| CTRI Number |
CTRI/2023/12/060514 [Registered on: 18/12/2023] Trial Registered Prospectively |
| Last Modified On: |
18/12/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of three different doses of a drug, dexmedetomidine for prevention of an increase in heart rate and blood pressure as a response to laryngoscopy and intubation by assessment of haemodynamic parameters and plasma catecholamine levels by maintaining adequate depth of anesthesia |
|
Scientific Title of Study
|
Comparison of three different doses of dexmedetomidine for attenuation of the pressor response to laryngoscopy and intubation by assessment of hemodynamic parameters and plasma catecholamine levels under Bi Spectral index guided anaesthesia - A prospective randomized controlled study. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Michell Gulabani |
| Designation |
Associate Professor Anaesthesia |
| Affiliation |
University College of Medical Sciences/Guru Tegh Bahadur Hospital |
| Address |
University College of Medical Sciences.
Guru Tegh Bahadur Hospital,
Delhi, Shahdara
Department of Anaesthesia
Second floor, Near Main ICU
Room no 201
University College of Medical Sciences.
Guru Tegh Bahadur Hospital,
Delhi, Shahdara
Department of Anaesthesia
Second floor, Near Main ICU
Room no 201
East
DELHI
110017
India |
| Phone |
09873657500 |
| Fax |
9873657500 |
| Email |
michellgulabani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Michell Gulabani |
| Designation |
Associate Professor Anaesthesia |
| Affiliation |
University College of Medical Sciences/Guru Tegh Bahadur Hospital |
| Address |
University College of Medical Sciences.
Guru Tegh Bahadur Hospital,
Delhi, Shahdara
Department of Anaesthesia
Second floor, Near Main ICU
Room no 201
University College of Medical Sciences.
Guru Tegh Bahadur Hospital,
Delhi, Shahdara
Department of Anaesthesia
Second floor, Near Main ICU
Room no 201
DELHI
110017
India |
| Phone |
09873657500 |
| Fax |
9873657500 |
| Email |
michellgulabani@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Michell Gulabani |
| Designation |
Associate Professor Anaesthesia |
| Affiliation |
University College of Medical Sciences/Guru Tegh Bahadur Hospital |
| Address |
University College of Medical Sciences.
Guru Tegh Bahadur Hospital,
Delhi, Shahdara
Department of Anaesthesia
Second floor, Near Main ICU
Room no 201
University College of Medical Sciences.
Guru Tegh Bahadur Hospital,
Delhi, Shahdara
Department of Anaesthesia
Second floor, Near Main ICU
Room no 201
DELHI
110017
India |
| Phone |
09873657500 |
| Fax |
9873657500 |
| Email |
michellgulabani@gmail.com |
|
|
Source of Monetary or Material Support
|
| local research advisory committee (LRAC) of Medical Research Unit(MRU) for execution at MRU-University College of Medical Sciences (UCMS).
Guru Tegh Bhadur Hospital, Shahdara |
|
|
Primary Sponsor
|
| Name |
Medical Research Unit of University College of Medical Sciences as an intramural grant |
| Address |
Shahdara New Delhi |
| Type of Sponsor |
Government medical college |
|
|
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 Michell Gulabani |
University College of Medical Sciences/Guru Tegh Bahadur Hospital |
Department of Anesthesia
Guru Tegh Bahadur Hospital Delhi
East
DELHI |
09873657500
9873657500
michellgulabani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics comm Institutional Ethics Committee- Human Research, University College of Medical Sciences, Shahdaraitte human resources, University College Of Medical Sciences, Shahdara |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Dexmedetomidine in three different doses for attenuation of pressor response to laryngoscopy and intubation |
Group D1 - Patients will be given IV Dexmedetomidine loading dose 0.5ug/kg diluted in normal saline up to 50 ml over 10 minutes prior to induction.
|
| Intervention |
Dexmedetomidine in three different doses for attenuation of pressor response to laryngoscopy and intubation |
Group D1 - Patients will be given IV Dexmedetomidine loading dose 0.5ug/kg diluted in normal saline up to 50 ml over 10 minutes prior to induction.
Group D2- Patients were given IV Dexmedetomidine loading dose 0.75ug/kg diluted in normal saline up to 50 ml over 10 minutes prior to induction.
Group D3- Patients will be given IV Dexmedetomidine loading dose 1ug/kg diluted in normal saline up to 50 ml over 10 minutes prior to induction.
|
| Comparator Agent |
Dexmedetomidine in three different doses for attenuation of pressor response to laryngoscopy and intubation |
Patients were given IV Dexmedetomidine loading dose 0.75ug/kg diluted in normal saline up to 50 ml over 10 minutes prior to induction. |
| Comparator Agent |
Dexmedetomidine in three different doses for attenuation of pressor response to laryngoscopy and intubation |
Patients will be given IV Dexmedetomidine loading dose 1ug/kg diluted in normal saline up to 50 ml over 10 minutes prior to induction. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
All ASA I and II patients, aged 18-60 years, scheduled for elective surgery under general anesthesia.
In the preoperative area, an 18 G intravenous cannula will be inserted and venous blood sample for plasma adrenaline and nor-adrenaline will be drawn for the first time. Subsequently, a ringer lactate drip at the rate of 8-10ml/kg per hour for all the study patients will be ensured.
On shifting the patient to the OR, all standard monitors including non invasive blood pressure (NIBP), oxygen saturation probe, electrocardiogram and BIS electrodes on the forehead will be applied. The baseline parameters [Ta] including heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), mean blood pressure (MBP), oxygen saturation (SPo2), BIS and MOAS will be recorded.
