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Dexmedetomidine Report

In: Science

Submitted By SONIL
Words 2606
Pages 11
| | Prepared by:
SHRUTI GULATI | | | | | |
DEXELEX

To assess the existing clinical practice of INTENSIVISTS & ANAESTHESIOLOGISTS for the management of sedation and analgesia while taken into consideration “dexmedetomidine”

ACKNOWLEDGEMENT

I would like to express my sincere gratitude towards RANBAXY Laboratories Limited, Mumbai for selecting me as a summer trainee and giving me an opportunity to work on this project and also for providing a good working ambience for successful completion of this project.
I also thank the MARKETING RESEARCH TEAM for giving me an opportunity to conduct market research for DEXELEX belonging to INTENSIVA division of RANBAXY. I would like to express my special gratitude towards my guide Mr. Shoreb Khanduri, who throughout my project has been teacher and supporter for me showing me the right direction during my project.

I am highly grateful to all summer interns and friends for their support and cooperation, owing to which I have successfully completed and compiled this report

Last but not least, I would like to express my sincere thanks to my institute NIPER for providing me all kind of support in my summer project placement at RANBAXY Laboratories Limited.

Shruti Gulati

Certificate

This is to certify that the dissertation submitted in partial fulfillment for the degree of M.B.A. in Pharmaceutical Management of National Institute of Pharmaceutical Education and Research (NIPER) is a result of the bonafide research work carried out by Ms. SHRUTI GULATI under my supervision and guidance, no part of this report has been submitted for award of any other degree, diploma, fellowship or other similar titles or prizes. The work has also not been published in any journals/Magazines.

Project Guides: Mr. SHOREB KANDURI (Group Brand Manager INTENSIVA DIVISION)
Mr. MALVINDER SINGH (Marketing Research Deptt.)
Mr. S. T. KALAIRAJ (Sr. Manager Marketing Research Deptt.)

ABSTRACT

Table of Contents

* 4-((S)-alpha,2,3-Trimethylbenzyl) imidazole * Dexmedetomidine hydrochloride is the S-enantiomer of medetomidine and is chemically described as: (+)-4-(S)-[1-(2,3-dimethylphenyl)ethyl]-1H-imidazole monohydrochloride. * Molecular formula : C13H16N2.HCl * Molecular Weight : 236.74 * Introduced 1999 ( Precedex®, Hospira) * Approved for short term sedation by FDA * Selective α2 receptor agonist. (2:1 1620:1) * Provides – Sedation, Anxiolysis, Analgesia * No respiratory depression * Mild antihypertensive effects * Decrease the need for other analgesic medications such as opioids * Rapid redistribution: 6 min * Elimination half-life: 2 h * Protein binding: 94% * Metabolism: biotransformation in liver to inactive metabolites + excreted in urine * No accumulation after infusions 12-24 h * Pharmacokinetics similar in young adults elderly * Intravenous: * Distribution t1/2 = 6 minutes * Elimination t1/2 = 2 hrs * Intramuscular (2ug/kg): * Peak plasma conc 13±18 min (variable) 70% bioavailability * Enteral: * Buccal - 80% bioavailability * Gastric - 16-20% bioavailability * Almost 100% biotransformation * Glucuronidation * Cytochrome P450 mediated * Metabolites all inactive – urinary elimination * Significant t1/2 in hepatic failure (7.5 hr) * <1% excreted as unchanged * No significant effect of renal impairment Ca++
Ca++
Ca++


+
Decrease in influx of Ca++ Decrease in action potential due to hyperpolarization a2A a2AR Go
Gk
K+
K+
K+

Types 1. General anaesthesia 2. Regional anaesthesia 3. Monitored anaesthesia care (MAC)

Anaesthesia Drugs 1. General Anaesthesia Agents : Propofol , Thiopentone, Isoflurane 2. Local Anaesthetic Agents : Bupivacaine, Lignocaine 3. Anaesthetic Adjuncts : Benzodiazepines : Midazolam, Diazepam, Lorazepam Alpha 2 Adrenergic Agonist : Dexmedetomidine, Clonidine Analgesics : Fentanyl, Morphine, Pethidine, NSAIDS
4. Neuro muscular blocking agents : Vecuronium , Pancuronium
5. Sedatives : benzodiazepines , dexmedetomidine
Commonly used sedatives I. Benzodiazepines – Midazolam, Lorazepam,Diazepam II. Anaesthetics- Propofol III. Central alpha agonist-Clonidine,Dexmedetomidine IV. High dose opioid-morphine V. Others-Haloperidol

