| CTRI Number |
CTRI/2022/11/047639 [Registered on: 24/11/2022] Trial Registered Prospectively |
| Last Modified On: |
22/11/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Effects of three different medicines for prevention of vomiting after surgery |
|
Scientific Title of Study
|
A randomized control study on effects of Dexmedetomidine, Magnesium sulphate and Propofol in middle ear surgeries |
| Trial Acronym |
DexMag |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Maria Stany |
| Designation |
1st year PG resident |
| Affiliation |
St.Johns Medical College |
| Address |
PG Resident
Department of Anaesthesia
St Johns Medical College and Hospital
Bengaluru
Bangalore
KARNATAKA
560034
India |
| Phone |
9447323248 |
| Fax |
|
| Email |
mariastany100@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Maria Stany |
| Designation |
1st year PG resident |
| Affiliation |
St.Johns Medical College |
| Address |
PG Resident
Department of Anaesthesia
St Johns Medical College and Hospital
Bengaluru
Bangalore
KARNATAKA
560034
India |
| Phone |
9447323248 |
| Fax |
|
| Email |
mariastany100@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrMManjuladevi |
| Designation |
Professor |
| Affiliation |
St Johns Medical College and Hospital |
| Address |
Professor
Department of Anaesthesia
St Johns Medical College and Hospital
Bengaluru
Bangalore
KARNATAKA
560034
India |
| Phone |
9449059395 |
| Fax |
|
| Email |
drmanjula95@yahoo.com |
|
|
Source of Monetary or Material Support
|
| St Johns Medical College and Hospital
sarjapura road
Kormangala
Bengaluru 560034 |
|
|
Primary Sponsor
|
| Name |
St Johns Medical College and Hospital |
| Address |
St.Johns Medical College and Hospital
Sarjapur Road,
Bengaluru
PIN -560034 |
| 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 |
| Maria Stany |
St. Johns Medical College and Hospital |
Room no.9
2 nd floor operation theatre complex
St.Johns Medical College Hospital
Sarjapur Road , Kormangala
Bengaluru, 560034,Karnataka, India
Bangalore
KARNATAKA |
9447323248
mariastany100@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H712||Cholesteatoma of mastoid, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Intraoperative use of Propofol |
Patients in Group are given Propofol as a boluses over 15 minutes followed by 6mg/kg/hr infusion before the time of incision,and then by 4mg/kg/hr till the microscope used for surgery is taken off. |
| Intervention |
Introperative use of Dexmedetomidine and Magnesium |
Patients in Group D will be given Dexmedetomidine bolus iv of 1 mcg/kg in 100 ml NS over 15 minutes before incision is made .This will be followed by infusion of 0.3mcg/kg/hr during the surgery.
Patients in Group M(Magnesium sulphate) will be given Magnesium sulphate iv bolus of 30mg/kg in 100 ml NS over 15 mins followed by infusion of 10 mg/kg/hr during the surgery
infusions are used until the microscope is taken off . |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
59.00 Year(s) |
| Gender |
Both |
| Details |
1)Adults aged 18-59 years posted for middle ear surgeries.
2)ASA 1 and 2 patients with well controlled co-morbidities |
|
| ExclusionCriteria |
| Details |
1)Patients already on chronic analgesic medications
2)Obese patients BMI>30
3)Pregnant patients
4)Patients with h/o motion sickness,reflux and previous h/o post operative nausea , vomitting |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of intraoperative use of Propofol, Dexmedetomidine and Magnesium sulphate for controlled hypotension (MAP of 55-65 mmHg) in middle ear surgeries |
At 5,10,15,20,30,45,60,78,90,105 and 120 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess oligemic field during the surgery.
To compare the anaesthetic agent consumption (Oxygen, Air and Isoflurane ) at the end of the surgery.
To compare the degree of postoperative pain and postoperative nausea and vomiting after Propofol , Dexmedetomidine and Magnesium sulphate in recovery period at 5 minutes, 30 minutes, 1 hour, 2hours and 8 hours.
|
A)Oligemic field and anaesthetic agent at the end of surgery
B) Post operative nausea and vomiting and post operative pain at early(5min,30 min) and late (1 hour , 2 hours and 8 hours) |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/12/2022 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet from this trial |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a randomized control study and aims to compare the effects of Propofol , Dexmedetomidine and Magnesium sulphate in middle ear surgeries .Primary objectives of the study is to compare the efficacy of intraoperative use of Propofol , Dexmedetomidine and Magnesium sulphate for controlled hypotension (MAP of 55-65 mmHg) in middle ear surgeries. The secondary objective is to assess oligemic field during the surgery , to compare the anaesthetic agent consumption (oxygen, air and isoflurane) at the end of the surgery , to compare the degree of postoperative pain and postoperative nausea and vomiting.The recruited patients will be randomized and allocated into one of the three groups-Group P(Propofol),Group M(Magnesium sulphate) and Group D(Dexmedetomidine) by a computer generated table.The study drugs will be given as a boluses over 15 minutes(Propofol 6mg/kg/hr, Dexmedetomidine 1mcg/kg in 100mL NS, Magnesium sulphate 30mg/kg in 100 mL NS) before the time of incision, followed by and infusion( Propofol 4mg/kg,Dexmedetomidine 0.3mcg/kg/hr,Magnesium sulphate 10mg/kg/hr) till the microscope used for surgery is taken off. The outcome variables and their measures: 1)Intraoperative haemodynamics at 5,10,15,20,30,45,60,78,90,105 and 120 minutes respectively 2)Oligemic field as assessed by the surgeon at the end of the surgery 3) Anaesthetic agent consumption at the end of the surgery 4)Post operative nausea and vomiting, Post operative pain – Early ( 5 minutes, 30 minutes, 1 hour ) and late ( 2 hours and 8 hours) Descriptive and inferential statistical analysis will be done .Results on continuous measurements are presented as Mean +/- SD.Results on categorical measurements are presented as number %.Analysis of variance (ANOVA) will be used to find the significance of study parameters between three groups of patients. Student t test will be used to find the significance of study parameters within each group.Chi square/ Fisher exact test will be used to find the significance of study parameters on categorical scale between two groups. |