IRCT | Evaluation and comparison of hemodynamic indices during head holding pinning in neurosurgery procedures in two groups receiving Dexmedetomidine and Midazolam (Isfahan, 1397)

Protocol summary

Study aim: The aim of this study was to determine and compare the hemodynamic parameters (systolic and diastolic blood pressure, mean blood pressure and heart rate) during the preservation of the head holder pinning in neurosurgery operations in the two groups receiving midazolam and doxedmodyntidine.
Design: This clinical trial is randomized, without any control group, with parallel and double-blind groups.
Settings and conduct: Participants of elective neurosurgical patients are selected after evaluating entry and exit criteria and are randomly assigned to receive midazolam or doxedetomidine. Hemodynamic indices are recorded at the time before, 1, 2, and 3 minutes after the preservation of the head holder pinning.
Participants/Inclusion and exclusion criteria: Age between 20 and 70 years, insensitivity to anesthetic drugs, no antihypertensive drug
Intervention groups: First, all patients are anesthetized with fentanyl and atracurium and propofol. To maintain anesthesia, members of the first group (doxedetomidine) use doxedetomidine at a dose of 1 microgram per kg of body weight per hour, and for the anesthetic maintenance, members of the second group (midazolam) receive 0.6 mg / kg of midazolam The body weight is used per hour. Hemodynamic indices are recorded in a period of time.
Main outcome variables: Systolic and diastolic blood pressure, mean blood pressure and heart rate

General information

Reason for update
Acronym
IRCT registration information: IRCT registration number: IRCT20110528006617N3

Registration date: 2019-05-06, 1398/02/16

Registration timing: retrospective

Last update: 2019-05-06, 1398/02/16

Update count: 0
Registration date: 2019-05-06, 1398/02/16

Registrant information: Name

Mehrdad Masoudifar

Name of organization / entity

Esfahan University of medical sciences

Country

Iran (Islamic Republic of)

Phone

+98 31 1268 2007

Email address

masoudifar@med.mui.ac.ir

Recruitment status: Recruitment complete
Funding source

Expected recruitment start date: 2018-08-23, 1397/06/01
Expected recruitment end date: 2019-03-20, 1397/12/29
Actual recruitment start date: 2018-08-23, 1397/06/01
Actual recruitment end date: 2019-03-20, 1397/12/29
Trial completion date: 2019-03-20, 1397/12/29

Scientific title: Evaluation and comparison of hemodynamic indices during head holding pinning in neurosurgery procedures in two groups receiving Dexmedetomidine and Midazolam (Isfahan, 1397)

Public title: The Effect of Dexmedetomidine and Midazolam on Hemodynamic Indices During Anesthesia
Purpose: Treatment
Inclusion/Exclusion criteria: Inclusion criteria:

Age between 20 and 70 years Patients who consent to the informed consent to participate in the study.

Exclusion criteria:

Patients who are not allergic to anesthetic drugs. Patients who do not take anti hypertensive drugs to control their blood pressure. Patients who do not receive the Nimodipin drug due to hemorrhage of the subaracnoide.
Age: From 20 years old to 70 years old
Gender: Both

Phase

2-3

Groups that have been masked

Participant
Care provider
Investigator
Outcome assessor

Sample size

Target sample size: 70

Actual sample size reached: 63

Randomization (investigator's opinion)

Randomized

Randomization description

Individuals selected in this trial are sequentially divided into two groups of D and M by randomized block method. Group M received Midazolam and the D group received Dexmedetomidine during anesthesia.

Blinding (investigator's opinion)

Double blinded

Blinding description

Patient information is hidden by the operating room nurse and injectable drugs are also provided to the physician in similar syringes by an anesthetic technician, while the physician will not have any knowledge concerning the substance in the syringe. In addition, the participants will not be informed about the injectable drugs in each syringe and the names of the operating room personnel.

