Mechaal Benali
Nabeul, Mrezga Hammamet, 8000, Tunisia
NCT Number: NCT04705948
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Nabeul, Mrezga Hammamet, 8000, Tunisia
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:
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)
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Magnesium sulfate versus ketamine for of post-operative sore throat after endotracheal intubation
Other names: postoperative complication
Time frame: at the twenty-fourth hour postoperatively
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
score of three points: satisfied (2 points); moderately satisfied (1 points); not satisfied (0 points)
Time frame: at the twenty-fourth hour postoperatively
no cough 0 point and presence 1 point
University Tunis El Manar
Other
Comparing the Effect of Ketamine and Magnesium Sulfate Gargling With Placebo on Post-operative Sore Throat: A Randomized Controlled Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06677567
Infections, Otorhinolaryngologic Diseases
Yenimahalle, Ankara, Turkey (Türkiye)
View Trial DetailsNCT06563583
Airway Complication of Anesthesia, Infections
Yenimahalle, Ankara, Turkey (Türkiye)
View Trial DetailsNCT03368599
Hoarseness, Infections
Seongnam-si, Gyeonggi-do, South Korea
View Trial DetailsNCT07138079
Infections, Otorhinolaryngologic Diseases
Yenimahalle, Ankara, Turkey (Türkiye)
View Trial Details