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Comparing the changes in hemodynamic and respiratory parameters in two methods of spinal anesthesia versus general anesthesia in diagnostic gynecologic laparoscopy

Protocol summary

Study aim
Reduction of hemodynamic and respiratory complications in diagnostic laparoscopic gynecological surgeries of woman by choosing the type of anesthesia (general anesthesia or spinal anesthesia)
Design
Clinical trial with intervention and control groups, with parallel groups,unidirectional blinded, randomized, sample of 74 patients. Rand list software was used for randomization.
Settings and conduct
All patients who are candidates for diagnostic laparoscopic gynecology at Al-Zahra Hospital in Tabriz will be included in this study. Patients are randomly assigned to intervention and control groups,in which, the intervention group spinal anesthesia and in the control group, general anesthesia will be applied. To compare the hemodynamic and respiratory consequences in these patients. In this study,only the data analyzer are blinded to the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Female with physical condition ASA(American Society of Anesthesiologists) class I or II, In the age range of 60-18 years, candidate for laparoscopic gynecological surgery, Patient consent to study. Exclusion criteria: Existence of any contraindications to regional anesthesia, Sensitivity to local anesthetics, Excessive obesity, Accompanying systemic diseases such as any history of cardiovascular, pulmonary, hepatic, renal, etc.
Intervention groups
Control group:34 patients will undergo general anesthesia and the hemodynamic and respiratory consequences will be evaluated. Intervention group:34 patients will undergo spinal anesthesia and the hemodynamic and respiratory consequences will be evaluated.
Main outcome variables
Systolic and diastolic blood pressure, Mean arterial pressure, Heart rate, Saturation of peripheral oxygen, Severity of postoperative nausea and vomiting, Severity of postoperative pain

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180411039267N4
Registration date: 2021-02-15, 1399/11/27
Registration timing: registered_while_recruiting

Last update: 2021-02-15, 1399/11/27
Update count: 0
Registration date
2021-02-15, 1399/11/27
Registrant information
Name
Reyhaneh Abri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3476 7121
Email address
re.abri@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-29, 1399/11/10
Expected recruitment end date
2021-07-01, 1400/04/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the changes in hemodynamic and respiratory parameters in two methods of spinal anesthesia versus general anesthesia in diagnostic gynecologic laparoscopy
Public title
Comparison of hemodynamic and respiratory changes in anesthesia and laparoscopic gynecological surgeries
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Female with physical condition ASA(American Society of Anesthesiologists) class I or II In the age range of 60-18 years candidate for laparoscopic gynecological surgery Patient consent to study
Exclusion criteria:
Existence of any contraindications to regional anesthesia Sensitivity to local anesthetics Excessive obesity Accompanying systemic diseases such as any history of cardiovascular, pulmonary, hepatic, renal, etc.
Age
From 18 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Data analyser
Sample size
Target sample size: 74
Randomization (investigator's opinion)
Randomized
Randomization description
Using a table of random numbers that includes numbers from 1 to 74 and with each referral up to 74th patient,each time we randomly select a number from the number table(by calculators random numbers system and each number will have a chance to happen only once) and depending on what number comes up,each patient is placed in one of the two intervention groups (37 people) and the control group (37 people).Thus,if our random number was odd, the patient will be in the intervention group and will undergo spinal anesthesia and if our random number was even,the patient will undergo general anesthesia in the control group.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the anesthesiologist is fully aware of the groupings because he has to induce general anesthesia and anesthesia on patients. The same anesthesiologist and nurse collected the data during the operation and recovery, and the patient are Conscious of anesthesia or numbness, and only the data analyzer is blind to the study.
Placebo
Not used
Assignment
Factorial
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethic Committee of Tabriz University of Medical Sciences
Street address
Vice chancellor for research, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5183915881
Approval date
2021-01-25, 1399/11/06
Ethics committee reference number
IR.TBZMED.REC.1399.973

Health conditions studied

1

Description of health condition studied
Comparison of hemodynamic and respiratory changes in spinal anesthesia and general anesthesia in diagnostic laparoscopy in women
ICD-10 code
T88.59
ICD-10 code description
Other complications of anesthesia

