A clinical trial to comparison the effectiveness of Sufentanil and ketamine gargle on postoperative sore throat after laryngeal mask insertion in patients undergoing cataract surgery.
Objective: To compare the effectiveness of Sufentanil and ketamine gargle on postoperative sore throat after laryngeal mask insertion in patients undergoing cataract surgery.
Design: A not blinded, block randomized clinical trial.
Study population: Patients who undergoing cataract surgery following general anesthesia and laryngeal mask insertion.
Inclusion criterion: Patients undergoing cataract surgery less than 60 minutes; aged between 18 and 80 years.
Exclusion criteria: Surgery for more than 2 hours; taking the NSAIDS in the past 2 days; addiction and smoking; drug allergies; difficult in laryngeal mask insertion; upper respiratory tract infection; asthma; history of sore throat; obesity; neuromuscular disorders; mental disorder; straining during extubation.
Sample size: 297 cases.
Study intervention: The control group are revising 20 ML of normal saline, intervention group one are revising 50 Mg of ketamine with 20 ML of normal saline and intervention group two are revising 10 Mg of Sufentanil with 20 ML of normal saline and will gargle for 30 minutes before anesthesia.
Study outcome: Evaluation and comparison of sore throat based on visual analogue scale (VAS) and sore throat pain intensity based on generalized estimating equation (GEE) at 3, 6, 12, 24 hours after surgery in intervention groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201511014780N8
Registration date:2016-05-21, 1395/03/01
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-05-21, 1395/03/01
Registrant information
Name
Mohammad Alipour
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1801 2612
Email address
alipourm@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Mashhad University of Medical Sciences
Expected recruitment start date
2016-07-22, 1395/05/01
Expected recruitment end date
2018-03-22, 1397/01/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical trial to comparison the effectiveness of Sufentanil and ketamine gargle on postoperative sore throat after laryngeal mask insertion in patients undergoing cataract surgery.
Public title
Postoperative sore throat (PST) after use of a laryngeal mask airway
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criterion: Patients undergoing cataract surgery less than 60 minutes; aged between 18 and 80 years.
Exclusion criteria: Surgery for more than 2 hours; taking the NSAIDS in the past 2 days; addiction and smoking; drug allergies; difficult in laryngeal mask insertion; upper respiratory tract infection; asthma; history of sore throat; obesity; neuromuscular disorders; mental disorder; straining during extubation.
Age
From 15 years old to 80 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
297
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not 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 building, Daneshgah Street
City
Mashhad
Postal code
9138813944
Approval date
2012-09-22, 1391/07/01
Ethics committee reference number
910569
Health conditions studied
1
Description of health condition studied
Sore throat
ICD-10 code
J39.9
ICD-10 code description
Disease of upper respiratory tract, unspecified
Primary outcomes
1
Description
The sore throat
Timepoint
3, 6, 12 and 24 hours after surgery
Method of measurement
visual analogue scale (VAS)
Secondary outcomes
1
Description
Sore throat pain intensity
Timepoint
3, 6, 12 and 24 hours after surgery
Method of measurement
Generalized estimating equation (GEE)
Intervention groups
1
Description
Control group: who are revising 20 ML of normal saline and will gargle for 30 minutes before anesthesia.
Category
Prevention
2
Description
Intervention group 1: who are revising 50 Mg of ketamine with 20 ML of normal saline and will gargle for 30 minutes before anesthesia.
Category
Treatment - Drugs
3
Description
Intervention group 2: who are revising 10 Mg of Sufentanil with 20 ML of normal saline and will gargle for 30 minutes before anesthesia.