Purpose: Effect of pharyngeal packs during septorhinoplasty surgery on post operative sore throat and nausea and vomiting. Single-center randomized, Double blind. The minimum sample size for this study was estimated to be 90. The sample size for this study was estimated to be at least 90 Based on a sample size of at least 80% power to test Chi-Square and were calculated using statistical software Ncss and PASS. (P<0.05) was considered significant.
Inclusion criteria: All ASAII-I patients candid septorhinoplasty after regional ethical committee approval and written informed consent to participate in the study.
Exclusion criteria: history of motion sickness; common cold with sore throat; consumption of analgesics in the past 48 hours; a history of substance abuse and smoking; difficult intubation and repeat laryngoscopy. Intervention: group(A), input pharyngeal pack after anesthesia, group( B): without pharyngeal pack. Primary outcome: sore throat. Secondary outcome: nausea and vomiting.
Septorhinoplasty surgery patients were randomly divided into two groups A (with pharyngeal packing) and B (without pharyngeal pack). At the end of surgery pharyngeal pack is withdrawn from the patient's mouth in group A in the operating room. Surgeons, recovery nurses and statistics expert
do not know the patient group. The sore throat in VAS
(Visual Analog Scale) from 0 to 10 and nausea and vomiting (with or without) recorded 0 , 2 , 6 and 24 hours after surgery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013011012094N1
Registration date:2013-05-27, 1392/03/06
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-05-27, 1392/03/06
Registrant information
Name
Majid Razavi
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 915 110 8630
Email address
razavim@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Mashhad University of Medical Sciences
Expected recruitment start date
2013-03-10, 1391/12/20
Expected recruitment end date
2013-07-11, 1392/04/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of pharyngeal packs during septorhinoplasty surgery on post operative sore throat and nausea and vomiting
Public title
Pharyngeal packs during surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: after regional ethical committee approval and written informed consent to participate in the study, all ASAI-II patients candid septorhinoplasty.
Exclusion criteria: history of motion sickness; common cold with sore throat; consumption of analgesics in the past 48 hours; a history of substance abuse and smoking; difficult intubation and repeat laryngoscopy
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
90
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 Mashhad University of Medical Sciences
Street address
Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi apartment, Daneshgah st, Mashhad
City
Mashhad
Postal code
Approval date
2012-11-05, 1391/08/15
Ethics committee reference number
511/3011
Health conditions studied
1
Description of health condition studied
septorhynoplasty
ICD-10 code
J34.2
ICD-10 code description
Deviated nasal septum
Primary outcomes
1
Description
Nausea & Vomiting
Timepoint
Post operative times:0 (recovery), 2 , 6 and 24 h
Method of measurement
Nausea: No or Yes (mild or severe), vomiting: Yes or No
2
Description
Sore throat
Timepoint
Post operative times:0 (recovery), 2 , 6 and 24 h
Method of measurement
Visual analog scale(VAS): Pain from 0=no pain to 10=sever pain
Secondary outcomes
1
Description
Duration of surgery
Timepoint
Beginning of anesthesia until extubation
Method of measurement
Hour
2
Description
Concomitant disease
Timepoint
Questionnaire preoperatively
Method of measurement
Patient history
3
Description
Receiving narcotic
Timepoint
Postoperative time
Method of measurement
The number of narcotic injection. Recorded in the questionnaire
Intervention groups
1
Description
Intervention group A: after induction of anesthesia, a simple cotton gauze (16-layer) put in pharyngeal space by anesthesiologist.
Category
Prevention
2
Description
Intervention group B: without pharyngeal pack
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Dr Majid Razavi
Street address
Department of Anesthesia, Imam Reza Hospital, Ibne Sina Street, Mashhad
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi apartment, Daneshgah street, Mashhad
City
Mashhad
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, Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Dr Majid Razavi
Position
Assistant Professor
Other areas of specialty/work
Street address
Department of Anesthesia, Imam Reza Hospital, Ibne Sina Street, Mashhad
City
Mashhad
Postal code
Phone
+98 51 1852 5209
Fax
+98 51 1852 5209
Email
Razavim@mums.ac.ir; Majmrazavi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University Of Medical Sciences
Full name of responsible person
Dr Majid Razavi
Position
Assistant professor
Other areas of specialty/work
Street address
Department of Anesthesia, Imam Reza Hospital, Ibne Sina Street, Mashhad
City
Mashhad
Postal code
Phone
+98 51 1852 5209
Fax
Email
razavim@mums.ac.ir; majmrazavi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mehryar Taghavi Gilani
Position
Assistant professor
Other areas of specialty/work
Street address
Department of Anesthesia, Imam Reza Hospital, Ibne Sina Street, Mashhad
City
Mashhad
Postal code
Phone
+98 51 1852 5209
Fax
+98 51 1852 5209
Email
Taghavim@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)