Comparative study of the effect of sufentanil and lidocaine mixture in comparison with morphine and lidocaine mixture in the prevention of hypertension and tachycardia in patients under general anesthesia in Khatam Al-Anbia hospital in Shahroud in 1399_1400
Comparative study of the effect of sufentanil and lidocaine mixture in comparison with morphine and lidocaine mixture in the prevention of hypertension and tachycardia in patients under general anesthesia
Design
Patients are divided into two equal groups of 50 based on even and odd numbers. For group A, we inject the combination of sufentanil with lidocaine, and for group B, inject morphine with lidocaine, and measure and record their blood pressure and heart rate 15 times, one minute before the injection and zero (immediately after the injection), 5, 10, and 20 minutes after the injection. The anesthesiologist is in charge of the project. Then data will be analyzed.
Settings and conduct
The present study will be a clinical trial that will be conducted in Khatam Al-Anbia Hospital in Shahroud in 1399-1400 in the operating room.
Sample size: According to Morgan sample size table, we will consider a community of 140 patients, which based on this table, the sample size will be equal to 100 people.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Candidate patients for laparoscopic cholecystectomy with general anesthesia; minimum age 18 years and maximum age 65 years; informed consent. Exclusion criteria: patients with hypertension; cesarean section; history of any cardiovascular disease including HTN CHF, IHD; history of any diagnostic (invasive) and therapeutic procedures on the heart, such as angiography and surgery.
Intervention groups
Group A injects sufentanil with lidocaine and group B injects morphine with lidocaine.
Main outcome variables
Systolic blood pressure, mean and mean and heart rate.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210807052100N1
Registration date:2021-09-03, 1400/06/12
Registration timing:retrospective
Last update:2021-09-03, 1400/06/12
Update count:0
Registration date
2021-09-03, 1400/06/12
Registrant information
Name
navid panahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8802 6180
Email address
navid.pan.np@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-20, 1399/11/01
Expected recruitment end date
2021-06-20, 1400/03/30
Actual recruitment start date
2021-01-20, 1399/11/01
Actual recruitment end date
2021-06-20, 1400/03/30
Trial completion date
2021-06-20, 1400/03/30
Scientific title
Comparative study of the effect of sufentanil and lidocaine mixture in comparison with morphine and lidocaine mixture in the prevention of hypertension and tachycardia in patients under general anesthesia in Khatam Al-Anbia hospital in Shahroud in 1399_1400
Public title
Comparative effect of sufentanil over morphine in the prevention of hypertension and tachycardia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Candidate for laparoscopic cholecystectomy
Age between 18 and 65 years
Exclusion criteria:
Having high blood pressure
Cesarean
History of heart disease including CHF, IHD.
COPD
Allergy to opium
Asthma
History of invasive diagnostic and therapeutic action on the heart
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
100
Actual sample size reached:
100
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
By taking different medications on odd and even days without notifying the patient about their group
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Sharood Azad Islamic University of Medical Sciences
Street address
University Boulevard, Khatam Al-Anbia hospital, Shahroud
City
Shahrood
Province
Semnan
Postal code
3614871151
Approval date
2020-12-27, 1399/10/07
Ethics committee reference number
IR. IAU. SHAHROOD. REC. 1399. 052
Health conditions studied
1
Description of health condition studied
Cholecystitis
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Blood pressure changes
Timepoint
In !5 minutes before, zero and after 5, 10 and 20 minutes
Method of measurement
Cardiac monitoring of blood pressure and heart rate
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group1: -Sofentanil: 0.06-0.05 mg per kg body weightLidocaine: 1-2 mg per kg body weight.
Category
Treatment - Drugs
2
Description
Intervention group 2: Lidocaine: 1-2 mg/kg, Morphine: 2-3 mg/kg
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Khatamalanbia hospital
Full name of responsible person
Yusef Kolukhi
Street address
University Boulevard; Khatam Al-Anbia hospital; Shahroud
City
Shahrood
Province
Semnan
Postal code
3614871151
Phone
+98 23 3239 2661
Email
Navid.pan.np@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr Yusef Kolukhi
Street address
University Boulevard in front of Khatam Al-Anbia Hospital, Shahroud
City
Shahrood
Province
Semnan
Postal code
3614871151
Phone
+98 23 3239 2661
Email
Navid.pan.np@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Private
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
Islamic Azad University
Full name of responsible person
Dr Yusef Kolukhi
Position
Attend
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
University Boulevard, in front of the University of Technology, Khatam Al-Anbia 100-bed hospital
City
Shahrood
Province
Semnan
Postal code
3614871151
Phone
+98 23 3239 2661
Email
Navid.pan.np@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr Yousef Kolukhi
Position
Attend
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
University Boulevard, in front of the University of Technology, Khatam Al-Anbia 100-bed hospital
City
Shahrood
Province
Semnan
Postal code
3614871151
Phone
+98 23 3224 2123
Email
Navid.pan.np@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Navid Panahi
Position
Medical student
Latest degree
A Level or less
Other areas of specialty/work
Anesthesiology
Street address
University Boulevard, in front of the University of Technology, Khatam Al-Anbia 100-bed hospital
City
Shahrood
Province
Semnan
Postal code
3614871151
Phone
+98 21 8802 6108
Email
Navid.pan.np@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