Subsequently infusion of the study drug, which will be prepared by an independent observer who will not be involved in the study will be initiated and continued as an infusion over 10 minutes. During infusion of study drug if the oxygen saturation drops below 95%, then oxygen will be supplemented by a simple face mask at the rate of 5-6 litres/minute.
On completion of the study drug, all the parameters [Tb] will be recorded again and noted in the record sheet. Anaesthesia will be induced with Inj Propofol 2mg/kg and Inj Fentanly 2ug/kg. After, the loss of response to verbal commands (end point of induction), all the study parameters will be recorded [Tc] and BIS will be maintained between 40-60 with help of titration of propofol and inhalational agent sevoflurane. The total dose of propofol required for induction shall be noted in all the study groups.
After checking the adequacy of mask ventilation, Inj Vecuronium bromide 0.1 mg/kg I/V will be administered and at the end of 3 minutes, just before performing laryngoscopy, all parameters [Td] will be noted. A senior anesthesiologist will perform the laryngoscopy and intubation with an appropriate size endotracheal tube (ETT). The study parameters will be recorded at 1 minute [Te], 2 minutes [Tf], 3 minutes [Tg], 5 minutes [Th] and 7 minutes [Ti] after intubation in all three study groups. Anaesthesia will be maintained with oxygen: nitrous oxide in 50:50 % combination at flow of 2 litres per minute with sevoflurane and BIS will kept at all time intervals between 40-60. At time Tg, the venous blood sample for plasma adrenaline and nor-adrenaline will also be drawn for a second time. After the last recording of the study parameters, ie Ti the study will be complete.
|
|
| ExclusionCriteria |
| Details |
Patients with a history of pulmonary disease like COPD, asthma, pregnancy, morbid obesity, diabetes mellitus (HbA1c > 6.5%), uncontrolled hypertension, impaired kidney or liver function, progressive neurological disease and bleeding diathesis, anticipated difficult airway, time taken for laryngoscopy and intubation exceeding more than 15 seconds, more than one attempt made for laryngoscopy and endotracheal intubation will be excluded from this study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. To study and compare the change in heart rate and systolic blood pressure (SBP) after administration of dexmedetomidine in all the three groups at different time intervals, maintaining BIS values between 40-60. |
1. To study and compare the change in heart rate and systolic blood pressure (SBP) after administration of dexmedetomidine in all the three groups at different time intervals, that is baseline, after completion of study drug, after induction, just before laryngoscopy, 1 minute after intubation, 3 minutes after intubation, 5 minutes after intubation and 7 minutes after intubation, maintaining BIS values between 40-60. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To study and compare the change in plasma adrenaline and nor-adrenaline levels following administration of three different doses of dexmedetomidine prior to laryngoscopy and intubation
2. To determine the change in the Modified Observer’s Assessment of Alertness/Sedation (MOAS) Scale recorded at baseline (before) the administration of dexmedetomidine and after its completion (10 minutes) in all the three study groups.
3. To determine the incidence of perioperative complications including hypotension (>20% fall in blood pressure from baseline) and bradycardia (heart rate<60 beats/minute) or desaturation (oxygen saturation<95%) in any of the study groups at different time intervals.
4. To determine the total requirement for propofol dose for anaesthesia induction in the three study groups, maintaining BIS values between 40-60.
|
baeline and 3 minutes after intubation |
|
|
Target Sample Size
|
Total Sample Size="168"
Sample Size from India="168"
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)
|
30/12/2023 |
| 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="0"
Months="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Laryngoscopy and intubation are noxious stimuli which evoke a plethora of undesirable effects like tachycardia, hypertension and cardiac dysrhythmias with an increase in plasma catecholamine levels which can be life threatening for patients with underlying cardiac comorbidities. Monitoring the depth of anaesthesia by Bi Spectral Index is vital in to prevent hypertension and tachycardia. A variety of pharmacological methods have been utilized for the attenuation of pressor response which include lignocaine, beta blockers, calcium channel blockers, opioids and dexmedetomidine. Dexmedetomidine has been compared with other agents in different doses ranging from 0.5μg/kg to 1μg/kg with varied results. In most of the studies on dexmedetomidine available in literature, the depth of anaesthesia and plasma catecholamine levels have never been studied in the context of obtaining an optimal dose. Hence, this study will be planned using three different doses of dexmedtomidine namely 0.5 μg/kg, 0.75μg/kg, and 1 μg/kg in patients undergoing elective surgeries under general anaesthesia for attenuation of the pressor response by maintaining adequate depth of anaesthesia. The primary objective will be to study and compare the change in heart rate and systolic blood pressure after administration of dexmedetomidine at different time intervals, maintaining adequate anaesthetic depth . Also, to study and compare the change in plasma adrenaline and nor-adrenaline levels following administration of three different doses of dexmedetomidine prior to laryngoscopy and intubation. This study will be carried out as a prospective, randomized, double blinded research project after approval by the Hospital Ethics committee, in 168 consenting adult patients aged 18-60 years of either sex, ASA Grade I & II undergoing elective surgery under general anesthesia with endotracheal intubation. The patients will then be randomly distributed in one of the three study groups (50 patients each) by a computer generated random number table and allocation concealment will be performed by opaque sealed envelopes. Group D1, Group D2 and Group D3 - Patients will be given IV Dexmedetomidine loading dose 0.5ug/kg, 0.75ug/kg and 1ug/kg diluted in normal saline up to 50 ml over 10 minutes prior to induction. Expected Outcomes To obtain the dose of dexmedetomidine which will effectively attenuate the pressor response, with confirmation by plasma catecholamine levels while maintaining adequate depth of anaesthesia and also avoiding the known side effects associated with a higher dose. |