3 ml of 0.75% hyperbaric Ropivacaine + 30 ug of clonidine in 0.5ml normal saline. Total volume 3.5ml will be given intrathecally. patient will be observed postoperatively for 24 hrs. |
| Comparator Agent |
Intrathecal Ropivacaine plus Dexmedetomidine |
In this group 3 ml of 0.75% hyperbaric Ropivacaine + 5 ug dexmedetomidine in 0.5ml normal saline. Total volume 3.5ml will be given intrathecally. Patient will be observed postoperatively for 24 hrs. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade I and II
BMI< 30 kg/m2
Patients who have given written informed consent.
Patients undergoing elective infraumbilical surgeries under spinal anaesthesia |
|
| ExclusionCriteria |
| Details |
1.ASA grade III and IV
2.Patients with known psychiatric illness, chronic pain or any condition that precludes intrathecal anesthesia.
3.Patients with deformity of the spine.
4.Patients with skin infection at the site of anesthesia.
5.Known sensitivity or allergy to the study drugs
6.Patients on chronic anticoagulants or antit platelet drugs or patients with coagulopathy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the onset and duration of sensory and motor blockade and duration of postoperative analgesia |
The effects will be assessed at baseline,5,10,15, 20,25,30,60,90,120,150,180 minutes after giving spinal anesthesia.Postoperatively the analgesia effect will be assessed at baseline, 1,2,3,4,5,6,12 and 24 hours postoperatively. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to assess perioperative hemodynamic stability and incidence of side effects |
The hemodynamic stobility and adverse effects will be assessed intraoperatively at baseline,5,10,15, 20,25,30,60,90,120,150,180 minutes after giving spinal anesthesia. And Postoperatively it will be assessed at baseline, 1,2,3,4,5,6,12 and 24 hours postoperatively. |
|
|
Target Sample Size
|
Total Sample Size="180"
Sample Size from India="180"
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 4 |
|
Date of First Enrollment (India)
|
25/04/2023 |
| 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="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
|
Ours is a prospective randomised observational study. we will take 180 patients posted for elective infraumbilical surgery of either gender in the age group of 18-60 years with ASA grade I or II. Patients will be randomly divided into two groups of 90 patients each based on closed envelope method. Group RC: will receive 3 ml of 0.75% hyperbaric ropivacaine + 30 ug of clonidine in 0.5 ml normal saline. Total volume 3.5 ml intrathecally. Group RD: will receive 3 ml of 0.75% hyperbaric ropivacaine + 5 ug dexmedetomidine in 0.5 ml normal saline. Total volume 3.5 ml intrathecally. The parameters assessed will be - onset of sensory block, onset of motor block, time to highest sensory level, time to modified Bromage scale 3, time to S2 segment regression, time to modified Bromage scale 0, time to first rescue analgesic and adverse effects like nausea, vomiting, shivering, hypotension, bradycardia. VAS score will be assessed postoperatively for first 24 hrs. Intraoperative vitals will be monitored immediately after spinal block, then every 5 mins for the first half hr and then every 30 mins till the end of surgery. Postoperatively the vitals will be monitored immediately postoperatively and then every hourly till 6 hrs and then at 12 hrs and 24 hrs. |