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CTRI Number  CTRI/2013/08/003885 [Registered on: 08/08/2013] Trial Registered Retrospectively
Last Modified On: 02/08/2013
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 study the effects of dexmedetomidine drug on laryngoscopy and tracheal intubation during the administration of general anesthesia. 
Scientific Title of Study   A clinical study to evaluate the role of preoperative dexmedetomidine on attenuation of haemodynamic response to direct laryngoscopy and tracheal intubation 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR SATINDER GOMBAR 
Designation  Professor and Head 
Affiliation  Govt. Medical College and Hospital, Chandigarh 
Address  Department of Anaesthesia and Intensive Care,Level 5, D block Govt. Medical College and Hospital Sector 32, Chandigarh
Govt. Medical College and Hospital, Sector 32, Chandigarh
Chandigarh
CHANDIGARH
160030
India 
Phone  91-9646121520  
Fax  91-172-2609360  
Email  dr_sgombar@rediffmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR DHEERAJ KAPOOR 
Designation  Assistant Professor 
Affiliation  Govt. Medical College and Hospital, Chandigarh 
Address  Department of Anaesthesia and Intensive Care,Level 5, D block Govt. Medical College and Hospital
Govt. Medical College and Hospital, Sector 32, Chandigarh
Chandigarh
CHANDIGARH
160030
India 
Phone  91-9646121549  
Fax  91-172-2609360  
Email  kapoor.dheeraj72@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR KAMLESH KUMARI 
Designation  POST GRADUATE TRAINEE 
Affiliation  Govt. Medical College and Hospital, Chandigarh 
Address  Department of Anaesthesia and Intensive Care,Level 5, D block Govt. Medical College and Hospital
Govt. Medical College and Hospital, Sector 32, Chandigarh
Chandigarh
CHANDIGARH
160030
India 
Phone  91-9780040150  
Fax  91-172-2609360  
Email  kamlesh.gmch@gmail.com  
 
Source of Monetary or Material Support  
Govt medical college and hospital Sector 32, Chandigarh 
 
Primary Sponsor  
Name  Govt Medical College and Hospital Sector Chandigarh 
Address  Govt. Medical College and Hospital Sector 32, Chandigarh  
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Satinder Gombar  Govt. Medical College and Hospital Sector 32, Chandigarh  Department of Anaesthesia and Intensive care,Level 5, D block Govt. medical college and hospital Sector 32, Chandigarh
Chandigarh
CHANDIGARH 
91-9646121520
91-172-2609360
dr_sgombar@rediffmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics committee, Government Medical College, Chandigarh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  SURGERY 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Dexmedetomidine  Dexmedetomidine, an imidazole compound, is the pharmacologically active dextroisomer of medetomidine that displays specific and selective α2-adrenoceptor agonism. It produce analgesia, sedation, and anxiolysis. Patients in this group received, dexmedetomidine 0.5µgkg-1 via intravenous (IV) route, to a total volume of 20 ml over 10 min.  
Comparator Agent  Placebo (Normal Saline)  The placebo used in this trial is 0.9% normal saline.Patients in this group received, 0.9% saline via intravenous (IV) route, to a total volume of 20 ml over 10 min. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.80 adult patients of ASA (American Society of Anesthesiologists) physical status I /II of either sex
2.Age group of 18 to 60 years
3.Scheduled to undergo elective surgery under general anaesthesia requiring endotracheal intubation 
 
ExclusionCriteria 
Details  The following categories of patients were excluded from the study:
1. ASA grade III or more
2. Anticipated difficult airway
3. BMI >30 kg m 2
4. Preoperative medication with clonidine or alphamethyldopa
5. Hiatus hernia, gastroesophageal reflux
6. Known allergy to dexmedetomidine
7. Known case of coronary artery disease 
 
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 study the effect of dexmedetomidine given before induction of anaesthesia on haemodynamic responses to direct laryngoscopy and tracheal intubation.  Heart Rate (HR), Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), Mean Blood Pressure (MBP), Oxygen Saturation (SpO2), end tidal CO2 (EtCO2) were continuously monitored and recorded at following time intervals.
- Baseline
- After completion of infusion of study drug
- 5 min after completion of infusion of study drug
- After induction
- Just before intubation
- After intubation at 1min, 3min, 5min, 10min and 15 min.
 
 
Secondary Outcome  
Outcome  TimePoints 
1)To study effect of dexmedetomidine on requirement of propofol at induction.
2)To study the adverse effects of dexmedetomidine.
 
- After recording the primary outcome observations for 15 the rest of the anaesthetic procedure was carried out. The secondary outcomes were recorded during the study which includes the the total dose of propofol required for induction and any adverse effects of dexmedetomidine during the entire study was recorded.  
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   05/10/2011 
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   Not yet published. 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

After approval of protocol by Institutional Ethics Committee and written informed consent, 80 adult patients of ASA (American Society of Anesthesiologists) physical status I /II of either sex, in the age group of 18 to 60 years who were scheduled to undergo elective surgery under general anaesthesia requiring tracheal intubation were included in the study. Using computer generated number table, patients were randomly divided into two groups of 40 each. Patients were allocated to one of the following group using sequentially numbered, sealed, opaque envelopes. Group I patients received dexmedetomidine, 0.5 microgram per kg i.v over 10 min and Group II patients received an equal volume of normal saline i.v over 10 min. After intubation anaesthesia was maintained with 33% of O2, 67% N2O and propofol infusion @ 50-80 microgram/kg/min. Heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), mean blood pressure (MBP), oxygen saturation (SpO2) , end tidal carbon dioxide (EtCO2) were continuously monitored and recorded at baseline, after completion of infusion of study drug, 5 min after completion of infusion of study drug, after induction, just before intubation, after intubation at 1 min, 3 min, 5 min, 10 min and 15 min. After recording the observations for 15 minutes, the rest of the anaesthetic procedure was carried out at the discretion of the attending anaesthesiologist. During study, the total dose of propofol required for induction was recorded. The side effects of the study drugs, if any, were also recorded. All the observations were recorded in the proforma attached and analyzed statistically using appropriate statistical test. Normality of data were checked by measures of skewness and kolmogorov smirnov tests. For normally distributed data students t- tests and for skewed data Mann Whitney U tests was applied for two groups. For time dependent changes, repeated measure ANOVA was applied. Data was presented as mean+-SD with p<.05 as significant.


 
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