Comparing sublingual nitroglycerine vs. combination of sublingual nitroglycerine and intravenous neostigmine on inducing hypotension on patients undergoing rhinoplasty in bouali hospital of Tehran 2019
Comparing sublingual nitroglycerine vs. combination of sublingual nitroglycerine and intravenous neostigmine on inducing hypotension on patients undergoing rhinoplasty based on age, sex, operation duration, heart rate, and blood pressure.
Design
Randomized clinical trial, two-arm parallel, three-way blinded, with the controlled group
Settings and conduct
Patients are categorized into A and B group by anesthesiologist using random number table( researcher and patients are blinded ).
One group receives drug while the other group receives placebo. Data noted by the researcher is given to data analyzer who is blinded also.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Elective rhinoplasty
Age between 15-60
ASA class I and II
No addiction
Not included in the study:
Not pleased to be part of the study
History of any drug reaction
Age less than 15 or more than 60
ASA class III or more
addiction
Intervention groups
All the patients received a puff of sublingual Nitroglycerin per each 50 kg of weight. One group receives 0.3 mg/kg of IV placebo and the other group receives 0.3 mg/kg IV Neostigmine( researcher is blinded).
Inducing anesthesia is by 3 ug/kg Fentanyl,0.1-0.2 mg/kg Midazolam, 5 mg/kg Nesdonal and 0.5 mg/kg Atricirium.
Maintaining anesthesia is by infusion of 1 ug/kg Fentanyl, 0.1 mg/kg Atracirium and 6-12 mg/kg/h Propofol.
Main outcome variables
Blood pressure; heart rate; surgery duration
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151201025321N1
Registration date:2019-09-07, 1398/06/16
Registration timing:retrospective
Last update:2019-09-07, 1398/06/16
Update count:0
Registration date
2019-09-07, 1398/06/16
Registrant information
Name
Amirnezam Mir
Name of organization / entity
IAUM , MEDICAL SHCOOL
Country
Iran (Islamic Republic of)
Phone
+98 51 3729 2920
Email address
miramirnezam@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-22, 1397/10/01
Expected recruitment end date
2019-06-22, 1398/04/01
Actual recruitment start date
2019-03-05, 1397/12/14
Actual recruitment end date
2019-07-06, 1398/04/15
Trial completion date
2019-07-07, 1398/04/16
Scientific title
Comparing sublingual nitroglycerine vs. combination of sublingual nitroglycerine and intravenous neostigmine on inducing hypotension on patients undergoing rhinoplasty in bouali hospital of Tehran 2019
Public title
Induced hypotension in rhinoplasty
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
elective rhinoplasty
ASA class I & II
No addiction
age between 15 to 60
Exclusion criteria:
patient not pleased to participate in study
drug reaction history
ASA class III or more
Addiction
Age
From 15 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
First, we designed a 10*6 table of random numbers including numbers from 01 to 60. The researcher will give each patient a number from the top of the list, the next patient will receive the bottom number and so on. patients with even numbers will receive A intervention and patients with odd numbers will receive B intervention.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Patients don't know which drug is used for them.
The surgeon who surveys the consequence of using the drug doesn't know which drug is used for the patient.
Data analyzer don't know which drug is used for the patient.
Researcher don't know which drug is used for the patient.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran Islamic Azad University Of Medical Sciences
Street address
12 Unit, NO 28, W. Kavian, Haghani highway
City
Tehran
Province
Tehran
Postal code
1541737175
Approval date
2019-03-04, 1397/12/13
Ethics committee reference number
IR.IAU.TMU.REC.1398.056
Health conditions studied
1
Description of health condition studied
Induced hypotension
ICD-10 code
I95.2
ICD-10 code description
Hypotension due to drugs
2
Description of health condition studied
Rhinoplasty
ICD-10 code
Z41.1
ICD-10 code description
Encounter for cosmetic surgery - rhinoplasty
Primary outcomes
1
Description
Blood pressure
Timepoint
Every 5 minute in first hour and every 15 minute in next hours
Method of measurement
Sphygmomanometer
2
Description
Heart rate
Timepoint
ٍٍٍٍEvery 5 minute in first hour and every 15 minute in next hours
Method of measurement
Cardiac monitoring screen
3
Description
Operation duration
Timepoint
At the end of the operation
Method of measurement
Digital chronometer
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: This group receives 0.3 mg/kg IV Neostigmine( researcher is blinded). Inducing anesthesia is by 3 ug/kg Fentanyl,0.1-0.2 mg/kg Midazolam, 5 mg/kg Nesdonal and 0.5 mg/kg Atricirium. Maintaining anesthesia is by infusion of 1 ug/kg Fentanyl, 0.1 mg/kg Atracirium and 6-12 mg/kg/h Propofol.
Category
Prevention
2
Description
Control group: This group receives 0.3 mg/kg of IV placebo. Inducing anesthesia is by 3 ug/kg Fentanyl,0.1-0.2 mg/kg Midazolam, 5 mg/kg Nesdonal and 0.5 mg/kg Atricirium. Maintaining anesthesia is by infusion of 1 ug/kg Fentanyl, 0.1 mg/kg Atracirium and 6-12 mg/kg/h Propofol.