Evaluation of hemodynamic changes after general anesthesia with isoflurane compared with propofol in lumbar disc in prone position
Design
A randomized clinical trial, With parallel groups, No blinding, three-phase, Randomized on 64 patients.
Settings and conduct
The study population was patients aged 20-65 years who are candidates for elective lumbar disc surgery referred to Ayatollah Rouhani Hospital in Babol. Patients are randomly divided into two intervention groups using a random number table by computer.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Age 20-65 years old؛ Elective candidate for lumbar disc surgery؛ The american society of anesthesiologists (ASA) class I&II (Grade 1: no cardiovascular, respiratory, glandular and Grade 2: Controlled diabetes)
Exclusion Criteria: Drug addiction؛ BMI > 30 Kg/m2؛ Patients with airway problems؛ Patients with mental disorders
Intervention groups
Intervention group 1: Induction of anesthesia and prone position of morphine 1 mg/kg will be given and to continue and maintain anesthesia 100-150 µg/ kg/ min propofol 10% infusion.
Intervention group 2: Induction of anesthesia and prone position of morphine will be given 1 mg / kg and 1.5-1% isoflurane will be prescribed to continue and maintain anesthesia.
Main outcome variables
Hemodynamic changes
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191026045245N2
Registration date:2021-09-12, 1400/06/21
Registration timing:registered_while_recruiting
Last update:2021-09-12, 1400/06/21
Update count:0
Registration date
2021-09-12, 1400/06/21
Registrant information
Name
Mohsen Daghmehchi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3233 8301
Email address
m.daghmehchi@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-11, 1400/06/20
Expected recruitment end date
2022-09-11, 1401/06/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Hemodynamic changes after general anesthesia with isoflurane compared with propofol in Lumbar disc in prone position
Public title
Hemodynamic changes after general anesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 20-65 years old
Elective candidate for lumbar disc surgery
The American Society of Anesthesiologists (ASA) class I&II ( Grade 1: No cardiovascular, respiratory, glandular and Grade 2: Controlled diabetes)
Exclusion criteria:
Drug addiction
BMI > 30 Kg/m2
Patients with airway problems
Patients with mental disorders
Age
From 20 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were randomly assigned to two groups of 32 using 4 blocks and 16 blocks with a ratio of 1: 1. The free website www.randomization.com will be used to generate the allocation sequence. The resulting sequence will be written on separate sheets and placed in sealed envelopes and will be provided to the lead researcher for study.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Babol University of Medical Siences
Street address
Daneshgah Square, Ganjafrooz Avenue
City
Babol
Province
Mazandaran
Postal code
4717647745
Approval date
2021-05-15, 1400/02/25
Ethics committee reference number
IR.MUBABOL.REC.1400.147
Health conditions studied
1
Description of health condition studied
Lumbar disc
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Blood Pressure
Timepoint
Before induction of anesthesia, after induction of anesthesia and during the operation every 30 minutes, after octopus of the patient and in recovery every 15 minutes
Method of measurement
Monitoring of blood pressure, mm Hg
2
Description
Heart Rate
Timepoint
Before induction of anesthesia, after induction of anesthesia and during the operation every 30 minutes, after octopus of the patient and in recovery every 15 minutes
Method of measurement
Number per minute
3
Description
O2 saturation
Timepoint
Before induction of anesthesia, after induction of anesthesia and during the operation every 30 minutes, after octopus of the patient and in recovery every 15 minutes
Method of measurement
Pulse oximeter
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Induction of anesthesia and prone position of morphine (Exir company) 1 mg/kg will be given and to continue and maintain anesthesia 100-150 µg/ kg/ min propofol (Aburaihan company) 10% infusion.
Category
Treatment - Drugs
2
Description
Intervention group: nduction of anesthesia and prone position of morphine (Exir company) 1 mg/kg will be given and to continue and 1.5-1% isoflurane (Aburaihan company) will be prescribed to continue and maintain anesthesia.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Rouhani Hospital
Full name of responsible person
Parviz Amri
Street address
Ruhani Hospital, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Province
Mazandaran
Postal code
47176-41367
Phone
+98 11 3233 8301
Email
pamrimaleh@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Reza Ghadimi
Street address
Vice-chancellor Of Research, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Province
Mazandaran
Postal code
47176-41367
Phone
+98 11 3219 7667
Email
rezaghadimi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?