Aim: To explore the possible association of CYP2A6 and ADRA2A genetic variants altering in dexmedetomidine response in Pakistani patients.
Objectives:
1. To determine the frequency of genes polymorphism in CYP2A6 and ADRA2A in Pakistani patients.
2. To correlate ADRA2A gene polymorphisms with clinical effects of dexmedetomidine
3. To determine the association of CYP2A6 polymorphism to serum concentration of dexmedetomidine.
Design
Interventional, single blinded parallel longitudinal study
Settings and conduct
The study will be conducted at Pakistan Ordinance Factories (POFs) Hospital and Wah Medical College(WMC), Wah Cantt, in collaboration with Islamic International Medical College (IIMC) Rawalpindi Pakistan,
Participants/Inclusion and exclusion criteria
Inclusion criteria: Pakistani individuals between of age 06-60 years undergoing elective surgeries selected according to American Society of Anesthesiology classification I–II (Healthy person, Mild systemic disease)
Exclusion criteria: Patients with
• Hypertension & Diabetes
• Pulmonary diseases
• Arrhythmias
• Compromised renal and hepatic functions
• Cognitive impairment, neurological disease
• Pre-operative morphine consumption, or on antidepressant, on drug abuse
• Non- Pakistani origin
• Patients not giving consent
• Females not pregnant
Intervention groups
Intervention Group will be administered 1µg/kg dexmedetomidine hydrochloride intravenously over 10 min as a bolus just before the induction in addition to the standard anaesthesia protocol, followed by maintenance dose of 0.5 μg/kg/hr. till the end of surgery.
Main outcome variables
Seadtion, Analgesia, Genotyping and Polymorphism in Receptor and enzyme determining the pharmakodynamic and pharmakokinetic of dexmeditomidine
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230824059251N1
Registration date:2023-09-01, 1402/06/10
Registration timing:prospective
Last update:2023-09-01, 1402/06/10
Update count:0
Registration date
2023-09-01, 1402/06/10
Registrant information
Name
Khalida Ajmal
Name of organization / entity
Wah Medical College--A project of POF Trust
Country
Pakistan
Phone
+92 51 9094000
Email address
mrskhalida57@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-10, 1402/06/19
Expected recruitment end date
2023-12-30, 1402/10/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Impact of ADRA2A and CYP2A6 Gene Polymorphism on sedative and analgesic effect of Dexmedetomidine
Public title
Dexmeditomidine as adjuvant to anesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
ASA I &II
Pakistani origin
Exclusion criteria:
No co-morbidity
Non pregnant females
Age
No age limit
Gender
Both
Phase
4
Groups that have been masked
Participant
Sample size
Target sample size:
300
More than 1 sample in each individual
Number of samples in each individual:
3
blood samples taken at 0, 1/2 hrs and 2 hrs time interval
Randomization (investigator's opinion)
Randomized
Randomization description
The patients fullfiling the inclusion criteia, will be randomized into two groups by computer generated random numbers( Simple ramdomization) by assibning participants in control group with odd numbers and intervention group with even number. intervention Group will be administered 1µg/kg dexmedetomidine hydrochloride diluted in 20ml normal saline intravenously over 10 min as a bolus just before the induction in addition to the standard anaesthesia protocol, followed by maintenance dose of 0.5 μg/kg/hr in another 20 ml of saline till the end of surgery.The control group will receive 20ml intravenous infusion of normal saline 0.9 % over 10 minutes followed by continuous infusion of 12.5 ml of normal saline till the end of surgeryin addition to anesthetic agents decided. Pre-operative variable like demographic data ,hemodynamics profile,then at three point interval blood sampling for drug levels, anti-inflammatory markers and genotyping and levels of analgesia and sedation will be assessed as described in next section.
Blinding (investigator's opinion)
Single blinded
Blinding description
All participants were not given information about the investgational drug. Half of the participants were inculded in cntrol group and the other half as interventional study group.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Intsitutional Review Committee (IRC) Islamic International Medical College
Street address
276, Peshawer Road
City
Rawalpindi
Postal code
46000
Approval date
2023-01-06, 1401/10/16
Ethics committee reference number
Ripah/iRC/23/101
Health conditions studied
1
Description of health condition studied
Intraoperative sedation and analgesia
ICD-10 code
U00-U85
ICD-10 code description
Thr drug under study will be given as adjuvant to anesthesia to produce sedation and analgesia and reduce the dose of anesthetic agents, analgesic and drugs for neasea & vomiting.
Primary outcomes
1
Description
Intraoperative sedation and analgesia
Timepoint
beore interventiona and at 1/2 an hour interval and at 2hrs interval
Method of measurement
Ramsay Sedation scale, Visual analogue scale and polymorphism in genes
2
Description
Genotyping and Polymorphism in Receptor gene and in enzyme gene
Timepoint
Polymorphism cam be studies both in control and study group in blood sample of 2hsr interval
Method of measurement
Drug concentration will be meausred at 30 min and at 2hrs interval in both groups
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: intervention Group will be administered 1µg/kg dexmedetomidine hydrochloride intravenously over 10 min as a bolus just before the induction in addition to the standard anaesthesia protocol, followed by maintenance dose of 0.5 μg/kg/hr. till the end of surgery.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Pakistan Ordinance Factories Hospital , patients attending ENT department for Elective sugery
Full name of responsible person
Dr Rashada Farooqui
Street address
Quid Avenue , Wah Cantt
City
Wah Cantt
Postal code
47040
Phone
+92 314 5164991
Fax
+92 51 9314373
Email
dr.rashadafarooqi@gmail.com
Web page address
https://wahmedicalcollege.edu.pk/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic International Medical College and Wah medical college
Full name of responsible person
Intsitutional Review Committee (IRC) Islamic International Medical College
Street address
276 Peshawer Road and Quid Avenue , Wah Cantt
City
Rawalpindi and Wah Cantt
Postal code
46000, 47040
Phone
+92 51 9094111
Fax
+92 51 9314373
Email
info@wahmedicalcollege.edu.pk
Web page address
https://wahmedicalcollege.edu.pk/
Grant name
No funding is provide excet the permission to use the facility.All requirments for administration of drug and collecting, storing and cetrifuging the blood samples till it reach for biochemical analysis
Grant code / Reference number
no
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
no
Proportion provided by this source
1
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic International Medical College and Wah medical college
Full name of responsible person
Brig (R) Dr Akbar Waheed
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
Pharmacology and toxicology
Street address
276 Peshawer Road
City
Rawalpindi
Province
Punjab
Postal code
46000
Phone
+92 51 9094111
Email
akbar.waheed@riphah.edu.pk
Web page address
http://www.riphah.edu.pk
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic International Medical College
Full name of responsible person
Prof Dr Akbar Waheed Brig(R)
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Pharmacology and Toxicology
Street address
276 Peshawer Road
City
Rawalpindi
Province
Punjab
Postal code
46000
Phone
+92 51 111 510 510
Fax
+92 51 5567527
Email
akbar.waheed@riphah.edu.pk
Web page address
http://www.riphah.edu.pk
Person responsible for updating data
Contact
Name of organization / entity
Wah Medical College--A project of POF Trust
Full name of responsible person
Dr Khalida Ajmal
Position
Professor
Latest degree
Master
Other areas of specialty/work
Pharmacology and Toxicology
Street address
Quid Avenue , Wah Cantt
City
Wah Cantt
Province
PUNJAB
Postal code
47040
Phone
+92 51 9094111
Fax
+92 51 9314373
Email
info@wahmedicalcollege.edu.pk
Web page address
http://www.wahmedicalcollege.edu.pk
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD