Determining and comparing the effect of caffeine and doxapram on respiratory parameters of patients admitted to intensive care units after spinal surgery
Design
A randomized, double-blinding clinical trial, with the parallel groups, Phase 3 on 96 patients
Settings and conduct
In this randomized double-blind clinical trial study, 96 eligible patients undergoing spinal surgery admitted to the intensive care unit of Al-Zahra Hospital in Isfahan will be included in the study and will be randomly divided into three groups. Patients in the first group will be prescribed doxapram, in the second group "caffeine citrate", and in the third group "normal saline", then their hemodynamic parameters will be compared between the three groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria include the age group of 18-70 years, has a class 1 and 2 classification of the American Society of Anesthesiologists (ASA), a candidate for spine surgery and consent to participate in the study.
Exclusion criteria are confirmed cerebral edema, sensitivity to the studied drugs, having hemoglobin less than 9 g/dl and having a history of underlying diseases (such as cardiovascular disease, lung disease, hypertension, hyperthyroidism).
Intervention groups
Intervention group 1: Patients in this group will be infused with doxapram 5 mg / kg for three hours.
Intervention group 2: Patients in this group will be infused with caffeine citrate 5 mg / kg for three hours.
Control group: Patients in this group will be infused with 250 cc of normal saline (as a placebo) for three hours.
Comparative study of the effect of caffeine and doxapram on respiratory parameters of patients admitted to intensive care units after spinal surgery
Public title
Comparison of the effect of caffeine and doxapram on respiratory parameters of patients after spinal surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age category 70-18 years
Class I and II classification of the American Society of Anesthesiologists(ASA)
Candidate for spine surgery
Satisfaction to participate in the study
Exclusion criteria:
Existence of confirmed cerebral edema
Sensitivity to the studied drugs
Having hemoglobin less than 9 g/dL
Having a history of underlying diseases (such as cardiovascular disease, lung disease, hypertension, hyperthyroidism)
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, 96 eligible patients are randomly selected. For this, the letter A is written on 32 sheets, the letter B is written on 32 sheets, and the letter C is written on 32 sheets and each of them is placed in an envelope. Each patient is then asked to choose one of the envelopes. Depending on the selected envelope, the patient is assigned to one of three groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, two drugs, doxapram, caffeine and placebo, are pre-prepared by the pharmacist in the same shape and color and placed in coded packages and delivered daily to the researcher, who is unaware of the type of each. Medications are prescribed. Also, the person recording the clinical and basic information of the patients as well as the statistical analyst will not be aware of the type of intervention.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Street address Isfahan University of Medical Sciences, Hezar Jarib Ave., Azadi Sq
City
Isfahan
Province
Isfehan
Postal code
8179964167
Approval date
2020-01-09, 1398/10/19
Ethics committee reference number
IR.MUI.MED.REC.1398.514
Health conditions studied
1
Description of health condition studied
Spinal surgery
ICD-10 code
M43.20
ICD-10 code description
Fusion of spine, site unspecified
Primary outcomes
1
Description
Respiratory Rate
Timepoint
Half an hour before entering the intensive care unit and at 6, 12, 18, 24, 30, 36, 42, 48 hours after intervention
Method of measurement
Ventilator device
2
Description
Oxygen saturation(SPO2)
Timepoint
Half an hour before entering the intensive care unit and at 6, 12, 18, 24, 30, 36, 42, 48 hours after intervention
Method of measurement
Ventilator device
3
Description
Blood pressure
Timepoint
Half an hour before entering the intensive care unit and at 6, 12, 18, 24, 30, 36, 42, 48 hours after intervention
Method of measurement
Ventilator device
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Patients in this group will be infused with doxapram(BehbodDaroo Company) 1 mg / kg for three hours.
Category
Treatment - Drugs
2
Description
Intervention group 2: Patients in this group will be infused with caffeine citrate (Chemidarou Company) 5 mg / kg for three hours.
Category
Treatment - Drugs
3
Description
Control group: Patients in this group will be infused with 250 cc of normal saline as a placebo (Darou Pakhsh Company) for three hours.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra Hospital
Full name of responsible person
Babak Alikiaii
Street address
Soffe Blvd, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Fax
Email
alikiaiib@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mansour Siavash Dastjerdi
Street address
Vice Chancellor for Research, School of Medicine, Hezar Jarib Street, Isfahan.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8597
Email
dean@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Isfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Babak Alikiaii
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Department of Anesthesiology; Al-Zahra Hospital; Sofeh boulevard
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
alikiaiib@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Babak Alikiaii
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Department of Anesthesiology; Al-Zahra Hospital; Sofeh boulevard
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
alikiaiib@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Abadan University of Medical Sciences
Full name of responsible person
Mohammadhasan Houshmandi
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Department of Anesthesiology; Al-Zahra Hospital; Sofeh boulevard
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
mhhoushmandi@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