Primary outcomes

1

Description
Systolic and diastolic blood pressure
Timepoint
From the beginning of anesthesia to 30th minute,every 5 minutes and after that every 15minutes and in recovery section until discharging,every 10 minutes.
Method of measurement
Mercury barometer

2

Description
Mean arterial pressure(MAP)
Timepoint
From the beginning of anesthesia to 30th minute,every 5 minutes and after that every 15minutes and in recovery section until discharging,every 10 minutes.
Method of measurement
Mercury barometer

3

Description
Heart rate
Timepoint
From the beginning of anesthesia to 30th minute,every 5 minutes and after that every 15minutes and in recovery section until discharging,every 10 minutes.
Method of measurement
Counting in each minutes

4

Description
Saturation of peripheral oxygen
Timepoint
From the beginning of anesthesia to 30th minute,every 5 minutes and after that every 15minutes and in recovery section until discharging,every 10 minutes.
Method of measurement
Via the Pulse Oximeter

Secondary outcomes

1

Description
Severity of postoperative nausea and vomiting
Timepoint
Every 5 minutes in recovery until discharge from recovery and transfer to ward
Method of measurement
scoring by (0=non, 1=nausea, 2=vomiting, 3=vomiting >2 times)

2

Description
Severity of postoperative pain
Timepoint
Recovery and at 3, 6, 12,18 and 24 hours postoperatively
Method of measurement
Four Numerical Verbal Rating Scale

Intervention groups

1

Description
Control group:37 patients will be placed under general anesthesia with induction and maintenance of anesthesia with 1% intravenous propofol drug of Dongkook pharmaco company made in Korea and endotracheal intubation will be performed for controlled breathing during surgery and hemodynamic and respiratory consequences (such as Systolic and diastolic blood pressure, mean arterial pressure, heart rate, saturation of peripheral oxygen, severity of nausea and vomiting, severity of pain )during and after surgery will be assessed.
Category
Prevention

2

Description
Intervention group:37 patients undergoing spinal anesthesia with spinal injection of topical anesthetic bupivacaine 5% hyperbaric manufactured by aspen company and spontaneous respiration will be maintained and hemodynamic and respiratory consequences (such as systolic and diastolic blood pressure, mean arterial pressure, heart rate, saturation of peripheral oxygen, severity of nausea and vomiting, severity of pain)during and after surgery will be assessed.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Reyhaneh Abri
Street address
Alzahra hospital, South artesh street
City
Tabriz
Province
East Azarbaijan
Postal code
5138663134
Phone
+98 41 3553 9163
Fax
+98 41 3553 9163
Email
alzahrahosp@tbzmed.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Abolghasem Joyban
Street address
Vice chancellor for research, ِDaneshgah street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Phone
+98 41 3335 7310
Fax
+98 41 3335 7310
Email
research-vice@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Reyhaneh Abri
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Operating room-alzahra hospital- south artesh st
City
Tabriz
Province
East Azarbaijan
Postal code
5138663134
Phone
+98 41 3476 7121
Fax
+98 41 3334 1994
Email
reyhane.abri@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Reyhaneh Abri
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Operating room-alzahra hospital- south artesh st
City
Tabriz
Province
East Azarbaijan
Postal code
5138663134
Phone
+98 41 3476 7121
Fax
+98 41 3334 1994
Email
reyhane.abri@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Reyhaneh Abri
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Operating room-alzahra hospital- south artesh st
City
Tabriz
Province
East Azarbaijan
Postal code
5138663134
Phone
+98 41 3476 7121
Fax
+98 41 3334 1994
Email
reyhane.abri@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All potential data can be shared after making peoples unrecognizable.
When the data will become available and for how long
Starting 6 months after publication
To whom data/document is available
Documents will be available for people working in academic institutions and also people working in businesses
Under which criteria data/document could be used
There will be no specific limitations to the utilization of the data
From where data/document is obtainable
Dr .Reyhaneh Abri, Department of Anesthesiology, Faculty of Medicine, Golgasht Street, Tabriz East Azarbaijan Islamic Republic of Iran ,Phone+98 413 3341994, Fax+98 41 33341994 , re.abri@tbzmed.ac.ir
What processes are involved for a request to access data/document
Applicants will access the data from the present study by sending an email to the responsible author for a maximum of one week.
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