Protocol summary

Summary
The benefits of doxapram on recovery from anesthesia and its consequences in patients with the bariatric surgery. Due to the increasing rate of obesity and bariatric surgery results in a significant increase in acts of witness and of course obstructive sleep apnea is a common cause of morbidity, especially in these acts. The study population of 26 patients with morbid obesity Shahid Modares Hospital who are surgical candidate’s sleeve. Patients randomly into two groups of equal size doxapram and placebo control group (distilled water) before extubation.Patients were divided into groups of (doxapram or placebo) Blind, but the anesthesiologist in the operating room aware of the drug during the operation, including electrocardiography, noninvasive blood pressure, pulse oximetry, Capnography, respiratory gas analysis, temperature monitoring, monitoring of neuromuscular relaxants (TOF) will be. After receiving doxapram and Respiratory Rate Tidal volume measured every two minutes and extubation time and the patient train-of-four monitor and respond to voice commands and hand movement and eye opening and responding to verbal commands and ETCO2 will be filled in the questionnaire. Inclusion criteria: patients with ASA Class I, II; body mass index over 45, patients with a history of OSA; smokers; the patient consent to participate in the plan. Exclusion criteria: use of drugs, cardiac diseases, the cause of longer than 3 hours surgery or surgical complications occur.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017060712203N9
Registration date: 2017-08-15, 1396/05/24
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-08-15, 1396/05/24
Registrant information
Name
Niloufar Massoudi
Name of organization / entity
Shahid Beheshti University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 26 3250 6961
Email address
nmasoudi@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Instructor Development Center Research Shahid Modarrs Hospital, Shahid Beheshti University of Medical Sciences .
Expected recruitment start date
2017-06-22, 1396/04/01
Expected recruitment end date
2018-03-21, 1397/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Advantages of doxapram for post-anesthesia recovery and outcomes in bariatric surgery patients.
Public title
Advantages of doxapram for post-anesthesia recovery and outcomes in bariatric surgery patients.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: patients with ASA Class I, II; body mass index over 45; patients with a history of OSA; smokers; the patient consent to participate in the plan. Exclusion criteria: use of drugs; cardiac diseases; the cause of longer than 3 hours surgery or surgical complications occur.
Age
From 18 years old to 40 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 26
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Shahid Bheshti University of Medical Sciences
Street address
Shahid Bheshti University of Medical Sciences, Arabi Street, Velenjak
City
Tehran
Postal code
Approval date
2017-08-06, 1396/05/15
Ethics committee reference number
IR.SBMU.RETECH.REC.1396.236

Health conditions studied

1

Description of health condition studied
Morbid obesity
ICD-10 code
E66.8
ICD-10 code description
Morbid obesity

Primary outcomes

1

Description
The timing of the return of spontaneous breathing after the injection reverse dose in doxapram group and the control group
Timepoint
since revers dose of muscular blocker until spontaneous respiration
Method of measurement
With the clock

Secondary outcomes

1

Description
train-of-four monitor to determine the recovery time after the reverse dose doxapram group and the control group
Timepoint
Since reversal dose of muscular blocker until return muscular blockage
Method of measurement
With the train-of-four monitor

2

Description
End Tidal Co2 determine the reverse dose doxapram group and the control group in 5 minutes
Timepoint
Every 5 minute
Method of measurement
Capnograhpy

Intervention groups

1

Description
Intervention: Doxapram
Category
Treatment - Drugs

2

Description
control: Normal Salin
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Modares Hospital
Full name of responsible person
Nilofar Massoudi
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Modarrs Hospital, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nilofar Massoudi
Street address
Modarres Hospital, Sa'adat Abad, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Modarrs Hospital, Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Shahid beheshti University of Medical Sciences
Full name of responsible person
Nilofar Massoudi
Position
PhD, Assistant professor
Other areas of specialty/work
Street address
Shahid beheshti University of Medical Science, Arabi Street, Velenjak, Tehran
City
Tehran
Postal code
Phone
+98 21 2207 4088
Fax
Email
massodi@SBMU.ac.ir; psezari@sbmu.ac.ir; fsafari@sbmu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Department of Anesthesiology, Clinical Research and Development Unit at Shahid Modarres Hospital, Sh
Full name of responsible person
Nilofar Massoudi
Position
PhD/ Assistant professor
Other areas of specialty/work
Street address
Modarres Hospital, Sa'adat Abad, Tehran
City
Tehran
Postal code
Phone
+98 21 2207 4088
Fax
Email
massodi@SBMU.ac.ir; psezari@sbmu.ac.ir; fsafari@sbmu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Department of Anesthesiology, Clinical Research and Development Unit at Shahid Modarres Hospital, Sh
Full name of responsible person
Nilofar Massoudi
Position
PhD/ Assistant professor
Other areas of specialty/work
Street address
Shahid Modares Hospital, Sadat Abad, Tehran
City
Tehran
Postal code
Phone
+98 21 2207 4088
Fax
Email
massodi@SBMU.ac.ir; psezari@sbmu.ac.ir; fsafari@sbmu.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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