Research objectives
Primary Objective To assess the existing clinical practice of INTENSIVISTS & ANAESTHESIOLOGISTS for the management of sedation and analgesia while taken into consideration “dexmedetomidine”

Secondary objective :
1. To analyse the existing awareness and knowledge of Dexmedetomidine molecule among various specialists 2. To find out the important parameters to be considered for ICU sedation by Intensivists/anaesthesiologist and the drugs they prefer to manage these parameters

3. To analyse the specific drugs used for sedation by anaesthesiologists for different types of surgeries

4. To find out the role of sedatives during Peri-Operative procedures

Research methodology
Research Plan : Data source : Primary and Secondary research Research approach : Sample size -183 Cities covered-8 Research tools : Questionnaire containing both open ended and closed questions , separate both for Anaesthesiologist and Intensivists
Type of interview : One to One Interviewing Method with Intensivists and Anaesthesiologists
Type of Research : Exploratory research

.

INTENSIVISTS SURVEY
Sample size distribution

Total Doctors covered:102

ICU TYPES

1. On an average, how many patients do you care in the Intensive care unit in a month?

1a)On an average, how many NEW Patients do you care in the Intensive care unit in a month?

\

2. According to you what is the role of sedative agents in Intensive Care Unit?

3. Mention the sedative agents for sedation in ICU and please mention them?

3a) Mention the Anaesthetic agents for sedation in ICU and please mention them?

Hospital wise

City wise analysis

4. Please give the parameters that are considered to be important while using a Sedative drug for ICU sedation

Top of the mind

5. Out of total number of patients to how many patients or on what percentage you use sedative agents in ICU per month

6. Please specify the sedative drugs/ anesthetic agents used for ICU Sedation for the Intubated ICU patients?

Top of mind

6. Please specify the sedative drugs/ anesthetic agents used for ICU Sedation for the Non-Intubated ICU patients?

7. In your clinical practice, do you use analgesic drugs for sedation in ICU?

8. Can you please recall any sedative molecule/brand having an additional analgesic property

Top of mind

8. Could you please mention the average number of patients on whom you use dexmedetomidine for sedation in ICU per month

Hospital wise

7. Kindly mention advantages of Dexmedetomidine molecule when compared to other molecules used for sedation

Top of mind

10.Kindly specify the reasons for not using dexmedetomidine molecule

Top of mind

City wise analysis

Hospital wise analysis

RESEARCH FINDINGS

1. Majority ICUs : ICCU 36% MICU 29% NICU 16% 2. More average no. of patients/month: Govt. hospitals Corporate hospitals Research Institute 3. Role of dexmedetomidine in ICUs : mechanically ventilated patients 4. Parameters considered important for the patients: Vitals Respiratory Depression Haemodynamic stability 5. Anesthetic agent for sedation : Propofol, Sedative agent for sedation : Midazolam 6. Out of total No. of patients,Intensivists are using sedative agents maximum in Research Institute Corporate Hospital Govt. Hospital 7. Out of 1-4 No. of days, Maximum Intensivists are using sedative agents for less than 1 day (66%) followed by 2 ,3 & 4 days and maximum No. of days vary from 10-30 8. For non-intubated patients in ICU, agents used are: Midazolam Fentanyl Not used 9. For intubated patients : Midazolam Propofol Dexmedetomidine 10. 92 % Intensivists are also using analgesic drugs for sedation , most frequently used drugs are Fentanyl Pentazocine Pethidine 11. Sedative molecule having additional analgesic property: no response(26%) dexmedetomidine(25%) Fentanyl Morphine 12. 61 % intensivists said yes for use of dexmedetomidine 13. Dexmedetomidine is used maximum in Research institute Corporate Hospitals Government Hospitals 14. Advantages of Dexmedetomidine molecule compared to other molecules : Effective agent sedative + analgesic Less side effects easy arousibility Concious sedation
Top of the mind advantage: Sedative + Analgesic
Over Propofol: Easy wean off Haemodynamic stability Intrinsic property
Over Fentanyl: No respiratory depression More effective Easy to wean off
Over Midazolam: Short Acting Less Sedation Less cumulation Less respiratory depression
15. Reasons of not using Dexmedetomidine: Unaware Cost Empirical knowledge Availability

ANAESTHESIOLOGISTS SURVEY

The reason for conducting marketing research to anaesthesiologist is the molecule can be positioned to anaesthetists during surgeries as an sedative and analgesic drug.
I have targeted mainly major hospitals in all the cities covering nearly 81 anaesthesiologists in eight cities

