| CTRI Number |
CTRI/2013/05/003606 [Registered on: 03/05/2013] Trial Registered Retrospectively |
| Last Modified On: |
02/10/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
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Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
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Public Title of Study
|
This is a clinical study to find the ideal combination of anesthesia inducing agents (such as propofol, etomidate or thiopentone) with dexmedetomidine as a premedicant, for attenuation of adverse hemodynamic effects produced due to laryngoscopy and tracheal intubation. |
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Scientific Title of Study
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Comparison of hemodynamic response to laryngoscopy and tracheal intubation following combination of dexmedetomidine as premedicant with three different induction agents: propofol, etomidate and thiopentone |
| Trial Acronym |
|
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| NIL |
NIL |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR SASWATA BHARATI |
| Designation |
Assistant Professor |
| Affiliation |
Department of Anesthesia |
| Address |
Department of Anesthesia
Calcutta National Medical College
32, Gorachand Road
Kolkata
Kolkata
WEST BENGAL
700014
India |
| Phone |
|
| Fax |
|
| Email |
esbee77@gmail.com |
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Details of Contact Person
Scientific Query
|
| Name |
DR SASWATA BHARATI |
| Designation |
Assistant Professor |
| Affiliation |
|
| Address |
Department of Anesthesia
Calcutta National Medical College
32, Gorachand Road
Kolkata
WEST BENGAL
700014
India |
| Phone |
|
| Fax |
|
| Email |
esbee77@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SASWATA BHARATI |
| Designation |
Assistant Professor |
| Affiliation |
|
| Address |
Department of Anesthesia
Calcutta National Medical College
32, Gorachand Road
Kolkata
WEST BENGAL
700014
India |
| Phone |
|
| Fax |
|
| Email |
esbee77@gmail.com |
|
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Source of Monetary or Material Support
|
| Calcutta National Medical College and Hospital |
|
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Primary Sponsor
|
| Name |
Dr Saswata Bharati |
| Address |
Department of Anesthesia
Calcutta National Medical College
32, Gorachand Road,
KOlkata
PIN 700014 |
| Type of Sponsor |
Other [Individual; the principal investigator] |
|
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Details of Secondary Sponsor
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| Name |
Address |
| Prof Jatisankar Rudra |
Department of Anesthesia
Calcutta National Medical College
32, Gorachand Road,
KOlkata
PIN 700014 |
|
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Countries of Recruitment
|
India |
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Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Saswata Bharati |
Neurosurgical Operation Theatre |
Division of Neuroanesthesia
Department of Anesthesia
Calcutta National Medical College and Hospital
32, Gorachand Road,
Kolkata
PIN 700014
Kolkata
WEST BENGAL |
09474749014
esbee77@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Calcutta National Medical College |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients posted for different neurosurgical procedures, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
dexmedetomidine with etomidate |
Dexmedetomidine as premedicant: 1 microgram/kg of body weight over 10 minutes as bolus dose before the injection of induction agent followed by 0.5 microgram per kilogram of body weight per minute infusion until the laryngoscopy and intubation are completed and 10 minutes thereafter; and etomidate 0.3 mg/kg of body weight for induction of anesthesia
|
| Intervention |
dexmedetomidine with propofol |
Dexmedetomidine as premedicant: 1 microgram/kg of body weight over 10 minutes as bolus dose before the injection of induction agent followed by 0.5 microgram per kilogram of body weight per minute infusion until the laryngoscopy and intubation are completed and 10 minutes thereafter; and propofol 2 mg/kg of body weight for induction
|
| Comparator Agent |
dexmedetomidine with thiopentone |
Dexmedetomidine as premedicant: 1 microgram/kg of body weight over 10 minutes as bolus dose before the injection of induction agent followed by 0.5 microgram per kilogram of body weight per minute infusion until the laryngoscopy and intubation are completed and 10 minutes thereafter; and thiopentone 5 mg/kg of body weight for induction |
|
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Inclusion Criteria
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| Age From |
14.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade I and II patients, patients posted for various type of elective neurosurgery procedures |
|
| ExclusionCriteria |
| Details |
Patients with cardiac diseases, hypertension disorder, diabetes, hepatic or renal function disorder; Patients who have shown hypersensitivity to any of the drugs used in this study; Patients with CL grade 3 and 4; Patients who need intubation assistance other than using a Stylet; Patients who could not be intubated on single attempt; Patients with previous history of difficult intubation |
