Ignite Creation Date:
2024-05-06 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 1:53 PM
Study NCT ID:
NCT04705948
Status:
COMPLETED
Last Update Posted:
2021-05-11
First Post:
2021-01-08
Brief Title:
Comparing the Effect of Ketamine and Magnesium Sulfate Gargling With Placebo on Post-operative Sore Throat
Sponsor:
University Tunis El Manar
Organization:
University Tunis El Manar
Study Overview
Official Title:
Comparing the Effect of Ketamine and Magnesium Sulfate Gargling With Placebo on Post-operative Sore Throat A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2021-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A prospective randomized double-blind study including patients ASA I-II aged more than 18 years undergoing surgery under general anesthesia GA and endotracheal intubation Patients were randomized allocated into 2 groups ketamine group received ketamine gargle 05 mgkg up to 30 ml dextrose water and magnesium group received magnesium sulfate gargle 20 mgkg up to 30 mL dextrose water 15 minutes before the operation
Our primary outcome is sore throat and the secondary judging criteria are cough dysphonia and satisfaction A standardized anesthesia protocol was followed for all patients After extubation the patients were asked to grade POST hoarseness and cough at 15 min 1h and 24 h
Our primary outcome is sore throat and the secondary judging criteria are cough dysphonia and satisfaction A standardized anesthesia protocol was followed for all patients After extubation the patients were asked to grade POST hoarseness and cough at 15 min 1h and 24 h
Detailed Description:
This is a prospective single-center randomized double-blind study the investigators included in the study the patients
whose age is greater than or equal to 18 years ASA class 1 or 2 proposed for elective visceral orthopedic oncology ophthalmologic urologic surgery under general anesthesia with orothracheal intubation expected duration 120 min
the non-inclusion criteria are known allergy to ketamine or maguisuim sulphate ASA 3 and more cervical surgery rapid sequence induction difficult intubation planned or history of difficult intubation malformation of the ORL sphere upper respiratory tract infections the need for multiple laryngoscopies for orotracheal intubation 2 attempts the need for a postoperative nasogastric tube
randomization is performed upon entering the operating room The gargle allocation scheme Ketamine Group or Magnesium Sulfate Group was randomly generated using a randomization table with an allocation ratio of 1 1
Postoperative follow-up was carried out in the post-intervention monitoring room then in hospitalization within the various referring services general surgery orthopedics ORL and ophthalmology
On the day of the procedure the doctor responsible for the study prepares the two types of solutions containing
One of magnesium sulfate 20mg kg diluted in 30cc of 5 glucose serum
The other ketamine 50mg diluted in 30cc of 5 glucose serum These two solutions were distributed over two groups of patients for use as a gargle lasting at least 60 seconds for each patient in each group and 15 minutes before the surgery
The primary endpoint is the incidence and severity of POST at the twenty-fourth hour postoperatively The secondary outcomes are the incidence and severity of POST at 15 minutes and one hour postoperatively The occurrence of cough The presence of dysphonia and Patient satisfaction
The severity of POST was scored on a three-point score from 0 to 2 0 No pain 1 Oropharyngeal pain on speaking 2 Spontaneous oropharyngeal pain
whose age is greater than or equal to 18 years ASA class 1 or 2 proposed for elective visceral orthopedic oncology ophthalmologic urologic surgery under general anesthesia with orothracheal intubation expected duration 120 min
the non-inclusion criteria are known allergy to ketamine or maguisuim sulphate ASA 3 and more cervical surgery rapid sequence induction difficult intubation planned or history of difficult intubation malformation of the ORL sphere upper respiratory tract infections the need for multiple laryngoscopies for orotracheal intubation 2 attempts the need for a postoperative nasogastric tube
randomization is performed upon entering the operating room The gargle allocation scheme Ketamine Group or Magnesium Sulfate Group was randomly generated using a randomization table with an allocation ratio of 1 1
Postoperative follow-up was carried out in the post-intervention monitoring room then in hospitalization within the various referring services general surgery orthopedics ORL and ophthalmology
On the day of the procedure the doctor responsible for the study prepares the two types of solutions containing
One of magnesium sulfate 20mg kg diluted in 30cc of 5 glucose serum
The other ketamine 50mg diluted in 30cc of 5 glucose serum These two solutions were distributed over two groups of patients for use as a gargle lasting at least 60 seconds for each patient in each group and 15 minutes before the surgery
The primary endpoint is the incidence and severity of POST at the twenty-fourth hour postoperatively The secondary outcomes are the incidence and severity of POST at 15 minutes and one hour postoperatively The occurrence of cough The presence of dysphonia and Patient satisfaction
The severity of POST was scored on a three-point score from 0 to 2 0 No pain 1 Oropharyngeal pain on speaking 2 Spontaneous oropharyngeal pain
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None