| CTRI Number |
CTRI/2020/09/027630 [Registered on: 07/09/2020] Trial Registered Prospectively |
| Last Modified On: |
26/08/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare the effects of two different drugs(magnesium sulphate and dexmedetomidine) at reducing the blood pressure and heart rate during surgery for tumors of head and neck. |
|
Scientific Title of Study
|
Comparison of a single intravenous dose of magnesium sulphate or dexmedetomidine for attenuation of pressor response during selective neck dissection in head and neck malignancy:A double-blinded randomized interventional clinical trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr DIVYALAKSHMI S |
| Designation |
PG REGISTRAR |
| Affiliation |
Christian Medical College,Vellore |
| Address |
Department of Anaesthesia,
Christian Medical College,
IDA Scudder Road,
Vellore-632004
No,133 liq
Christian Medical College,
IDA Scudder Road,
Vellore-632004
Vellore
TAMIL NADU
632503
India |
| Phone |
7667756422 |
| Fax |
|
| Email |
divya231192@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr DIVYALAKSHMI S |
| Designation |
PG REGISTRAR |
| Affiliation |
Christian Medical College,Vellore |
| Address |
Department of Anaesthesia,
Christian Medical College,
IDA Scudder Road,
Vellore-632004
No,133 liq
Christian Medical College,
IDA Scudder Road,
Vellore-632004
Vellore
TAMIL NADU
632503
India |
| Phone |
7667756422 |
| Fax |
|
| Email |
divya231192@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tony Thomson Chandy |
| Designation |
Professor and head of unit 1 |
| Affiliation |
Christian Medical College,Vellore |
| Address |
Department of Anaesthesia,
Christian Medical College,
IDA Scudder Road,
Vellore-632004
Vellore
TAMIL NADU
632503
India |
| Phone |
9500242412 |
| Fax |
|
| Email |
tonythomson@cmcvellore.ac.in |
|
|
Source of Monetary or Material Support
|
| Christian Medical College,IDAcScudder Road,Vellore-632004,Tamilnadu. |
|
|
Primary Sponsor
|
| Name |
Christian Medical College |
| Address |
Christian Medical College,
IDA Scudder Road,Vellore,
Tamilnadu-632004 |
| 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 |
| Divyalakshmi S |
Christian Medical College |
Department of Anaesthesia,
IDA Scudder Road,Vellore,
Tamilnadu-632004
Vellore
TAMIL NADU |
7667756422
divya231192@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee silver,Office of Research,carman block,christian medical college,vellore,tamilnadu |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C148||Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
A bolus dose of Dexmedetomidine |
A single dose of Dexmedetomidine 0.5mcg/kg,over 10 minutes,via infusion pump |
| Intervention |
Bolus dose of Magnesium sulphate |
A single bolus dose of magnesium sulphate 30mg/kg,over 10 minutes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
All patients (ASA I and II) coming for selective neck dissection surgeries. |
|
| ExclusionCriteria |
| Details |
1.Patient refusal
2.ASA III and IV ,
3.GFR <90ml/mt/1.73m2
4.Patients on beta blockers and calcium channel blockers.
5.Known allergy to study drug
6.BMI >30
7.Vascular free flap surgery |
|
|
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 effect of a bolus of either magnesium sulphate or
dexmedetomidine on the hemodynamic response to surgical incision. |
Every five minutes from the time of infusion bolus dose |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) To compare the surgical field bleeding during neck dissection.
2) Comparison of duration of the attenuated pressor response..
3) Total intra-operative opioid requirements.
4) Additional medication required to attain normal pressures during neck dissection |
Calculated after the end of surgery. |
|
|
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
25/09/2020 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Primary tumour excision and selective neck dissection is the mainstay of treatment of oral cancers. The head and neck region is highly innervated and vascular and surgical stimulus causes an acceleration of the heart rate and blood pressure, resulting in increased bleeding and decreased visibility of the surgical field. Controlled hypotensive anaesthesia is an accepted method of providing a drier operative field, better visualization, more accurate dissection and reduced blood loss. Management of the intraoperative pressor response during surgical stimulus in head and neck surgeries continues to be a challenge. Inhalational anaesthetics combined with various intravenous agents are used to provide controlled hypotension during surgery. Various drugs have been used to reduce the pressor responses to noxious stimuli. Among these, the efficacy of dexmedetomidine, an α 2-adrenoreceptor agonist that reduces the heart rate and cardiac output, hence the blood pressure has been established. Magnesium Sulphate too reduces the blood pressure by inhibiting catecholamine release and arteriolar vasodilation. Studies comparing magnesium sulphate with dexmedetomidine shows conflicting conclusions of the advantage of one over the other. There are not many studies comparing the effect of these two drugs during selective neck dissection dissections. We would like to compare magnesium sulfate as a safe, effective and less expensive alternative to dexmedetomidine in our patient population undergoing head and neck surgery. Hence the need for this study. |