Sample distribution among cities

TYPE OF HOSPITALS

1. On an average, how many surgeries do you attend in a month

2. Mention the anaesthetic agents used for different surgeries as per your priorities.

Overall anaesthetic molecules used for sedation

Anaesthetic agents used for sedation in different surgeries

3. Please mention the parameters that you considered most important while using a Sedative drug for surgeries

Top of mind

4. Could you please mention the purpose and benefits of sedative drugs during peri-operative conditions?

5. Do you change sedative agents according to the type of surgery

6. Can you please recall any sedative molecule/brand having an additional analgesic property

7. Do you use Dexmedetomidine in surgeries?

8. Please mention the surgeries, Dexmedetomidine is preferred by you.

Top of Mind

9. Kindly mention advantage of Dexmedetomidine molecule when compared to other molecules used for sedation

Top of mind

10. How Dexmedetomidine can be best used for surgeries

1. Important parameters that anaesthesiologists consider are : Vital parameters (22%) , Respiratory Depression (13%), Haemodynamic Stability(8%) ,Saturation of co2 (7%)
2. Majority of sedative agents are administered through Intravenous and oral route during pre, intra and post surgeries. Dexmedetomidine is administered through intravenous and intraspinal routeMost of the analgesic drugs are administered through Epidural, spinal and intravenous route. Muscle relaxants used through intramuscular route
3. The purpose of a sedative agent in Presurgery- Anxiolysis (56%),Sedation (10%), Amnesia (7%)
Intraoperative – hemodynamic stability (19%), CVS stability, faster recovery Post surgery – sedation (19%) and analgesia(11%)
4 . 39% of the anaesthesiologists recalled dexmedetomidine as molecule having both sedative and analgesic properties followed by fentanyl (16%), clonidine(13%) 5. Surgeries where dexmedetomidine is mostly used are Laproscopy(20%) , pediatric (18%) and knee replacement surgeries(16%) 6. 6. Anaesthesiologist view dexmedetomidine as adjuvant to anaesthetic agent(43%), sedative and analgesic drug (27%), sedative (15%) , analgesic (10%) 7. Reasons for not using dexmedetomidine in surgeries are cost (31%) and availability (24%) 8. Advantages of dexmedetomidine when compared to other molecules are : Easy arousability (20%) , Sedative and Analgesic(19%), Less side effects (18%)

Recommendations

Positioning in ICU rather than OT ICCU (Mechanically ventilated patients) 1. Target the Government Hospitals 2. Change of Perception Propofol dexmedetomidine (anaesthetics) Midazolam dexmedetomidine (sedatives) 4. Availability of Dexmedetomidine vials 5. Reason Unaware (CME) INTENSIVA DIVISION 6. Target as drug of choice for Laproscopy, Pediatric and Endoscopy 7. Anaesthesiologist Peri -operative procedures, PACU

Intensivists questionnaire
Good Morning/Good Afternoon Sir/Ma’am
I, ________ pursuing M.B.A from NIPER. As part of our curriculum we need to do a project in Anesthetic Segment. I would be grateful if you could spare few minutes to participate in it; your cooperation in this regard is highly appreciated. As per the ethics of Market research society of India, your identity will be kept confidential and we will only be sharing summarized results in our presentations. Name | | Qualification | | City / Address | | Years of Experience | | Attached Hospital | | Total Number of Beds in Hospital | | Number of Intensive Care Units | | Name of ICU | MICU / ICCU / NICU | Number of Beds in Intensive Care Unit | | 9. On an average, how many patients do you care in the Intensive care unit in a month?

Parameter | Number of Patients | Total ICU Patients / Month | | New patients/month | | 10. According to you what is the role of sedative agents in Intensive Care Unit? | | 11. Whether you use sedative agents or anesthetic agents for sedation in ICU and please mention them?

