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
|
|
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
|
|
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. |