| CTRI Number |
CTRI/2024/03/064407 [Registered on: 19/03/2024] Trial Registered Prospectively |
| Last Modified On: |
16/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Preventive |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A study to compare between two drugs dexmedetomidine and fentanyl with a control group for the prevention of shivering after spinal anaesthesia in endoscopic urosurgical cases. |
|
Scientific Title of Study
|
A prospective randomized controlled study comparing intrathecal dexmedetomidine and intrathecal fentanyl for the prevention of post-spinal anaesthesia shivering in endoscopic urosurgical cases. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR ILAKKIYA U |
| Designation |
DNB Anaesthesia Resident |
| Affiliation |
Sri Narayani Hospital And Research Centre |
| Address |
Department of Anaesthesia,C BLOCK OPERATION THEATRE, Sri Narayani Hospital and Research Centre
Vellore
TAMIL NADU
632055
India |
| Phone |
8098008631 |
| Fax |
|
| Email |
ilexilaky6@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR B. S. KRISHNAN |
| Designation |
HOD ANAESTHESIA |
| Affiliation |
Sri Narayani Hospital And Research Centre |
| Address |
Department of Anaesthesia, C BLOCK, Room no 401, Sri Narayani Hospital and Research Centre
Vellore
TAMIL NADU
632055
India |
| Phone |
6380546634 |
| Fax |
|
| Email |
b_s_krishnan@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR ILAKKIYA U |
| Designation |
DNB Anaesthesia Resident |
| Affiliation |
Sri Narayani Hospital And Research Centre |
| Address |
Department of Anaesthesia, C BLOCK OPERATION THEATRE, Sri Narayani Hospital and Research Centre
Vellore
TAMIL NADU
632055
India |
| Phone |
8098008631 |
| Fax |
|
| Email |
ilexilaky6@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Narayani Hospital and Research Center, Sripuram , Vellore. |
|
|
Primary Sponsor
|
| Name |
Sri Narayani Hospital and Research Centre |
| Address |
Department of Anaesthesia,C BLOCK, Sri Narayani Hospital and Research Center,Thirumalaikodi,Vellore
Tamilnadu
PINCODE - 632055
|
| 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 ILAKKIYA U |
Sri Narayani Hospital and Research Centre |
Department of Anaesthesia
Operation Theatre.
Vellore
TAMIL NADU |
8098008631
ilexilaky6@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Narayani Hospital and Research Centre Institutional 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 |
Dexmedetomidine |
5 micrograms dexmedetomidine with 12.5-15 milligrams of 0.5% heavy bupivacaine to be administered intrathecal route before surgical procedure and procedure will not exceed more than 3 hrs |
| Intervention |
Fentanyl |
25 micrograms fentanyl with 12.5-15 milligrams of 0.5% heavy bupivacaine to be administered intrathecal route before surgical procedure and procedure will not exceed more than 3 hours |
| Comparator Agent |
normal saline |
0.5 millilitre normal saline with 12.5-15 milligrams of 0.5% heavy bupivacaine to be administered intrathecal route before surgical procedure and procedure will not exceed more than 3 hours |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. patients undergoing endoscopic urosurgical procedurs like URS and TURP
2. ASA grade 1 and 2
3. surgical procedure expected to last less than 3 hours. |
|
| ExclusionCriteria |
| Details |
1. patient with absolute contraindication to spinal anaesthesia
2. patient refusal
3. known allergy to any of the study drugs
4. ASA grade 3 and onwards
5. thyroid disease, parkinsons disease
6. patients on beta blockers
7. prostate size more than 100cc |
|
|
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 |
| Assess the incidence and severity of shivering |
baseline, every 5 minutes for first 30 minutes and every 15 minutes for next 2 hours 30 minutes.
minutes-0,5,10,15,30,45,60,75,90,105,120,135,150,165,180 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assess the duration of sensory block & adverse effects such as hypotension, bradycardia, nausea & vomiting. |
baseline, every 5 minutes for next 30 minutes and every 15 minutes for next 2 hours 30 minutes.
minutes- 0,5,10,15,30,45,60,75,90,105,120,135,150,165,180 |
|
|
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 4 |
|
Date of First Enrollment (India)
|
30/03/2024 |
| 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="0"
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
|
Spinal anaesthesia is a common technique for uroscopic procedures. Shivering is a common side effect after spinal anaesthesia due to inhibition of tonic vasoconstriction thereby causing redistribution of heat from trunk to peripheral areas. It is more common in endoscopic surgeries due to absorption of large amount of cold irrigating fluids. Shivering is an involuntary , spontaneous and repetitive activity of the muscles. It leads to patient distress, impairment in monitoring , increased oxygen consumption and carbon dioxide production. Dexmedetomidine is a highly selective alpha 2 adrenorecptor agonist which decreases the sympathetic tone. Side effects include hypotension , bradycardia, drymouth and nausea. fentanyl is a phenylpiperidine derivative synthetic opioid. It ha effect on spinal afferent thermal inputs and thermoregulator at spinal cord. side effects include hypotension, bradycardia, urinary retention, pruritis, nausea and vomiting. In this study we will compare the incidence and grades of shivering , duration of sensory block , hypotension, bradycardia, nausea and vomiting between 3 groups group D receiving intrathecal dexmedetomidine , group F receiving intrathecal fentanyl and group C receiving normal saline as adjuvants with 12.5- 15 mg of 0.5% heavy bupivacaine. |