Comparison of Tramadol and Lidocaine and placebo jelly in 150 patients candidate for laparoscopic cholecystectomy from bucking, coughing and sore throat after endotracheal extubation.
This study will be done with aim to compare the effects of lidocaine topical gel with tramadol gel on coughing, straining and throat caused by the endotracheal tube.Inclusion criteria are: age between 20 and 60 years; patient informed consent;patients admitted for cholecystectomy laparoscopic surgery; ASA class 1,2; mallampati 1 or 2 and Exclusion criteria are: history of smoking or drug abuse;a history of catching a cold in the last two weeks; patients with COPD, and convulsions. This is a double blind experimental study. The study population consisted of patients undergoing laparoscopic cholecystectomy that referring to Imam Reza Hospital of Kermanshah and by random permutation blocks150 persons will selected and will divided in five equal groups. All patients in the same way with propofol 2 mg / kg and midazolam 0.01 mg / kg and sufentanil 0.2 mg / kg and neuromuscular 0,5 mg / kg will put under general anesthesia. Isoflurane gas is used to maintain anesthesia.In the first group endotracheal tube cuff with tramadol gel 2.5%, in the second group with tramadol gel 5%, the third group with lidocaine gel 2% and in the fourth group is smeared with 1cc 0f each of pure gel.In the control group do not use the gel and intubation performed as usual.The patients for the occurrence of straining and cough and laryngospasm and bronchospasm will control and data will recorded in a special form. Then all patients at a distance of one, six and twelve hours after the operation will checked in severity of throat pain using the VAS and information will recorded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201507114938N3
Registration date:2016-02-12, 1394/11/23
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-02-12, 1394/11/23
Registrant information
Name
HOSSEIN FARZAM
Name of organization / entity
KERMANSHAH UNIVERSITY OF MEDICAL SCIENCES
Country
Iran (Islamic Republic of)
Phone
+98 83 1835 4434
Email address
hfarzam@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
Expected recruitment start date
2015-03-20, 1393/12/29
Expected recruitment end date
2016-03-19, 1394/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Tramadol and Lidocaine and placebo jelly in 150 patients candidate for laparoscopic cholecystectomy from bucking, coughing and sore throat after endotracheal extubation.
Public title
A comparative study of Tramadol and Lidocaine jelly effect on coughing , straining and sore throat due to tracheal tube
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age between 20 and 60 years; patient informed consent;patients admitted for cholecystectomy laparoscopic surgery; ASA class 1,2; mallampati 1 or 2; TMD >6cm.
Exclusion criteria: history of smoking or drug abuse;a history of catching a cold in the last two weeks; patients with COPD, asthma and convulsions.
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomly by permutation of blocks
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Committee Ethics, Kermanshah University of Medical Sciences
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
kermanshah
Postal code
Approval date
2015-10-24, 1394/08/02
Ethics committee reference number
kUMS.REC.1394.16
Health conditions studied
1
Description of health condition studied
medical surveillance following treatment
ICD-10 code
Z09.0
ICD-10 code description
Follow-up examination after surgery for other conditions
Primary outcomes
1
Description
sore throat
Timepoint
1 and 6 and 12 hourse after extubation
Method of measurement
VAS
2
Description
coughing
Timepoint
Immediately aftr extubation
Method of measurement
By asking of patient
3
Description
straining
Timepoint
extubation time
Method of measurement
By asking of patient
Secondary outcomes
1
Description
laryngospasm
Timepoint
after extubation
Method of measurement
exist - lack
2
Description
bronchospasm
Timepoint
after extubation
Method of measurement
exist - lack
Intervention groups
1
Description
In the first group patients in the same way with propofol 2 mg / kg and midazolam 0.01 mg / kg and sufentanil 0.2 mg / kg and neuromuscular 0,5 mg / kg will put under general anesthesia. Isoflurane gas is used to maintain anesthesia. Then endotracheal tube cuff with tramadol gel 2.5%, is smeared. Then all patients at a distance of one, six and twelve hours after the operation will checked in severity of throat pain using the VAS, and information will recorded.
Category
Treatment - Drugs
2
Description
In the second group patients in the same way with propofol 2 mg / kg and midazolam 0.01 mg / kg and sufentanil 0.2 mg / kg and neuromuscular 0,5 mg / kg will put under general anesthesia. Isoflurane gas is used to maintain anesthesia. Then endotracheal tube cuff with tramadol gel 5%, is smeared. Then all patients at a distance of one, six and twelve hours after the operation will checked in severity of throat pain using the VAS, and information will recorded.
Category
Treatment - Drugs
3
Description
In the third group patients in the same way with propofol 2 mg / kg and midazolam 0.01 mg / kg and sufentanil 0.2 mg / kg and neuromuscular 0,5 mg / kg will put under general anesthesia. Isoflurane gas is used to maintain anesthesia. Then endotracheal tube cuff with tramadol gel 2%, is smeared. Then all patients at a distance of one, six and twelve hours after the operation will checked in severity of throat pain using the VAS, and information will recorded.
Category
Treatment - Drugs
4
Description
In the forth group patients in the same way with propofol 2 mg / kg and midazolam 0.01 mg / kg and sufentanil 0.2 mg / kg and neuromuscular 0,5 mg / kg will put under general anesthesia. Isoflurane gas is used to maintain anesthesia. Then endotracheal tube cuff with tramadol gel 5%, is smeared. Then all patients at a distance of one, six and twelve hours after the operation will checked in severity of throat pain using the VAS, and information will recorded.
Category
Treatment - Drugs
5
Description
In the control group do not use the gel and intubation performed as usual.The patients for the occurrence of straining and cough and laryngospasm and bronchospasm will control by a person who is unaware of the type of gel used and data will recorded in a special form. Then all patients at a distance of one, six and twelve hours after the operation will checked in severity of throat pain using the VAS, and information will recorded
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Maryam Rahmatinejad
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Kermanshah University of Medical Sciences
Full name of responsible person
Koroush Hamzehee
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Kermanshah 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
kermanshah univrsity of medical science
Full name of responsible person
Maryam Rahmatinejad
Position
Resident of Anesthesiolog
Other areas of specialty/work
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Postal code
Phone
+98 83 3427 6301
Fax
Email
dr_m20081362@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Hossein Farzam
Position
Anesthesiologist
Other areas of specialty/work
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Postal code
Phone
+98 83 3427 6301
Fax
Email
hfarzam@kums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Maryam Rahmatinejad
Position
Resident of Anesthesiolog
Other areas of specialty/work
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Postal code
Phone
+98 83 3427 6301
Fax
Email
dr_m20081362@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)