| CTRI Number |
CTRI/2020/07/026325 [Registered on: 02/07/2020] Trial Registered Prospectively |
| Last Modified On: |
24/06/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A study to evaluate the effect of dexmedetomidine on blood pressure and heart rate of patients during a surgical procedure where pins are drilled inside the skull while removing a part of it. |
|
Scientific Title of Study
|
The effect of dexmedetomidine vs placebo on haemodynamic response to skull pin insertion in patients undergoing craniotomy:a randomised blinded comparative 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 Nandini Phukan |
| Designation |
Postgraduate trainee |
| Affiliation |
Gauhati Medical College and Hospital |
| Address |
Department of Anaesthesiology and Critical Care,Gauhati Medical College and Hospital,Bhangagarh,Guwahati,Kamrup
Bhangagarh,Guwahati,Kamrup,PIN 781032.
Kamrup
ASSAM
781032
India |
| Phone |
8876948508 |
| Fax |
|
| Email |
nandiniphukan91@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Faiza Ahmed Talukdar |
| Designation |
Prof and Head of Department |
| Affiliation |
Gauhati Medical College and Hospital |
| Address |
Department of Anaesthesiology and Critical Care,Gauhati Medical College and Hospital,Bhangagarh,Guwahati,Kamrup
Bhangagarh,Guwahati,Kamrup,PIN 781032.
Kamrup
ASSAM
781032
India |
| Phone |
9864031429 |
| Fax |
|
| Email |
faizaahmedtalukdar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nandini Phukan |
| Designation |
Postgraduate trainee |
| Affiliation |
Gauhati Medical College and Hospital |
| Address |
Department of Anaesthesiology and Critical Care,Gauhati Medical College and Hospital,Bhangagarh,Guwahati,Kamrup
Bhangagarh,Guwahati,Kamrup,PIN 781032.
Kamrup
ASSAM
781032
India |
| Phone |
8876948508 |
| Fax |
|
| Email |
nandiniphukan91@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Nandini Phukan,Dept of Anaesthesiology,Gauhati Medical College and Hospital,Bhangagarh,Guwahati,Kamrup,Assam |
|
|
Primary Sponsor
|
| Name |
Dr Nandini Phukan |
| Address |
Department of Anaesthesiology and Critical Care ,Gauhati Medical College and Hospital,Bhangagarh,Guwahati,Kamrup,Assam |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Faiza Ahmed Talukdar |
Professor and Head,Department of Anaesthesiology and Critical Care,Gauhati Medical College and Hospital,Bhangagarh,Guwahati 781032,Kamrup,Assam |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nandini Phukan |
Neurosurgery Operation Theatre,Third floor,Dept of Neurosurgery,GMCH |
Gauhati Medical College and Hospital,Bhangagrh,Guwahati 781032
Kamrup
ASSAM |
8876948508
nandiniphukan91@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituional Ethics Committee,Gauhati Medical College and Hospital. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R098||Other specified symptoms and signsinvolving the circulatory and respiratory systems, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexmedetomidine Hydrochloride |
Inj dexmedetomidine hydrochloride at the dose of 1microgram per kg bodyweight given intravenous using a syringe pump over 10 mins before induction of anaesthesia |
| Comparator Agent |
Placebo(Sodium chloride 0.9%) |
Placebo(Inj Sodium chloride 0.9%),volume matched with the intervention agent given intravenous using a syringe pump over 10 mins before induction of anaesthesia. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.ASA I and II
2.Elective surgery
3.Pre operative GCS 15
4.Patients giving valid consent |
|
| ExclusionCriteria |
| Details |
1.Pre operative heart rate less than 45
2.Pregnancy
3.Known allergy to dexmedetomidine
4.Second or third degree haeart block
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the effect of iv inj dexmedetomidine in attenuating the haemodynamic response(SBP,DBP,MAP,HR) to skull pin holder application during craniotomy |
At the time of pin insertion,1,5,10,15 mins after pin insertion |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To determine the effect of iv inj dexmedetomidine in attenuating the haemodynamic response(SBP,DBP,MAP,HR) during laryngoscopy and intubation
|
After giving drug or placebo,after intubation
|
| To compare the plasma glucose level before and after pin insertion |
15 mins before the administration of inj dexmedetomidine or placebo(baseline) and 30 and 60 mins after pin insertion |
|
|
Target Sample Size
|
Total Sample Size="82"
Sample Size from India="82"
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)
|
20/07/2020 |
| 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
|
It will be sent for publication in peer reviewed journal after study is complete. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The Mayfield skull pin head holder is used to stabilise the head during neurosurgical procedures.When applied properly,the pins cause considerable periosteal stimulation which results in abrupt increase in Mean Arterial Pressure and cerebral blood flow under general anaesthesia.The haemodynamic responses may lead to brain oedema,increase in ICP or ICH.(1) The stress response to a nociceptive stimulus is characterised by increased secretion of pituitary hormones and activation of sympathetic system.(1,2) A number of anaesthetic techniques have been used to obtund the deleterious effects,among which dexmedetomidine is found to be superior.(3,4).Dexmedetomidine is a highly specific,potent and selective alpha 2 agonist.It has analgesic,sedative and anaesthesia sparing effects and it decreases the MAP,HR and sympathetic nervous system in dose dependent fashion.(1). Altough dexmedetomodine is widely used in our setup,but its use in obtunding the above mentioned deleterious effects is not studied in our population yet.In this randomised controlled study,the null hypothesis that dexmedetomidine doesn’t reduce MAP and HR will be investigated.We will primarily try to compare the effect between iv inj dexmedetomidine given iv at the dose of 1microgram per kg bodyweight over 10 mins before induction of anaesthesia and placebo(inj sodium chloride0.9%) given iv over 10 mins before the induction of anaesthesia on attenuating the SBP,DBP,MAP and HR at the time of pin insertion,1,5,10,15mins after pin insertion .Secondarily we will try to see (a) the effect of inj dexmedetomodine in attenuating haemodynamic response(SBP,DBP,MAP and HR) during laryngoscopy and intubation (b) compare the plasma glucose level before and after pin insertion REFERENCES: (1)Renganathan T,Venkatesan G.Comparative study to evaluate the effect of dexmedetomidine in attenuating the haemodynamic and neuroendocrine responses to skull pin holder application during craniotomy.J.Evid.Based Med.Heathc.2017;4(31):1814-1819. (2)Desborough JP.The stress response to trauma and surgery.Br J Anaesthesia.2000 Jul;85:109-117 (3)Paul A,Krishna HM.Comparison between intravenous dexmedetomidine and local lignocaine infiltration to attenuate the haemodynamic response to skull pin head holder application during craniotomy.Indian J Anaesthesia.2015;59(12):785-788 (4)Thongrong C,Sirikannarat P,Kasemsiri P,Duangthongphon P.Comparison of dexmedetomidine and fentanyl to prevent haemodynamic response to skull pin application in neurosurgery:double blind randomized controlled trial.Anaesthesiology Intensive Therapy.2017;49(4):268-73 |