If we observe the positive effects of the dose of ketamine and lidocaine on the prevention of emergence agitation (EA) and pain after rhinoplasty surgery, this method can be used to prevent EA and postoperative pain in rhinoplasty and other surgeries.
Design
A clinical trial with three groups of control, lidocaine and ketamine with parallel groups , phase 3, randomized, one side blinded on 72 patients, coin flip is used for randomization.
Settings and conduct
All patients referred for elective rhinoplasty surgery who are eligible for the study and have undergone general anesthesia.
Operating room of Amirkabir Hospital in Arak
. The method of induction of anesthesia will be the same in all three groups
20 minutes before the end of surgery patients in the control group will receive 1 ml of normal saline and patients in the ketamine group / 5. Mg / kg ketamine and patients in the lidocaine group 1.5 mg / kg lidocaine intravenously with similar syringes. After estuation and transfer of the patient to recovery room, the patient's restlessness will be recorded by the RASS scale every 10 minutes until discharge from the recovery by a trained nurse. Also, the amount of postoperative pain will be recorded by the Numerical Pain Measurement Scale (NRS) every 10 minutes.
Participants/Inclusion and exclusion criteria
All patients referred for elective rhinoplasty surgery who are eligible for the study and have undergone general anesthesia.
Comparison of effect of ketamine and lidocaine on prevention of emergence agitation in Rhinoplasty
Public title
Comparison of effect of ketamine and lidocaine on prevention of emergence agitation in Rhinoplasty
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Referral for elective rhinoplasty surgery
Age 18-45 years
Lack of known allergies to the drugs used in the present study
No pregnancy
No drug addiction
Do not use psychotropic drugs
Perform surgery under general anesthesia
Classification of ASA class, I-II
Exclusion criteria:
Taking painkillers and sedatives 24 hours before surgery
History of heart disease, nervous system, and neurological disorders
Patient with a history of previous rhinoplasty
History of seizures
Duration of anesthesia and surgery more than 2 hours
Age
From 18 years old to 45 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method is to flip a coin and based on the sample size, the same number of coins will be thrown. If head is observed, the patient will be in the ketamine group and otherwise in the lidocaine group.
Blinding (investigator's opinion)
Single blinded
Blinding description
This randomized study is one side blinded because the patient does not know which treatment or medication he/she is receiving
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical sciences
Street address
Sardasht
City
Arak
Province
Markazi
Postal code
3819693345
Approval date
2022-01-22, 1400/11/02
Ethics committee reference number
IR.ARAKMU.REC.1400.281
Health conditions studied
1
Description of health condition studied
rhinoplasty surgery
ICD-10 code
J95-J95
ICD-10 code description
Intraoperative and postprocedural complications and disorders of the respiratory system, not elsewhere classified
Primary outcomes
1
Description
Restlessness when waking up from anesthesia
Timepoint
During anesthesia until the end of the patient's presence in the recovery room, the patient's vital signs will be measured. Also, during the presence at recovery, the RASS and NRS questionnaires will be filled in.
Method of measurement
After extubation and transfer of the patient to recovery room, the patient's restlessness will be recorded by the RASS scale every 10 minutes until discharge from the recovery by a trained nurse who does not know the patient group. Also, after transferring the patient to recovery room, the amount of postoperative pain will be recorded by the Numerical Pain Measurement Scale (NRS) every 10 minutes.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group: Lidocaine group: 1.5 mg / kg lidocaine intravenously 20 minutes before surgery completion
Category
Prevention
2
Description
Intervention group: Intervention group: Ketamine group: 5 /. Mg / kg of ketamine 20 minutes before surgery completion
Category
Prevention
3
Description
Control group: 20 minutes before surgery completion to patients in the control group 1 ml of normal saline intravenously
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Amirkabir hospital
Full name of responsible person
Fateme Ebrahimi
Street address
Alamolhoda
City
Arak
Province
Markazi
Postal code
3819693181
Phone
+98 86 3313 4716
Email
s_omidvar1991@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Alireza Kamali
Street address
Sardasht
City
Arak
Province
Markazi
Postal code
3815697854
Phone
+98 86 3383 8330
Email
alikamaliir@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Safoora Omidvar
Position
professor
Latest degree
Master
Other areas of specialty/work
Anesthesiology
Street address
Sardasht
City
Arak
Province
Markazi
Postal code
3815697854
Phone
+98 71 5335 2678
Email
s_omidvar1991@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Safoora Omidvar
Position
Professor
Latest degree
Master
Other areas of specialty/work
Anesthesiology
Street address
Sardasht
City
Arak
Province
Markazi
Postal code
3815697854
Phone
+98 86 3417 3526
Fax
Email
s_omidvar1991@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Safoora Omidvar
Position
professor
Latest degree
Master
Other areas of specialty/work
Anesthesiology
Street address
Sardasht
City
Arak
Province
Markazi
Postal code
3815697854
Phone
+98 71 5335 2678
Email
s_omidvar1991@yahoo.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
There is no more information
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