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
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Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
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Participant and Outcome Assessor Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| Mean blood pressure, heart rate |
Baseline before any medication
At 0 minute just before laryngoscopy
Then every 1 minute interval at 1 minute, 2 minute, 3 minute, 4 minute, 5 minute
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Mean blood pressure and heart rate |
10 minutes after the initiation of laryngoscopy |
|
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Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
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Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
30/03/2013 |
| 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="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
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Publication Details
|
None yet |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
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Laryngoscopy and tracheal intubation is particularly challenging in patients with raised intracranial pressure (ICP) as the resultant tachycardia and hypertension must be avoided to prevent further rise of intracranial pressure. The role of ideal combination of anesthetic drugs plays the key role in this. Various drugs have been tried in different combinations. However, an ideal combination of drugs for induction of anesthesia to perform laryngoscopy and tracheal intubation still to be found in neurosurgical patients with raised intracranial pressure. Dexmedetomidine is an alpha 2 agonist, a novel sedative with analgesic properties that controls stress, anxiety and pain. It decreases the level of stress hormones such as epinephrine, norepinephrine which are raised as a response to laryngoscopy and intubation. From various studies the attenuation of hemodynamic response to laryngoscopy and tracheal intubation by dexmedetomidine has been established. However, most of the studies documented this effect using single induction agent. For induction of anesthesia propofol, etomidate and thiopentone are the most commonly used three different induction agents. However each of them produces different cardiovascular effects when used alone or with other drugs such opioids or muscle relaxants. Therefore, it is no surprise that each of them will produce different cardiovascular effects when combined with dexmedetomidine for induction of anesthesia. This study will examine the cardiovascular response to laryngoscopy and tracheal intubation after combining dexmedetomidine with three different induction agents.
This is a prospective, double blinded, randomized study where 90 ASA grade I and II patients aged between 14 to 60 years who will be posted for various type of elective neurosurgery procedures in the neurosurgery operation theater of Calcutta National Medical College and Hospital, will be randomly allocated into three groups of 30 patients each namely group P, group E, and group T. The anesthetic agent for induction will be different for the groups. Patients of group P, group E and group T will be induced by propofol 2 mg/kg, etomidate 0.3 mg/kg and thiopentone 5 mg/kg respectively. Rest of the anesthetic procedure will be same for all the groups.
All the patients shall go through pre-anesthetic check-up. They will be fully explained about the nature of anesthesia and surgery. The patients will receive tablet alprazolam (0.25 mg for female and 0.5 mg for male patients) at the night before operation. Upon arrival in the operation theatre, they will be equipped with standard anesthesia monitoring viz. SpO2, NIBP, EtCO2, ECG, Temp (core), neuromuscular monitoring. CVP and IBP will be monitored in selective cases if required. Patients will be given injection (Inj) ondansetron (0.1 mg/kg) and Inj fentanyl (2 microg/kg) prior to dexmedetomidine infusion. Bolus dose of dexmedetomidine (1 µg/kg) will be infused over 10 minutes followed by maintenance (0.5 µg/kg/min) infusion. Patients will be given oxygen through face-mask. After the infusion of bolus dose of dexmedetomidine over 10 minutes, induction will be started. Patients will be induced by the different study drugs (i.e. thiopentone, etomidate, propofol) on a titration basis. Vecuronium (0.1 mg/kg) will be used as the muscle relaxant in all the patients. Patients will be assisted with bag and mask ventilation with 100% oxygen. The intubation procedure should start 3 min after the injection of vecuronium. Intubation shall be done with armored tube with stylet by an expert anesthetist with at least 2 years of experiences. The medication and observation of the study parameters will be done by separate anesthetists. Anesthesia will be maintained using N2O, O2, and propofol infusion or isoflurane.
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