No | Anesthetic agent | Sedative agent | 1 | | | 2 | | | 3 | | | 4 | | | 5 | | |

12. Please give the parameters that are considered to be important while using a Sedative drug for ICU sedation

No | Parameters | 1 | | 2 | | 3 | | 4 | | 5 | | 13. -------------------------------------------------
Out of total number of patients to how many patients or on what percentage you use sedative agents in ICU per month ___________________________

14. Generally for what no. of days you use sedative agent in ICU?

<24 hrs | | >48 hrs | | 24-48 hrs | | Maximum days | |

9. Please specify the sedative drugs/ anesthetic agents used for ICU Sedation for the following ICU patients?

Type of patient | Molecules | Intubated patients | | Non-intubated | | 10. In your clinical practice, do you use analgesic drugs for sedation in ICU? Yes (Go to Next Question) | | No (Go to Question 11) | |

11. If yes, kindly tell the dugs you prefer

Drugs | Please specify | Fentanyl | | Sufentanyl | | Morphine | | Any other | |

12. Can you please recall any sedative molecule/brand having an additional analgesic property _____________________________

13. Do you use Dexmedetomidine for sedation in ICU patients?

Yes (Go to Next Question) | | No (Go to Question 14) | |

14. Could you please mention the average number of patients on whom you use dexmedetomidine for sedation in ICU per month
__________________

15. Kindly mention any one advantage of Dexmedetomidine molecule when compared to other molecules used for sedation

Compared with | Advantages | Midazolam(sedative agent) | | Propofol(anesthetic agent) | | Fentanyl(analgesic agent) | | 16. If no, then kindly specify the reasons for not using Dexmedetomidine molecule Reasons | Specify please | Unaware | | Efficacy of molecule | | Side effects | | Empirical knowledge | | Any other | | 17. Could you please mention the dosage pattern of various sedative/anesthetic drugs in ICU sedation Sedative Agents | Dosage | | Loading | Maintenances | | | | | | | | | | Your Opinion Is Valuable To us

Anaesthesiologist questionnaire

Good Morning/Good Afternoon Sir/Ma’am
I ________ pursuing M.B.A from NIPER. As part of our curriculum we need to do a project in Anesthetic Segment. I would be grateful if you could spare few minutes to participate in it; your cooperation in this regard is highly appreciated. Name | | Qualification | | City / Address | | Years of Experiences | | Attached Hospital | | Total Number of Beds in Hospital | |

1. On an average, how many surgeries do you attend in a month?

Total Surgeries / Month | |

2. Please mention the sedative agents and anesthetic agents used for different surgeries as per your priorities. | Type of Surgeries | Sedative agent | Anesthetic agent | 1 | | | | 2 | | | | 3 | | | |

3. Please mention the parameters that you considered most important while using a Sedative drug for surgeries

| Parameters | 1 | | 2 | | 3 | |

4. What are the different modes of administration through which the anesthetic and sedative agents are used during surgeries? Stages | Sedative Agent (Name it) | Anesthetic Agent (Name it) | Mode of administration | Pre Surgery | | | | Induction | | | | Maintenance | | | | Post surgery | | | |

5. Could you please mention the purpose and benefits of sedative drugs during peri-operative conditions?

Different stages | Purpose & Benefits | Pre operative | | Intra operative | | Post operative | |

6. Do you change sedative agents according to the type of surgery Yes (Go to Next Question) | | No (Go to Question 8) | |

7. Can you please recall any sedative molecule/brand having an additional analgesic property ________________________________________

8. Do you use Dexmedetomidine in surgeries?

Yes (Go to Next Question) | | No (Go to Question 15) | |

9. Could you please mention the average number of patients on whom you use dexmedetomidine for sedation during surgeries per month
__________________

10. Please mention the surgeries, Dexmedetomidine is preferred by you. 1. | | 2. | | 3. | | 4. | | 5. | |

11. Kindly mention any one advantage of Dexmedetomidine molecule when compared to other molecules used for sedation

Compared with | Advantage | Midazolam(sedative agent) | | Propofol(anesthetic agent) | | Fentanyl(analgesic agent) | |

12. How Dexmedetomidine can be best used for surgeries? (Please Tick)

Anesthetic agent | | Sedative & Analgesic | | Sedative agent | | Adjuvant to Anesthetic Agent | | Analgesic agent | | | | 13. If no, then kindly specify the reasons for not using Dexmedetomidine molecule (Branching from Q10) Reasons | Specify please | Unawareness of molecule | | Efficacy of molecule | | Side effects | | Empirical knowledge | | Any other (Please mention) | | 14. Does the post operative condition of the patient influence you for selection of anesthetic agent? Yes | | No (Go to Question 15) | | 15. Which of the following side effects you will not like to have in your anesthetic agent? Rank them. Parameters | Most important | Somewhat important | Important | Less important | Least important | Nausea & Vomiting | | | | | | Hallucination | | | | | | Delirium | | | | | | Respiratory depression | | | | | | Late Recovery | | | | | | 16. Could you please mention the dosage pattern of various sedative agents Sedative agents | Loading dose | Maintenance dose | | | | | | | | | | | | | | | |

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