| CTRI Number |
CTRI/2018/01/011126 [Registered on: 04/01/2018] Trial Registered Retrospectively |
| Last Modified On: |
06/01/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study the effect of two drugs, Dexmedetomidine and Fentanyl in patients requiring ear surgery |
|
Scientific Title of Study
|
Comparison of Dexmedetomidine and Fentanyl for tympanoplaty surgery under Monitored Anaesthesia Care |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Suman Shekhar Tiwari |
| Designation |
PG student |
| Affiliation |
Dhiraj general hospital |
| Address |
Dhiraj general hospital SBKS MI and RC Sumandeep vidyapeeth Piparia Waghodia Vadodara
Dhiraj general hospital SBKS MI and RC Sumandeep vidyapeeth Piparia Waghodia Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9978621648 |
| Fax |
|
| Email |
rinkushekhar@gmail.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Suman Shekhar Tiwari |
| Designation |
PG Student |
| Affiliation |
Dhiraj general hospital |
| Address |
Dhiraj general hospital SBKS MI and RC Sumandeep vidyapeeth Piparia Waghodia Vadodara
D 16 staff quaters Sumandeep vidyapeeth campus Piparia Waghodia Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
919978621648 |
| Fax |
|
| Email |
rinkushekhar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suman Shekhar Tiwari |
| Designation |
Assistant Professor |
| Affiliation |
Dhiraj general hospital |
| Address |
Dhiraj general hospital SBKS MI and RC Sumandeep vidyapeeth Piparia Waghodia Vadodara
Dhiraj general hospital SBKS MI and RC Sumandeep vidyapeeth Piparia Waghodia Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9978621648 |
| Fax |
|
| Email |
rinkushekhar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dhiraj general hospital SBKS MI AND RC,Sumandeep Vidyapeeth Deemed University |
|
|
Primary Sponsor
|
| Name |
Dhiraj general hospital |
| Address |
Dhiraj general hospital SBKS MI AND RC Sumandeepvidyapeeth Piparia, Waghodia Vadodara Gujarat- 391760 |
| Type of Sponsor |
Private 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 Suman Shekhar Tiwari |
Dhiraj general hospital |
Dhiraj general hospital SBKS MI and RC Sumandeep vidyapeeth Piparia Waghodia
Vadodara
GUJARAT |
9978621648
rinkushekhar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sumandeep Vidyapeeth Institutional Ethics Committee (SVIEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients undergoing tympanoplasty surgery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Injection Dexmedetomidine |
Injection dexmedetomidine 1 microgram/kg over 10 minutes i.v infusion as loading dose and maintenance dose as 0.5 microgram/kg/hour i.v |
| Comparator Agent |
Injection Fentanyl |
Injection Fentanyl 1 microgram/kg i.v loading dose and maintenance 0.5 microgram/kg/hour i.v |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients willing to give informed and written consent
Patients belonging to ASAphysical status I and II
Patients posted for planned surgery |
|
| ExclusionCriteria |
| Details |
Patients with severely compromising respiratory/cardiac/renal and hepatic dysfunction
Morbidly Obese patients
Pregnant and lactating women
Patient with anticipated difficult airway |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Ramsay sedation score
Boezaart scale
Hemodynamic parameters |
every half an hourly intraoperatively
Boezaart scale-throughout surgery
Hemodynamic parameters-throughout surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| VAS Score |
every half an hourly postoperatively till VAS score is more than 4 |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
19/09/2016 |
| Date of Study Completion (India) |
30/08/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="11"
Days="11" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
not sent for publication yet. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a randomised, double blind, parallel group trial comparing the safety and efficacy of Dexmedetomidine 1 microgram/kg over 10 minutes i.v infusion as loading dose and maintenance dose as 0.5 microgram/kg/hour and Fentanyl 1 microgram/kg i.v as loading dose and maintenance dose as 0.5 microgram/kg/hour in ASAPS I and II patients undergoing elective tympanoplsty surgery that was conducted in single centre in india. Primary outcome measures were Ramsay sedation score, VAS score, Boezaart score and hemodynamic parameters.The purpose of this study is to compare fentanyl ; most commonly used opioid based analgesic with dexmedetomidine which is a novel drug commonly used for Monitered anaesthesia care now a days.In our study Ramsay sedation scale remained significantly higher in fentanyl group compared to dexmedetomidine group,the scale remained between 2-4 in all the patients during surgery which was adequate for the procedure to be performed.Analgesic effect of dexmedetomidine and fentanyl were comparable till 90 minutes in our study but after that analgesia provided by dexmedetomidine was better compared to fentanyl. Similar effects were found by the previous study, which was explained by the opioid sparing analgesic effect of dexmedetomidine. Although MAP remained stable in both groups, significant fall in heart rate was seen after 60 min in dexmedetomidine receiving patients compared to fentanyl receiving patients which can be explained by alpha 2 agonistic effect of dexmedetomidine. No clinically significant change in hemodynamic parameters were recorded during the study. Surgeon’s satisfaction in terms of Boezaart’s score was better in dexmedetomidine group compared to fentanyl group. Previous studies also found better surgical field with dexmedetomidine and they attributed this to hypotensive effect and quality of analgesia provided by dexmedetomidine. |