Comparison of hemodynamic responses of Pergabaline and fentanyl after endotracheal intubation in lumbar spine surgery
Design
A randomized, double-blind, three-phase, randomized clinical trial performed on 64 patients at random.
Settings and conduct
The population of this study was aged 20-65 years old who referred to Ayatollah Rouhani Hospital in Babol. Patients are randomly divided into two groups with a table of random numbers by computer.Intervention group: 8 hours before surgery, 75 mg capsules containing pregabalin (Sanamod company) are administered orally. In addition, fentanyl (Caspian company) 1 microgram/kg in 50 ml of normal saline will be given 10 minutes before endotracheal intubation.
Control group: Capsules containing placebo are given orally 8 hours before surgery. In addition, fentanyl (Caspian company) 1 microgram/kg in 50 ml of normal saline will be given 10 minutes before endotracheal intubation.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age 20-65 years old؛ The American Society of Anesthesiologists (ASA) class I&II ( Grade 1: No cardiovascular, respiratory, glandular and Grade 2: Controlled diabetes)
Exclusion criteria: Drug addiction؛ hypertension and antihypertensive drugs consumers؛ Difficult intubation؛ Bradycardia
Intervention groups
Intervention group: 8 hours before surgery, 75 mg capsules containing pregabalin (Sanamod company) are administered orally. In addition, fentanyl (Caspian company) 1 microgram/kg in 50 ml of normal saline will be given 10 minutes before endotracheal intubation.
Control group: Capsules containing placebo are given orally 8 hours before surgery. In addition, fentanyl (Caspian company) 1 microgram/kg in 50 ml of normal saline will be given 10 minutes before endotracheal intubation.
Comparison of hemodynamic responses of Pergabaline and fentanyl after endotracheal intubation in lumbar spine surgery : A double-blind clinical trial
Public title
Comparison of pregabalin and fentanyl after endotracheal intubation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 20-65 years old
The American Society of Anesthesiologists (ASA) class I&II ( Grade 1: No cardiovascular, respiratory, glandular and Grade 2: Controlled diabetes)
Exclusion criteria:
Drug addiction
Hypertension and antihypertensive drugs consumers
Difficult intubation
Bradycardia
Age
From 20 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly assigned to two groups of 32 using 4 blocks and 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)
Double blinded
Blinding description
Pregabalin is in the form of capsules. In order to blind the capsules containing placebo, they are selected in a completely identical shape and identical to pregabalin capsules, so that they are completely similar in terms of smell, color and form.
Capsules containing pregabalin and placebo are placed in one-size, one-size-fits-all cans and then a 3-digit code is written on each can. After the patient enters the study, one of these cans is assigned to the patient and the code is written on the can on the patient's file (study checklist). Unlock the codes will be done after the study.
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
2021-05-31, 1400/03/10
Ethics committee reference number
IR.MUBABOL.REC.1400.128
Health conditions studied
1
Description of health condition studied
Acute pain
ICD-10 code
G89.18
ICD-10 code description
Other acute postprocedural pain
Primary outcomes
1
Description
Blood Pressure
Timepoint
Before prescribing the drug; before laryngoscopy; after intubation, 1, 3, 5,10 minutes after intubation؛ after surgical incision
Method of measurement
Monitoring of blood pressure, mm Hg
Secondary outcomes
1
Description
Heart Rate
Timepoint
Before prescribing the drug; before laryngoscopy; after intubation, 1, 3, 5,10 minutes after intubation؛ after surgical incision
Method of measurement
Number per minute
2
Description
O2 saturation
Timepoint
Before prescribing the drug; before laryngoscopy; after intubation, 1, 3, 5,10 minutes after intubation؛ after surgical incision
Method of measurement
Pulse oximeter
Intervention groups
1
Description
Intervention group: 8 hours before surgery, 75 mg capsules containing pregabalin (Sanamod company) are administered orally. In addition, fentanyl (Caspian company) 1 microgram/kg in 50 ml of normal saline will be given 10 minutes before endotracheal intubation
Category
Treatment - Drugs
2
Description
Control group: Capsules containing placebo are given orally 8 hours before surgery. In addition, fentanyl (Caspian company) 1 microgram/kg in 50 ml of normal saline will be given 10 minutes before endotracheal intubation.
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?