A Comparison of Dexmedetomidine and Magnesium Sulfate as an Anesthetic Adjuant in trans-Sphenoid pituitary surgery
Design
In this randomized clinical trial study, 60 patients will be randomly divided into two groups, D and S, using quadruple blocks. After anesthesia of the patients, each patient will receive his intervention protocol and the two groups will be compared in terms of hemodynamic status and pain intensity after injecting the relevant drugs.
Settings and conduct
Patients participating in this study will be evaluated and intervened in the operating room of Loghman Hospital, and after being divided into intervention groups, will receive the relevant drug after anesthesia. During anesthesia, patients' hemodynamic status and pain intensity will be compared.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Candidate for pituitary surgery by transsphenoid method, general anesthesia and consent to participate in the study and Exclusion criteria: Sensitivity to the studied drugs and taking drugs that increase intracranial pressure.
Intervention groups
The participants will be divided into intervention 1 and intervention 2 groups. In intervention group 1, they will receive dexmedetomidine in the form of one microgram/kg bolus within ten minutes, and they will receive this medicine in the form of half a microgram/kg per hour until the end of the surgery. In intervention group 2: they will receive magnesium sulfate medicine in the form of 50 mg/kg bolus within ten minutes and they will receive this medicine in the form of 15 micrograms/kg per hour until the end of the surgery. Hemodynamic status will be recorded during surgery and pain intensity will be monitored for 12 hours after surgery.
Main outcome variables
Pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220528055003N1
Registration date:2022-07-13, 1401/04/22
Registration timing:prospective
Last update:2022-07-13, 1401/04/22
Update count:0
Registration date
2022-07-13, 1401/04/22
Registrant information
Name
Nina Pilevar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5102 5000
Email address
ninapilevar@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-21, 1401/04/30
Expected recruitment end date
2022-09-21, 1401/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Comparison of Dexmedetomidine and Magnesium Sulfate as an Anesthetic Adjuant in trans-Sphenoid pituitary surgery
Public title
Effects of dexmedetomidine and magnesium sulfate in the administration of pituitary surgery anesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Candidate for pituitary surgery by trans-sphenoid method
Candidate for general anesthesia
Satisfaction to participate in the study
Exclusion criteria:
Sensitivity to the studied drugs
Taking drugs that increase intracranial pressure
Age
From 18 years old to 75 years old
Gender
Both
Phase
2-3
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
This is a simple randomized clinical trial in which people are randomly assigned to study groups; In such a way that the required number of drugs are placed in opaque sealed envelopes that are coded. Each of the codes is also written on a paper, folded and placed inside a box, after entering the operating room, each patient takes out one of the papers from the box, the envelope has the same number as the number inside the selected paper, intervention It is applied to the patient. This work continues until the end of the papers, so that the number of patients reaches the desired volume in the groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
The outcome researcher will be unaware of the grouping of participants and the type of drug injected into patients; Therefore, the rejection of the study flow will remain blind.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
Loghman hakim Hospital. Makhsoos Ane, Southern Karehar Ave
City
Tehran
Province
Tehran
Postal code
3556896623
Approval date
2020-06-28, 1399/04/08
Ethics committee reference number
IR.SBMU.RETECH.REC.1399.274
Health conditions studied
1
Description of health condition studied
Pain
ICD-10 code
G89.11
ICD-10 code description
Acute pain due to trauma
Primary outcomes
1
Description
Pain
Timepoint
Up to 12 hours after the intervention and once every hour
Method of measurement
Visual Analog Scale
Secondary outcomes
1
Description
Hemodynamic status
Timepoint
From the beginning of the intervention to the end of the intervention (every three minutes)
Method of measurement
Monitoring hemodynamic status with the help of cardiopulmonary monitoring
Intervention groups
1
Description
Intervention group: Thirty patients who are candidates for pituitary surgery transferred to the operating room of Loghman Hakim Hospital (Tehran) will be included in this group randomly. After injection of anesthesia drugs and intratracheal intubation, they will receive dexmedetomidine in the form of one microgram / kg in ten minutes as a bolus, and until the end of the surgery, they will receive this drug in the form of half a microgram / kg per hour. Hemodynamic status will be recorded during surgery and pain intensity will be monitored for up to 12 hours after surgery.
Category
Treatment - Drugs
2
Description
Intervention group: Thirty patients who are candidates for pituitary surgery transferred to the operating room of Loghman Hakim Hospital (Tehran) will be included in this group randomly. After injecting anesthesia and intubation intubation, they will receive 50 mg / kg magnesium sulfate as a bolus within ten minutes and will receive 15 μg / kg per hour until surgery. Hemodynamic status will be recorded during surgery and pain intensity will be monitored for up to 12 hours after surgery.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Loghman Hakim Hospital
Full name of responsible person
Nina Pileh Var
Street address
Loghman Hakim Hospital, Special Street, South Kargar Street,
City
Tehran
Province
Tehran
Postal code
3696585859
Phone
+98 914 411 3557
Email
Ninapilevar@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Masoud Nashibi
Street address
Loghman Hakim Hospital, Special Street, South Kargar Street
City
Tehran
Province
Tehran
Postal code
3696585859
Phone
+98 914 411 3557
Email
Masoudnashibi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nina Pilevar
Position
Fellowship assistant
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Loghman Hakim Hospital, Special Street, South Kargar Street
City
Tehran
Province
Tehran
Postal code
3696585859
Phone
+98 21 5102 5000
Fax
Email
Ninapilevar@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nina Pilevar
Position
Fellowship assistant
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Loghman Hakim Hospital, Special Street, South Kargar Street
City
Tehran
Province
Tehran
Postal code
3696585859
Phone
+98 21 5102 5000
Fax
Email
Ninapilevar@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nina Pilevar
Position
Fellowship assistant
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Loghman Hakim Hospital, Special Street, South Kargar Street
City
Tehran
Province
Tehran
Postal code
3696585859
Phone
+98 21 5102 5000
Fax
Email
Ninapilevar@yahoo.com
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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available