Comparison effect of Midazolam and Dexmedtomidin , on hemodynamic changes during surgery and post operative complication in the surgery of Permcath implantation
Comparison effect of Midazolam and Dexmedmotidine on hemodynamic changes in patients undergoing Premcath implantation
Design
In this double blind randomized clinical trial study ,70 patents candidate for permcath implantation will be selected and randomly divided in to two group of 35 by Random allocation software. In the first group, 0.2 mg / kg / h of Midazolam and in the second group, 0.1 mg / kg / h, Doxedetomidine is injected immediately after induction of anesthesia. Hemodynamic characteristics and postoperative complications, including nausea and vomiting, and severity of pain in patients will be recorded.
Settings and conduct
This double blind clinical trial study will be conducted at Al-Zahra hospital in 2019 in Isfahan.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age range 18-65 years; (American Society of Anesthesiologists)ASA = 2 and 3; willingness to participate in the study
Non Inclusion criteria: receiving drugs that affect hemodynamic status; receiving anticoagulant drugs
Intervention groups
Intervention group 1: Injection of 0.2 mg / kg /hour of Midazolam
Intervention group 2: Injection of 0.1 ug / kg Doxedetomidine during 10 minutes immediately after induction of anesthesia.
Comparison effect of Midazolam and Dexmedtomidin , on hemodynamic changes during surgery and post operative complication in the surgery of Permcath implantation
Public title
Comparison of the effect of two drugs Midazolam and Dexmedetumidine on vital signs and postoperative complications
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age range of 65-18 years old
American Society of Anesthesiologists (ASA) score of II and III
Patient agrees to participate in the study
Exclusion criteria:
Receiving drugs that affect hemodynamic status
Receiving َAnticoagulant drugs
Age
From 18 years old to 65 years old
Gender
Both
Phase
1
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, 70 patients with inclusion criteria will be selected and randomly allocated to two groups of 35 by Randomization software.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients and researcher will be unaware of the allocation of patients to the groups. The drugs were prepared by one of the operating room personnel not included in the study in the same and encoded syringes and provided to the researcher for injection.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Medical Ethics Committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezarjerib street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2018-09-20, 1397/06/29
Ethics committee reference number
IR.MUI.REC.1396.3.784
Health conditions studied
1
Description of health condition studied
postoperative complicaqtions
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Blood Pressure
Timepoint
In every 10 minutes during surgery and recovery
Method of measurement
Pulse oximetry, Observation
2
Description
Heart Rate
Timepoint
In every 10 minutes during surgery and recovery
Method of measurement
Pulse oximetry
3
Description
Blood Oxygen Saturation
Timepoint
In every 10 minutes during surgery and recovery
Method of measurement
Pulse oximetry
4
Description
nausea
Timepoint
During stay of patients in recovery
Method of measurement
Observation
5
Description
Vomitting
Timepoint
During stay of patients in recovery
Method of measurement
Observation
Secondary outcomes
1
Description
Hemodynamic disorder
Timepoint
Every 10 minutes during surgery and recovery
Method of measurement
pulse oximetry
Intervention groups
1
Description
Intervention group: group of receive 0.1 micgr/kg intravenously Dexmedetomidine made by Exire company, during 10 minutes immediately after induction
Category
Treatment - Other
2
Description
Intervention group: group of receive 0.2 mg/kg intravenously Midazolam made by Exire company, during 10 minutes immediately after induction
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Sareh Sadat Shahidi
Street address
Soffeh Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3356 3466
Email
Shsare40@gmail.com
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
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3070
Email
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
Seyed Taghi Hashemi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Soffeh Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3669 2174
Email
st_hashemi@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Seyed Taghi Hashemi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Soffeh Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3669 2174
Email
st_hashemi@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ali Mehrabi Koushki
Position
ُSatistical Consultant
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
Hezar Jerib Street
City
Isfahan
Province
Isfehan
Postal code
8434193474
Phone
+98 31 3356 3466
Email
al.mehrabi@gmail.com
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