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Comparison of the effects of midazolam and dexmedetomidine on sedation levels, hemodynamics and complications in patients under brain stereotaxic surgery

Protocol summary

Study aim
Comparison of the effects of midazolam and dexmedetomidine on sedation levels, hemodynamics and complications in patients under brain stereotaxic surgery
Design
This study is a clinical trial with a control group ,parallel group, double blind, randomized, and sample size of 64 patients.
Settings and conduct
This study was a double-blind clinical trial that was performed on 64 patients undergoing stereotaxic surgery that referred to university hospitals of Isfahan University of Medical Sciences (Al-Zahra and Kashani). Patients in this study were randomly divided into two groups of 32 patients, one of them was sedated with midazolam, and the other group was sedated with dexmedetomidine. The blindness of this study was that patients and anesthetic technicians did not know any type of drug that was injected. Patients in the first group received midazolam at a dose of 1 mg/kg, and the second group received intravenous dose of 1 mcg /kg/min of dexmedetomidine.
Participants/Inclusion and exclusion criteria
inclusion criteria: 1)patients candidates brain stereotaxic surgery 2)age between 18 and 60 3)No history of allergic reaction to both midazolam and dexmedetomidin exclusion criteria: 1)any change in anesthesia or surgery plan due to any complication 2)patient expiration during surgery
Intervention groups
Patients in this study were randomly divided into two groups of 32 patients, one of them was sedated with midazolam, and the other group was sedated with dexmedetomidine.
Main outcome variables
Hemodynamic parameters including systolic and diastolic blood pressure, heart rate and respiratory rate at preoperative time, 1, 3, 5, 10 and 20 minutes during surgery, degree of sedation, patient and surgeon satisfaction, recovery time and complications of surgery including bleeding, low blood oxygen saturation and respiratory apnea was measured.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160307026950N12
Registration date: 2019-06-06, 1398/03/16
Registration timing: retrospective

Last update: 2019-06-06, 1398/03/16
Update count: 0
Registration date
2019-06-06, 1398/03/16
Registrant information
Name
Behzad Nazemroaya
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3212 3543
Email address
behzad_nazem@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2019-03-20, 1397/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of midazolam and dexmedetomidine on sedation levels, hemodynamics and complications in patients under brain stereotaxic surgery
Public title
The effects of midazolam and dexmedetomidine in patients under stereotaxic surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients candidates brain stereotaxic surgery age between 18 and 60 No history of allergic reaction to both midazolam and dexmedetomidin
Exclusion criteria:
any change in anesthesia or surgery plan due to any complication patient expiration during surgery
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
Sample size
Target sample size: 64
Randomization (investigator's opinion)
Randomized
Randomization description
patients randomly assigned to two different groups A and B with Random Allocation computer software
Blinding (investigator's opinion)
Double blinded
Blinding description
patients and anesthetic technician did not know about administering drugs
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Hezarjarib street
City
isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2019-03-16, 1397/12/25
Ethics committee reference number
IR.MUI.MED.REC.1397.350

Health conditions studied

1

Description of health condition studied
respiratory apnea
ICD-10 code
R06.81
ICD-10 code description
Apnea, not elsewhere classified

2

Description of health condition studied
systolic and diastolic blood pressure
ICD-10 code
I95.2
ICD-10 code description
Hypotension due to drugs

3

Description of health condition studied
heart rate
ICD-10 code
R00.1
ICD-10 code description
Bradycardia, unspecified

4

Description of health condition studied
drug sedation level
ICD-10 code
Y47
ICD-10 code description
Sedatives, hypnotics and antianxiety drugs

5

Description of health condition studied
bleeding
ICD-10 code
T81.0
ICD-10 code description
Haemorrhage and haematoma complicating a procedure, not elsewhere classified

6

Description of health condition studied
oxygen saturation level
ICD-10 code
R09.0
ICD-10 code description
Asphyxia and hypoxemia

Primary outcomes

1

Description
systolic and diastolic blood pressure
Timepoint
preoperative periods, 1, 3, 5, 10 and 20 minutes during surgery
Method of measurement
Non-invasive barometer

2

Description
heart rate
Timepoint
preoperative periods, 1, 3, 5, 10 and 20 minutes during surgery
Method of measurement
pulse oximetry device

3

Description
respiratory rate
Timepoint
preoperative periods, 1, 3, 5, 10 and 20 minutes during surgery
Method of measurement
Count in minute

4

Description
drug sedation level
Timepoint
after end of surgery
Method of measurement
Ramsay sedation scale

5

Description
patient satisfaction
Timepoint
after end of surgery
Method of measurement
Visual Analogue Scale

6

Description
surgeon satisfaction
Timepoint
after end of surgery
Method of measurement
Iowa Satisfaction with Anesthesia Scale

7

Description
recovery time
Timepoint
From the moment of finishing surgery to full recovery time
Method of measurement
In minute using a chronometer

8

Description
bleeding
Timepoint
after end of surgery
Method of measurement
Bleeding above 50 cc

9

Description
low blood oxygen saturation
Timepoint
during surgery
Method of measurement
The drop in oxygen saturation below 90% by pulse oximeter

10

Description
respiratory apnea
Timepoint
during surgery
Method of measurement
Respiratory arrest for more than 8 seconds measured by chronometer

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group A: Initially, personal consent is obtained from the patients. Then the patient is placed on the operating bed and standard monitoring devices including pulsoximetry, capnography, and electrocardiogram are attached. Patients in this group received midazolam at a dose of 1 mg/kg IV bolus.
Category
Treatment - Drugs

2

Description
Intervention group B: Initially, personal consent is obtained from the patients. Then the patient is placed on the operating bed and standard monitoring devices including pulsoximetry, capnography, and electrocardiogram are attached. The second group received intravenous dose of 1 mcg/kg/min of dexmedetomidine.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Alzahara hospital
Full name of responsible person
Behzad Nazemroaya
Street address
Soffeh boulivard, Shahid Kesari highway
City
isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
behzad_nazem@med.mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
shaghayegh haghjoo
Street address
Hezar Jarib Street
City
isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
mehdi khademi
Position
medical student / intern
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
shariati street
City
khorram abad
Province
Lorestan
Postal code
6818795459
Phone
+98 66 3330 9832
Email
mehdi.kh199271@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Behzad Nazemroaya
Position
Assistant Professor/Faculty
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Department of Anesthesiology, AL-Zahra Hospital
City
Isfahan
Province
Isfehan
Postal code
8146713543
Phone
+98 31 3620 2020
Fax
Email
behzad_nazem@med.mui.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
mehdi khademi
Position
medical student / intern
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
shariati street
City
khorram abad
Province
Lorestan
Postal code
6818795459
Phone
+98 66 3330 9832
Email
mehdi.kh199271@gmail.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
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