Comparison of intravenous acetaminophen and remifentanil on the airway response to tracheal tube in endoscopic sinus surgery, during and the end of anesthesia: a clinical trial study
We conducted a double blind Randomized Clinical Trial to compare the effect of intravenous acetaminophen as an alternative for remifentanil, with remifentanil on airway response to tracheal tubes during and at the end of anesthesia in Functional Endoscopic Sinus Surgery(FESS). The study population consisted of 70 patient 20-50 years old with ASA1 eligibility criteria who were candidates for functional endoscopic sinus surgery in Rasoul Akram hospital. Patients were excluded with sensitivity to acetaminophen, sensitivity to narcotic drugs and diseases such as asthma and hypertensive. They randomly allocated in two groups: acetaminophen (n=35) and remifentanil (n=35). Remifentanil 0.1μg/kg/min was administered for both groups during anesthesia. In group I, Since the beginning of the nose tampon until extubation, remifentanil infusion was continued, and in group II in the last 20 minutes of surgery, remifentanil infusion was discontinued and intravenous injection of acetaminophen was began. Patient and prescribing were not aware of the nature of the drug and only operating room technician was aware of the prescribing drug(the study was double blind). Cough was assessed with 5-point rating scale that recommended by Minogue and colleagues:1. No cough and no stiffness 2.Calm cough and extubation easily 3. Moderate cough 4. Severe cough or muscle stiffness 5. Vigorous agitation for extubation in awake.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014010714199N4
Registration date:2014-03-13, 1392/12/22
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-03-13, 1392/12/22
Registrant information
Name
Leila Mounesan
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6641 9763
Email address
l-mounesan@farabi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Iran University of Medical Sciences
Expected recruitment start date
2012-07-05, 1391/04/15
Expected recruitment end date
2013-07-21, 1392/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of intravenous acetaminophen and remifentanil on the airway response to tracheal tube in endoscopic sinus surgery, during and the end of anesthesia: a clinical trial study
Public title
Intravenous acetaminophen and remifentanil on the airway response in endoscopic sinus surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Patient's desire to participate in the study and informed consent, ASA1 eligibility criteria, 20-50 years old, Candidate for sinus surgery. Exclusion criteria: Hypertensive, Asthma, Sensitivity to acetaminophen, Sensitivity to narcotic drugs, Chronic obstructive pulmonary disease, A sign of the difficult airway in examination, Aspiration risk, Recent infection of the airways, Chronic cough and liver disorders.
Age
From 20 years old to 50 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences Central Campus, Shahid Hemmat Highway, Adjacent to Milad Tower, Tehran, Iran
City
Tehran
Postal code
Approval date
2011-06-11, 1390/03/21
Ethics committee reference number
273 / د/ 91
Health conditions studied
1
Description of health condition studied
cough
ICD-10 code
R05
ICD-10 code description
cough
Primary outcomes
1
Description
Cough
Timepoint
At the end of surgery
Method of measurement
Observation and Minogue grading
Secondary outcomes
1
Description
Heart rate
Timepoint
Heart rate was recorded at T0 (When the nasal tampons were inserted by surgeon), at T1 (During normal spontaneous breathing) and at T2 (5 min after tracheal extubation).
Method of measurement
Taking the pulse
2
Description
The mean arterial pressure
Timepoint
The mean arterial pressure was recorded at T0 (When the nasal tampons were inserted by surgeon), at T1 (During normal spontaneous breathing) and at T2 (5 min after tracheal extubation).
Method of measurement
Pressure gauge
Intervention groups
1
Description
In the first group, Remifentanil infusion 0/1 µg/kg /min has continued since the nasal tampons were inserted by surgeon until trachea extubation.
Category
Prevention
2
Description
In the second group, remifentanil infusion was discontinued at the last 20 minutes of operation and acetaminophen perfusion(1 gr diluted in 100 cc of normal saline solution with 50 cc syringes in the same remifentanil syringes) was started by pump.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasoul Akram Hospital, Ear-Nose-Throat [ENT] operating room, Department of ear-Nose-Throat [ENT]
Full name of responsible person
Dr.Valiollah Hassani
Street address
Department of ear-Nose-Throat [ENT], Rasoul Akram Hospital, Niyaesh Ave., Sattar Khan St., Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Iran University of Medical Sciences
Full name of responsible person
Dr.Seyed Abbas Motevalian
Street address
Iran University of Medical Sciences Central Campus, Shahid Hemmat Highway, Adjacent to Milad Tower, Tehran, Iran
City
Tehran
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, Iran 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
Rasoul Akram Hospital, Ear-Nose-Throat [ENT] operating room, Department of ear-Nose-Throat [ENT]
Full name of responsible person
Dr.Valiollah hassani
Position
Anesthesiologist
Other areas of specialty/work
Street address
Department of ear-Nose-Throat [ENT], Rasoul Akram Hospital, Niyaesh Ave., Sattar Khan St., Tehran
City
Tehran
Postal code
1445613131
Phone
+98 21 6435 2458
Fax
Email
valiollah_hassani@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rasoul Akram Hospital, Ear-Nose-Throat [ENT] operating room, Department of ear-Nose-Throat [ENT]
Full name of responsible person
Dr.Valiollah Hassani
Position
Anesthesiologist
Other areas of specialty/work
Street address
Department of ear-Nose-Throat [ENT], Rasoul Akram Hospital, Niyaesh Ave., Sattar Khan St., Tehran
City
Tehran
Postal code
1445613131
Phone
+98 21 6435 2458
Fax
Email
valiollah_hassani@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Leila Mounesan
Position
Masters
Other areas of specialty/work
Street address
Center for Academic and Health Policy, No.12, Nosrat St., 16th Azar St., Tehran
City
Tehran
Postal code
Phone
+98 21 6641 9763
Fax
Email
l-mounesan@farabi.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)