comparison of the effect of Dexmedetomidine and Ketamine on the depth of anaesthesia in patients under neuromonitoring
Design
A parallel-group, double-blind, randomized clinical trial on 70 patients.
Settings and conduct
A double-blind study will be conducted in Ahvaz Golestan Hospital to compare the effect of dexmedetomidine and ketamine in the depth of anesthesia in patients under neuromonitoring. Patients are divided into two groups (35 people in each group). The results will be checked before anesthesia and every 15 minutes after anesthesia until the end of surgery.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age 20 to 60 years, patients with ASA CLASS 1 & 2, patients who consent to participate in the study. Exclusion criteria: patients with severe heart disease, patients with severe pulmonary and respiratory problems, patients with kidney failure, fever, infection, electrolyte disorder, acid and base disorder, and allergy to the study drugs.
Intervention groups
The first group includes 35 patients who will be infused with 0.2 micrograms/kg/minute of dexmedetomidine + 0.1 micrograms/kg/minute of Remifentanil + 0.5mg/kg/hour of propofol. The second group includes 35 patients who will undergo an infusion of 0.5 mg/kg/hour of ketamine + 0.1 μg/kg/minute of Remifentanil + 0.5 mg/kg/hour of propofol.
Main outcome variables
Relaxation level, level of consciousness, Vital signs.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240507061698N1
Registration date:2024-05-14, 1403/02/25
Registration timing:prospective
Last update:2024-05-14, 1403/02/25
Update count:0
Registration date
2024-05-14, 1403/02/25
Registrant information
Name
Seyedeh mohadaseh Azizanmortazavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3373 8537
Email address
mortazavi.mo@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-30, 1403/03/10
Expected recruitment end date
2024-08-31, 1403/06/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison of the effect of Dexmedetomidine and Ketamine on the depth of anesthesia in patients under neuromonitoring
Public title
Effect of dexmedetomidine and ketamine in deep anesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 20 to 60 years
Patients with ASA CLASS 1 & 2
Patients who consent to participate in the study
Exclusion criteria:
Patients with severe heart disease
Patients with severe pulmonary and respiratory problems
Patients with kidney failure, fever, infection, electrolyte disorder, acid-base disorder, allergy to the studied drugs
Age
From 20 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Patients with eligible criteria will be divided into two intervention groups completely randomly using the method of random block permutations. An online website (https://www.sealedenvelope.com) is used to generate a random list based on the desired sample size and block size of 4. After creating a list, each patient will be identified with a unique code throughout the study. 35 people are selected for the first intervention group and 35 people for the second intervention group.
Blinding (investigator's opinion)
Double blinded
Blinding description
The participant, the researcher, and the treatment staff are kept blind, and the drugs are adjusted by an Anesthesiologist not related to the research.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Ahvaz Jundishapur University of Medical Sciences, Esfand St., Golestan St.
City
Ahvaz
Province
Khouzestan
Postal code
6441945781
Approval date
2024-04-20, 1403/02/01
Ethics committee reference number
IR.AJUMS.REC.1403.017
Health conditions studied
1
Description of health condition studied
Abnormalities of the spine
ICD-10 code
G95.9
ICD-10 code description
Disease of spinal cord, unspecified
Primary outcomes
1
Description
Relaxation level
Timepoint
Before anesthesia, every 15 minutes until the end of surgery
Method of measurement
RAMSEY criterion
2
Description
level of consciousness
Timepoint
Before anesthesia, every 15 minutes until the end of surgery
Method of measurement
bispectral index (BIS) criterion
3
Description
Vital signs
Timepoint
Before anesthesia, every 15 minutes until the end of surgery
Method of measurement
Vital signs monitor
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The first group includes 35 patients who will be infused with 0.2 micrograms/kg/minute of dexmedetomidine + 0.1 micrograms/kg/minute of Remifentanil + 0.5mg/kg/hour of propofol.
Category
Treatment - Drugs
2
Description
Intervention group: The second group includes 35 patients who will undergo infusion of 0.5 mg/kg/hour of ketamine + 0.1 μg/kg/minute of Remifentanil + 0.5 mg/kg/hour of propofol.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahvaz Golestan Hospital
Full name of responsible person
Seyedeh mohadaseh Azizanmortazavi
Street address
Ahvaz Jundishapur University of Medical Sciences, Esfand St., Golestan St.
City
Ahvaz
Province
Khouzestan
Postal code
6441945781
Phone
+98 61 3373 8537
Email
mortazavi.mo@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mehrnoosh Zakerkish
Street address
Golestan St., Golestan Blvd., Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3314 0000
Email
itc@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz University of Medical Sciences
Proportion provided by this source
100
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
Ahvaz University of Medical Sciences
Full name of responsible person
Seyedeh mohadaseh Azizanmortazavi
Position
General Practitioner
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Golestan St., Golestan Blvd., Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 916 505 1148
Fax
Email
mortazavi.mo@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Seyedeh mohadaseh Azizanmortazavi
Position
General Practitioner
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Golestan St., Golestan Blvd., Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 916 505 1148
Fax
Email
mortazavi.mo@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Seyedeh mohadaseh Azizanmortazavi
Position
General Practitioner
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Golestan St., Golestan Blvd., Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 916 505 1148
Fax
Email
mortazavi.mo@ajums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available