The effect of remifentanil on hemodynamic changes and laxity of patients undergoing complete abdominal hysterectomy
Design
This study will be a double-blind randomized clinical trial with factorial groups on 50 patients referred to Peymaniyeh Motahhari Hospital in Jahrom who undergo complete hysterectomy through the abdomen. Patients participating in the study will be divided into two groups by tossing coins.
Settings and conduct
Patients referred to Motahhari Hospital in Jahrom who will undergo complete hysterectomy through the abdomen will be included in the study. Patients participating in the study will be divided into two groups of remifentanil and control by tossing coins. The person participating in the study, the researcher and the data collector will be unaware of the type of drug used.
Participants/Inclusion and exclusion criteria
Inclusion criteria: All patients referred to Motahhari Hospital in Jahrom who underwent complete hysterectomy through the abdomen and expressed their consent to participate in the study. Non-entry conditions: includes patients who do not have hemodynamic stability and suffer from acute and chronic pain.
Intervention groups
Intervention group 1: To maintain anesthesia in this group, remifentanil infusion at a dose of /2 μg / kg / hour and propofol infusion at a dose of 200 μg / kg / h will be used. Intervention group 2: Propofol infusion at a dose of 200 μg / kg / h and N2O will be used as a control group to maintain anesthesia in this group.
Main outcome variables
Hemodynamic changes, patient relaxation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210415050976N9
Registration date:2022-02-16, 1400/11/27
Registration timing:prospective
Last update:2022-02-16, 1400/11/27
Update count:0
Registration date
2022-02-16, 1400/11/27
Registrant information
Name
navid kalani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 5433 6085
Email address
k.navid@juma.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-01, 1400/12/10
Expected recruitment end date
2022-08-01, 1401/05/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of remifentanil on hemodynamic changes and laxity of patients undergoing complete abdominal hysterectomy
Public title
The effect of remifentanil on hemodynamic changes and laxity of patients undergoing complete abdominal hysterectomy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patient consent to study
Anesthesia class one and two
Age 20 to 60 years
Exclusion criteria:
Existence of cervical malignancy
History of diabetes or endometriosis
History of neurological diseases
Abnormal Pap smear
Chronic pelvic pain
History of heart disease or hypertension
Age
From 20 years old to 60 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, block randomization method is used. With the help of the online site (www.sealedenvelope.com/simple-randomiser/v1/lists) randomization, 2 blocks of 25 are created. In each block, randomly classified, 25 patients are assigned to remifentanil group and 25 patients to control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
For blinding in the present study, the double-blind method is used in such a way that 1- the person who reviews the results and 2- the person who performs the injections have no information about which patients received remifentanil and which patients received normal saline as a control group.The drugs are drawn in the same syringes and separated only by the letters A and B and will be given to the injector.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Jahrom University of Medical Sciences
Street address
Jahrom University of Medical Sciences, Shahid Motahari Boulevard, Jahrom
City
Jahrom
Province
Fars
Postal code
7167758256
Approval date
2022-02-05, 1400/11/16
Ethics committee reference number
IR.JUMS.REC.1400.091
Health conditions studied
1
Description of health condition studied
Transe abdominal hysterectomy
ICD-10 code
N99.3
ICD-10 code description
Prolapse of vaginal vault after hysterectomy
Primary outcomes
1
Description
blood pressure
Timepoint
قبل از عمل، بلافاصله بعد از اینداکشن، 5 دقیقه بعد از عمل، 15 دقیقه بعد از عمل و 30 دقیقه بعد از عمل و به محض ورود به ریکاوری
Method of measurement
monitoring
2
Description
Heart Rate
Timepoint
Before surgery, immediately after induction, 5 minutes after surgery, 15 minutes after surgery and 30 minutes after surgery and as soon as recovery begins
Method of measurement
monitoring
3
Description
Being relaxed
Timepoint
At times 15, 30, 45, 60, 90, 120 and 180 during the operation will be examined as a Likert scale (low, medium, high and very high).
Method of measurement
Surgeon satisfaction with the patient's muscle relaxation
Secondary outcomes
1
Description
Bleeding
Timepoint
During the operation at times 15, 30, 45, 60, 90, 120 and 180
Method of measurement
1. In terms of gas (surgical gas with a size of 10 by 16 cm (4 inches): 10 ml and each langaz: 100 ml), very wet langaz: 150 ml / 2. According to the amount of blood in the suction (without Calculation of washing serum)
Intervention groups
1
Description
Intervention group 1: To maintain anesthesia in this group, remifentanil infusion at a dose of /2 μg / kg / hour and propofol infusion at a dose of 200 μg / kg / h will be used.
Category
Treatment - Drugs
2
Description
Control group: Propofol infusion at a dose of 200 μg / kg / hour and N2O will be used as a control group to maintain anesthesia in this group.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Motahhari Hospital of Jahrom city
Full name of responsible person
Navid Kalani
Street address
Jahrom, Shahid Motahari Boulevard
City
Jahrom
Province
Fars
Postal code
71677251542
Phone
+98 71 3525 5652
Email
Navidkalani@ymail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Kavous Solh Joo
Street address
Jahrom University of Medical Sciences
City
Jahrom
Province
Fars
Postal code
7167758256
Phone
+98 71 2536 5231
Email
navidkalani@ymail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Jahrom 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
Jahrom University of Medical Sciences
Full name of responsible person
Navid Kalani
Position
Research Expert
Latest degree
Master
Other areas of specialty/work
Anesthesiology
Street address
Jahrom, Shahid Motahari Boulevard
City
Jahrom
Province
Fars
Postal code
7167758256
Phone
+98 71 2536 5231
Email
k.navid@jums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Navid Kalani
Position
Research Expert
Latest degree
Master
Other areas of specialty/work
Anesthesiology
Street address
Jahrom, Shahid Motahari Boulevard
City
Jahrom
Province
Fars
Postal code
7167758256
Phone
+98 71 2536 5231
Email
k.navid@jums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Navid Kalani
Position
Research Expert
Latest degree
Master
Other areas of specialty/work
Anesthesiology
Street address
Jahrom, Shahid Motahari Boulevard
City
Jahrom
Province
Fars
Postal code
7167758256
Phone
+98 71 2536 5231
Email
k.navid@jums.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