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

Isfahan University of Medical Sciences, Hezar Jarib Ave

City

Isfahan

Province

Isfehan

Postal code

7346181746
Approval date: 2017-12-20, 1396/09/29
Ethics committee reference number: IR.MUI.REC.1396.3.979

Health conditions studied

1

Description of health condition studied: General Anesthesia
ICD-10 code: T88.5
ICD-10 code description: Other complications of anesthesia

Primary outcomes

1

Description: Systolic blood pressure
Timepoint: Before intervention and 1 , 2 , 3 min after intervention
Method of measurement: mm-hg, sphygmomanometer

2

Description: Diastolic bllod pressure
Timepoint: Before intervention and 1 , 2 , 3 min after intervention
Method of measurement: mm-hg, sphygmomanometer

3

Description: Mean arterial pressure
Timepoint: Before intervention and 1 , 2 , 3 min after intervention
Method of measurement: mm-hg, sphygmomanometer

4

Description: Heart rate
Timepoint: Before intervention and 1 , 2 , 3 min after intervention
Method of measurement: ECG monitor

Secondary outcomes

1

Description: Hypotension
Timepoint: Before intervention and 1 , 2 , 3 min after intervention
Method of measurement: mm-Hg, sphygmomanometer

2

Description: Hypertension
Timepoint: Before intervention and 1 , 2 , 3 min after intervention
Method of measurement: mm-Hg, sphygmomanometer

3

Description: Tachycardia
Timepoint: Before intervention and 1 , 2 , 3 min after intervention
Method of measurement: ECG monitor

4

Description: Bradycardia
Timepoint: Before intervention and 1 , 2 , 3 min after intervention
Method of measurement: ECG monitor

Intervention groups

1

Description: The first intervention group(Dexmedetomidine): Initially, for primary anesthetic, patients receive 2 mg / kg of propofol and 0.5 microgram per kilogram of atherocorum and fentanyl is injected at 3 micrograms per kg of body weight.To maintain anesthesia, they are given a dose of 1mg per kg body weight / hour of doses of dexmedetomidine.
Category: Treatment - Drugs

2

Description: The second intervention group (midazolam): Initially, for primary anesthetic, patients receive 2 mg / kg of propofol and 0.5 microgram per kilogram of atherocorum and fentanyl is injected at 3 micrograms per kg of body weight. To maintain anesthesia, they use Midazolam infusion at a dose of 0.6 mg / kg body weight per hour.
Category: Treatment - Drugs

Recruitment centers

1

Recruitment center: Name of recruitment center

Saint Zahra hospital

Full name of responsible person

Mehrdad Masoudifar

Street address

Saint Zahra hospital, Sofe Blvd., Shahid Keshvari highway

City

Isfahan

Province

Isfehan

Postal code

8174675731

Phone

+98 31 3620 2020

Email

alzahra@mui.ac.ir

Web page address

1

Sponsor: Name of organization / entity

Esfahan University of Medical Sciences

Full name of responsible person

Shaghayegh Haghjoo Javanmard

Street address

Isfahan University of Medical Sciences , Hezar Jarib Ave.

City

Isfahan

Province

Isfehan

Postal code

7346181746

Phone

+98 31 3668 8138

Fax

Email

sh_haghjoo@med.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

Mehrdad Masoudifar

Position

Associate Professor

Latest degree

Specialist

Other areas of specialty/work

Anesthesiology

Street address

Isfahan University of Medical Sciences , Hezar Jarib Ave.

City

Isfahan

Province

Isfehan

Postal code

7346181746

Phone

+98 913 316 2343

Email

masoudifar@med.mui.ac.ir

Person responsible for scientific inquiries

Contact: Name of organization / entity

Esfahan University of Medical Sciences

Full name of responsible person

Mehrdad Masoudifar

Position

Associate professor

Latest degree

Specialist

Other areas of specialty/work

Anesthesiology

Street address

Isfahan University of Medical Sciences , Hezar Jarib Ave.

City

Isfahan

Province

Isfehan

Postal code

7346181746

Phone

+98 913 316 2343

Email

masoudifar@mui.ac.ir

Person responsible for updating data

Contact: Name of organization / entity

Esfahan University of Medical Sciences

Full name of responsible person

Mehrdad Masoudifar

Position

Associate professor

Latest degree

Specialist

Other areas of specialty/work

Anesthesiology

Street address

Isfahan University of Medical Sciences , Hezar Jarib Ave.

City

Isfahan

Province

Isfehan

Postal code

7346181746

Phone

+98 913 316 2343

Email

masoudifar@mui.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: 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

Evaluation and comparison of hemodynamic indices during head holding pinning in neurosurgery procedures in two groups receiving Dexmedetomidine and Midazolam (Isfahan, 1397)