Comparing the Effect of Ketamine and Magnesium Sulfate Gargling With Placebo on Post-operative Sore Throat
Primary Purpose
Postoperative Complications
Status
Completed
Phase
Not Applicable
Locations
Tunisia
Study Type
Interventional
Intervention
Magnesium sulfate versus ketamine
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Complications focused on measuring sore throat, Ketamine, magnesium sulfate, endotracheal intubation
Eligibility Criteria
Inclusion Criteria:
- age is greater than or equal to 18 years
- ASA class 1 or 2
- patients proposed for elective visceral, orthopedic, oncology, ophthalmologic, urologic surgery under general anesthesia with orothracheal intubation
Exclusion Criteria:
- known allergy to ketamine or maguisuim sulphate
- ASA 3 and more
- cervical surgery
- difficult intubation planned or history of difficult intubation
- malformation of the O.R.L sphere
- the need for multiple laryngoscopies for orotracheal intubation (≥ 2 attempts);
- the need for a postoperative nasogastric tube.
Sites / Locations
- Mechaal Benali
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
ketamine group
magnesium sulfate group
Arm Description
ketamine gargle (0.5 mg/kg up to 30 ml dextrose water) 15 minutes before the operation
magnesium sulfate gargle (20 mg/kg up to 30 mL G5%) 15 minutes before the operation.
Outcomes
Primary Outcome Measures
severity of post-operative sore throat
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)
Secondary Outcome Measures
Patient satisfaction
score of three points: satisfied (2 points); moderately satisfied (1 points); not satisfied (0 points)
the incidence of cough
no cough 0 point and presence 1 point
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04705948
Brief Title
Comparing the Effect of Ketamine and Magnesium Sulfate Gargling With Placebo on Post-operative Sore Throat
Official Title
Comparing the Effect of Ketamine and Magnesium Sulfate Gargling With Placebo on Post-operative Sore Throat: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
October 7, 2020 (Actual)
Primary Completion Date
February 7, 2021 (Actual)
Study Completion Date
February 7, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Tunis El Manar
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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 (0.5 mg/kg up to 30 ml dextrose water) and magnesium group received magnesium sulfate gargle (20 mg/kg 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.
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 O.R.L 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, O.R.L 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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Complications
Keywords
sore throat, Ketamine, magnesium sulfate, endotracheal intubation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ketamine group
Arm Type
Experimental
Arm Description
ketamine gargle (0.5 mg/kg up to 30 ml dextrose water) 15 minutes before the operation
Arm Title
magnesium sulfate group
Arm Type
Experimental
Arm Description
magnesium sulfate gargle (20 mg/kg up to 30 mL G5%) 15 minutes before the operation.
Intervention Type
Drug
Intervention Name(s)
Magnesium sulfate versus ketamine
Other Intervention Name(s)
postoperative complication
Intervention Description
Magnesium sulfate versus ketamine for of post-operative sore throat after endotracheal intubation
Primary Outcome Measure Information:
Title
severity of post-operative sore throat
Description
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)
Time Frame
at the twenty-fourth hour postoperatively
Secondary Outcome Measure Information:
Title
Patient satisfaction
Description
score of three points: satisfied (2 points); moderately satisfied (1 points); not satisfied (0 points)
Time Frame
at the twenty-fourth hour postoperatively
Title
the incidence of cough
Description
no cough 0 point and presence 1 point
Time Frame
at the twenty-fourth hour postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age is greater than or equal to 18 years
ASA class 1 or 2
patients proposed for elective visceral, orthopedic, oncology, ophthalmologic, urologic surgery under general anesthesia with orothracheal intubation
Exclusion Criteria:
known allergy to ketamine or maguisuim sulphate
ASA 3 and more
cervical surgery
difficult intubation planned or history of difficult intubation
malformation of the O.R.L sphere
the need for multiple laryngoscopies for orotracheal intubation (≥ 2 attempts);
the need for a postoperative nasogastric tube.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
mechaal benali, PROFESSOR
Organizational Affiliation
university manar Tunis tunisia
Official's Role
Study Director
Facility Information:
Facility Name
Mechaal Benali
City
Nabeul
State/Province
Mrezga Hammamet
ZIP/Postal Code
8000
Country
Tunisia
12. IPD Sharing Statement
Plan to Share IPD
No
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Comparing the Effect of Ketamine and Magnesium Sulfate Gargling With Placebo on Post-operative Sore Throat
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