Effect of Propofol, Ketamin and combination of Propofol and Ketamine in prevention of coughing and laryngospasm in patients awakening from general anesthesia
The aim of present study was to compared the effect of small doses of propofol, ketamine and their combination on presence and severity of coughing and laryngospasm. It is a double blinded clinical traial.
Inclusion criteria: ASA class I or II, aged between 7 to 75 years old. Exclusion: bronchial asthma, allergic disorders, upper respiratory infection symptom during the surgery, smoking, medication with ACE inhibitors ,allergic reaction to administered drugs and changing the anesthesia technique. Study population: patients who were scheduled to undergo operations under general anesthesia .
Sample size:160 patients. Routine anesthesia was performed. Patient was set at one of the following groups randomly: propofol group (received propofol 0.25 mg/kg), Ketamine (received ketamine 0.25 mg/kg), combination (with the same doses) and control group (received saline 0.1 ml/kg). . when the patient’s breathing returned to regular spontaneous pattern, or when the patient opened his eyes or made purposeful movements drugs were injwcted.Occurrence and severity of laryngospasm and coughing within 2 minutes after extubation were recorded.then presence and severity of coughing and laryngospasm were recordr in 2 min after extubation.
Grading of laryngospasm 0: no symptoms; 1: stridor; 2: total occlusion of the cords (respiratory efforts with no air movement); 3: cyanosis with evidence for airway obstruction at the level of vocal cords.
Grading of coughing : 0: no incidence of coughing 1: only one cough 2: two coughs to slight coughing 3: severe or repetitive coughing was
Frequency and severity of coughing and laryngospasm was compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201403255362N18
Registration date:2014-05-31, 1393/03/10
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-05-31, 1393/03/10
Registrant information
Name
Mohammadreza Safavi
Name of organization / entity
Anesthesiology and Critical Care Research Center, Isfahan University of Medical Sciences, Isfahan
Country
Iran (Islamic Republic of)
Phone
+98 31 1273 2659
Email address
safavi@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2011-03-20, 1389/12/29
Expected recruitment end date
2012-03-19, 1390/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Propofol, Ketamin and combination of Propofol and Ketamine in prevention of coughing and laryngospasm in patients awakening from general anesthesia
Public title
Effect of Propofol, Ketamin and their combination on post operative coughing
Purpose
Prevention
Inclusion/Exclusion criteria
inclusion criteria:American Society of Anesthesiologists (ASA) class I or II; age between 7 to 75 years old; either sex
exclusion criteria: history of sleep apnea syndrome; developmental disorders, airway or facial abnormalities; bronchial asthma; allergic disorders; upper respiratory infection symptom during the surgery; smoking; medication with ACE inhibitors or ;occurrence of allergic reaction ; need to change the anesthesia technique.
Age
From 17 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
160
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences,Hezarjarib St, Isfahan, Iran
City
Isfahan
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
390523
Health conditions studied
1
Description of health condition studied
post extubation coughing and laryngospasm
ICD-10 code
j95.8
ICD-10 code description
Other postprocedural respiratory disorders
Primary outcomes
1
Description
coughing
Timepoint
between 1 and 3min after intervention
Method of measurement
observation
2
Description
Laryngospasm
Timepoint
between 1 and 3min after intervention
Method of measurement
observation
Secondary outcomes
empty
Intervention groups
1
Description
control group:received propofol 0.1 ml/kg normal saline, Intravenously, when the patient’s breathing returned to regular spontaneous pattern, or when the patient opened his eyes or made purposeful movements
Category
Treatment - Drugs
2
Description
propofol group:received propofol 0.25 mg/kg, Intravenously, when the patient’s breathing returned to regular spontaneous pattern, or when the patient opened his eyes or made purposeful movements
Category
Treatment - Drugs
3
Description
Ketamine group: received ketamine 0.25 mg/kg, Intravenously, when the patient’s breathing returned to regular spontaneous pattern, or when the patient opened his eyes or made purposeful movements
Category
Treatment - Drugs
4
Description
combination group:propofol group:received propofol and ketamine each one, 0.25 mg/kg, Intravenously, when the patient’s breathing returned to regular spontaneous pattern, or when the patient opened his eyes or made purposeful movements
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Kashani Hospital
Full name of responsible person
Mohammadreza Safavi Homami
Street address
Deparment of Anesthesiology, Al zahra Hospital, Sofe Blv, Isfahan, Iran
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr. Mansoor Siavash
Street address
Isfahan University of Medical Science,Hezarjarib st,Isfahan,Iran
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan 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
Isfahan University of Medical sciences
Full name of responsible person
Seyyed Mohammad Reza Safavi Homami
Position
Associsted Professor, Department of Anesthesiology
Other areas of specialty/work
Street address
Department of Anesthesiology Al-Zahra Hospital, Sofe Blv Isfahan
City
Isfahan
Postal code
8174675731
Phone
+98 31 1624 9031
Fax
Email
safavi@med.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical sciences
Full name of responsible person
Seyyed Mohammad Reza Safavi Homami
Position
Associsted Professor, Department of Anesthesiology
Other areas of specialty/work
Street address
Department of Anesthesiology Al-Zahra Hospital, Sofe Blv Isfahan
City
Isfahan
Postal code
Phone
+98 31 1624 9031
Fax
Email
safavi@med.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical sciences
Full name of responsible person
Seyyed Mohammad Reza Safavi Homami
Position
Associsted Professor, Department of Anesthesiology
Other areas of specialty/work
Street address
Department of Anesthesiology Al-Zahra Hospital, Sofe Blv, Isfahan
City
Isfahan
Postal code
Phone
+98 31 1624 9031
Fax
Email
safavi@med.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)