| CTRI Number |
CTRI/2016/10/007384 [Registered on: 20/10/2016] Trial Registered Retrospectively |
| Last Modified On: |
18/10/2016 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A clinical trial to evaluate the effect preoperative intranasal Dexmedetomidine to decrease hypertensive response of laryngoscopy and endotracheal intubation in elective lumber spine surgery. |
|
Scientific Title of Study
|
A randomized, double blinded, placebo controlled clinical trial to evaluate the efficacy of intranasal Dexmedetomidine as premedicant to attenuate haemodynamic response of laryngoscopy and intubation in elective lumber spine surgery. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ARKA DAS |
| Designation |
Post Graduate Trainee. |
| Affiliation |
I.P.G.M.E and R. Kolkata |
| Address |
224/4 Gorokshya Basi Road. Dum Dum. Kolkata-28
North Twentyfour Parganas
WEST BENGAL
700028
India |
| Phone |
9903368156 |
| Fax |
|
| Email |
doctor.arka@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SAIKAT NIYOGI |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
BANGUR INSTITUE OF NEUROSCIENCES |
| Address |
OMM TOWER, 4NO MM FEEDER ROAD,
BELGHORIA, KOLKATA
North Twentyfour Parganas
WEST BENGAL
700056
India |
| Phone |
9831732443 |
| Fax |
|
| Email |
saikatneuro1972@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
ARKA DAS |
| Designation |
Post Graduate Trainee. |
| Affiliation |
I.P.G.M.E and R. Kolkata |
| Address |
224/4 Gorokshya Basi Road. Dum Dum. Kolkata-28
North Twentyfour Parganas
WEST BENGAL
700028
India |
| Phone |
9903368156 |
| Fax |
|
| Email |
doctor.arka@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bangur Institute of Neurosciences, Kolkata. Debendra Lal Khan Rd, S S K M Hospital, Bhowanipore, Kolkata, West Bengal 700020 |
|
|
Primary Sponsor
|
| Name |
Bangur Institute of Neurosciences Kolkata |
| Address |
Debendra Lal Khan Rd, S S K M Hospital, Bhowanipore, Kolkata, West Bengal 700020 |
| 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 |
| DRSAIKAT NIYOGIASSOCIATE PROFESSOR |
Bangur Institute of Neurosciences, Neuroanesthesia department,Kolkata. |
52/1A,SAMBHUNATH PANDIT STREET,KOLKATA7000025
North Twentyfour Parganas
WEST BENGAL |
9831732443
saikatneuro1972@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of IPGMEandR, Kolkata |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
1. Preoperative anxiety and preoperative sedation.
2. Hemodynamic response to laryngoscopic surge and endotracheal intubation, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Diazepam, dexmedetomidinee |
Oral Diazepam at 0.2 mg/kg body weight given 90 mins before induction, intranasal dexmedetomidine at 1 mcg/kg given 45 mins before induction. |
| Intervention |
not applicable |
not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with ASA physical status I, patients having Mallampati I and II, patients with body mass index (BMI) < 30 kg/m2. |
|
| ExclusionCriteria |
| Details |
Patients refusal to participate in the study.Known allergy or hypersensitive reaction to dexmedetomidine or diazepam. Patients suffering from significant cardiac disease e.g IHD, cardiomyopathy, valvular disorder, hypertension, arrhythmia, etc. Patients suffering from significant respiratory disease e.g COPD, bronchial asthma, interstitial lung diseases, pneumonia etc. Patients having metabolic, endocrinal, musculoskeletal, neurologic disorder or having major congenital anomalies. History of drug abuse and/or psychiatric disorder. Pregnant women; no reliable contraceptive measures in postmenopausal women. Patients taking antihypertensive drugs such as methyldopa, clonidine and other α2 receptor agonists. Patients having morbid obesity, obstructive sleep apnoea, suspected difficult airway. Patients having liver and kidney dysfunction. Patients having long-term use of sedatives and analgesics. Patients having Mallampati grades III and IV. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Sedation and preoperative reduction in anxiety.
Heart Rate (variation of 10 beats/min) and Blood pressure variation to laryngoscopy and endotracheal intubation. |
Sedation and anxiety upto 45 mins before induction of General anaesthesia, hemodynamic variation from preinduction upto 10 mins after endotracheal intubation. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Any side effects including bradycardia and hypotension. |
during the whole study period. |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/03/2015 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
preparing for publication in national journal |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a randomized, double blinded placebo controlled trial comparing the safety and efficacy of Intranasal Dexmedetomidine (1 mcg/kg body weight) with Oral Daizepam (0.2 mg/kg body weight) versus intranasal placebo with Oral Diazepam ( 0.2 mg/kg body weight) only, in 70 adult patients undergoing elective lumbar spine surgery in 1 centre in India. The primary outcome measures are: 1. Preoperative reduction in anxiety and preoperative sedation, measured upto 45 minutes prior to induction of anaesthesia. 2. Hemodynamic response measured by Heart Rate and Blood pressure variation to laryngoscopy and endotracheal intubation measured upto 10 mins after intubation. |